Patient And Public Involvement Activities Research Articles

Reporting involvement activities with children and young people in paediatric research: a framework analysis

BackgroundThe active involvement of patients and the public in the design and delivery of health research has been increasingly encouraged, if not enforced. Knowledge of how this is realised in practice, especially where children and young people (CYP) are concerned, is limited, partly due to the low level of reporting of patient and public involvement (PPI) in general. The aim of this work was to assess how researchers funded by the National Institute for Health and Care Research (NIHR) report the involvement of CYP in the design and conduct of child health research to better understand the opportunities offered to CYP, and the realities of involvement in practice.MethodsA participation matrix, analysis framework and accompanying tools were adapted from existing frameworks, including a child-rights informed framework, the Guidance for Reporting Involvement of Patients and the Public Checklist Short Form (GRIPP2SF), and NIHR reporting expectations. Child-focused research reports were identified from the NIHR Journals Library, including any interventional or observational study involving CYP aged 0–< 24 years. In two co-design workshops with healthcare professionals and CYP, we tested and refined the participation matrix, analysis framework and accompanying tools.ResultsOnly thirty-two NIHR reports out of 169 (19%) were identified as relevant and included reporting of PPI with CYP. We identified significant variability in the way PPI with CYP was reported. Only 4/32 (12%) reports fully met NIHR (and GRIPP2SF) reporting criteria. Only 3/32 (9%) reports formally evaluated or self-reflected on PPI activities with CYP, whilst 15/32 (47%) provided minimal information about CYP involvement. The most common approach to involving CYP (23/32, 72%) was through the medium of existing groups or networks.ConclusionDespite the NIHR’s commitment to increase the quality, transparency, and consistency of reporting PPI, the reporting of involvement with CYP remains sub-optimal. Neglecting to report key details of involvement methods and impacts deprives the research community of knowledge to advance the field of delivering ‘meaningful’ PPI with CYP. Practical guidance on how researchers can report the processes and outputs of CYP involvement more rigorously may help child health researchers to involve them more meaningfully. This research offers practical tools informed by CYP to aid the reporting process.

The patient voice: More than a tick box exercise?

Patient and public involvement (PPI) in healthcare professional education is important, yet publications often provide insufficient detail about the types of involvement patients undertake and the level of autonomy that they have. This study details the factors that promote or hinder PPI within a university healthcare professional education setting and the types of activities members conducted. PPI activities were described and mapped against a framework for PPI in healthcare professional education. Semi-structured interviews with PPI group members explored the motivators, enablers and barriers that influence involvement. The framework highlighted that the PPI group were involved in a range of activities, yet they received limited training for their role and were infrequently involved in planning the activities. When interviewed, PPI members did not consider that these factors were the important promoters or barriers to involvement, instead emphasising five themes: (1) their individual characteristics, (2) factors relating to the university organisation, (3) relationships between themselves, faculty and students, (4) time in their role and (5) evidence of their impact. Supporting PPI members whilst working, rather than provision of formal training was considered most empowering for group members. This was mediated through having enough time in their role to develop supportive relationships with faculty, which in turn promoted self-confidence and increased autonomy. This should be considered when making PPI appointments. Small changes in processes during education planning can make it easier for PPI members to bring their own agenda forward and promote equity during education decision making.

Involving young people in sexual health research and service improvement: conceptual analysis of patient and public involvement (PPI) in three projects

BackgroundAlthough increasingly recognised as valuable within sexual and reproductive health (SRH) research and service improvement, examples of patient and public involvement (PPI) are underdocumented, including specific issues relating to young...

Applying Patient and Public Involvement in preclinical research: A co-created scoping review.

Patient and Public Involvement (PPI) in research aims to improve the quality, relevanceand appropriateness of research. PPI has an established role in clinical research where there is evidence of benefit, and where policymakers and funders place continued emphasis on its inclusion. However, for preclinical research, PPI has not yet achieved the same level of integration. As more researchers, including our team, aim to include PPI in preclinical research, the development of an evidence-based approach is important. Therefore, this scoping review aimed to identify and map studies where PPI has been used in preclinical research and develop principles that can be applied in other projects. A scoping review was conducted to search the literature in Medline (PubMed), EMBASE, CINAHL, PsycInfoand Web of Science Core Collection to identify applied examples of preclinical PPI. Two independent reviewers conducted study selection and data extraction separately. Data were extracted relating to PPI in terms of (i) rationale and aims, (ii) approach used, (iii) benefits and challenges, (iv) impact and evaluationand (v) learning opportunities for preclinical PPI. Findings were reviewed collaboratively by PPI contributors and the research team to identify principles that could be applied to other projects. Nine studies were included in the final review with the majority of included studies reporting PPI to improve the relevance of their research, using approaches such as PPI advisory panels and workshops. Researchers report several benefits and challenges, although evidence of formal evaluation is limited. Although currently there are few examples of preclinical research studies reporting empirical PPI activity, their findings may support those aiming to use PPI in preclinical research. Through collaborative analysis of the scoping review findings, several principles were developed that may be useful for other preclinical researchers. This study was conducted as part of a broader project aiming to develop an evidence base for preclinical PPI that draws on a 5-year preclinical research programme focused on the development of advanced biomaterials for spinal cord repair as a case study. A PPI Advisory Panel comprising seriously injured rugby players, clinicians, preclinical researchersand PPI facilitators collaborated as co-authors on the conceptualization, executionand writing of this review, including refining the findings into the set of principles reported here.

The art of Patient and Public Involvement: exploring ways to research and reduce air pollution through art-based community workshops - a reflective paper.

In this reflective paper we outline and discuss our art-based Patient and Public Involvement (PPI) approach. This exercise held two broad objectives. Firstly, to assist policy makers in understanding the types of interventions communities will find acceptable to address the problem of poor air quality, and secondly, to ascertain community views about our research plans to explore the impact of the planned interventions on neighbourhoods. We reflect on both our approach and the emergent conversations from the PPI activity. Attendees contributed to the process and stressed the importance of not burdening poor neighbourhoods with costly charges as that would ameliorate one health problem but generate others as a consequence of additional financial burden. Equally, they stressed the need to conduct research on matters which they could connect with such as the impact of clean air plans on young children and how information about air pollution is disseminated in their neighbourhoods as and when research findings emerge. This paper offers a conceptual analysis of the art-based PPI method and uniquely draws a connection to the philosophical traditions of Ludwig Wittgenstein. Specifically, we demonstrate how art is conducive to creating a dialogue which is specifically helpful for PPI purposes for both researchers and implementers, and conversely, why traditional conversational approaches may have fallen short of the adequacy mark in this regard.

P119 The Alliance - a framework for conceptualising patient and public involvement in rheumatic and musculoskeletal guidelines implementation

Abstract Background/Aims Over the last two decades, patient and public involvement (PPI) have improved the relevance, appropriateness, quality, and acceptability of rheumatic and musculoskeletal (MSK) research. This has in turn been successfully curated into widely endorsed evidence-based recommendations and guidelines. However, uptake and applicability of guideline recommendations is less than optimal, significant variation exist in care, and health and socio-economic burdens attributed to MSK continues to rise, suggesting an implementation challenge. We conducted a rapid review to investigate the role of PPI in rheumatic/MSK guideline implementation. Methods A comprehensive search was used to identify relevant literature in three databases (Medline, Embase, Cinahl) and two large repositories (WHO, G-IN). A priori eligibility criteria and systematic review-based methods were used to identify primary studies with explicit reference to PPI involvement in a rheumatic/MSK guideline implementation activity. Extracted data from included studies was interrogated by authors for details regarding activities, contexts, outcomes, and impact of PPI in implementation of MSK guidelines and further discussed in review project meetings. Findings were brought together in a narrative synthesis. Recommendations for future research and practice, and a conceptual framework for PPI in rheumatic and musculoskeletal guidelines implementation were co-developed with research team including a public contributor. Results Ten papers were included, only one from the global south. A prevalence of consultative PPI activities in rheumatic/MSK guideline dissemination (e.g., language translations, patient versions of guidelines) was found. Few studies explicitly report high-level PPI engagement in relation to care pathway adjustments, care commissioning, institutional operations and policy with a view to MSK guideline implementations. Training, development, and practice of PPI in MSK guideline implementation were not evidenced to have spread much beyond Europe, though it is acknowledged that these activities may be occurring at low levels but are not yet well reported in literature nor rightly accrued as PPI activities in guideline implementation. The Alliance framework highlighting an iterative process of “creative thinking/co-production” and “strategic doing” was developed to address the challenge of PPI in MSK guideline implementation. The framework guides knowledge translation from guidelines to ensure real world benefits and drive quality improvement for MSK care with patients and for patients, across and within care settings in the global North and South. Conclusion Despite success of PPI in rheumatic/MSK research, oversight or ineffective PPI in guideline implementation may hamper translation of novel advances in MSK care into real world practice and therefore patient benefit. The Alliance framework prioritises effective PPI in MSK guideline implementation design, delivery, and evaluation, ideally applied in parallel with the development of evidence-based guidance recommendations. It highlights continuous application of innovative thinking, dynamic, and impactful collaborations for bridging the evidence-practice gap and improving quality of care for MSK patients globally through novel partnerships. Disclosure O.O. Babatunde: None. S. Dawson: None. J. Brammar: None. K. Dziedzic: None. A.O. Adebajo: None.

Reporting on patient and public involvement (PPI) in research publications: using the GRIPP2 checklists with lay co-researchers

BackgroundPatient and public involvement (PPI) in health and social care research is considered important internationally, with increasing evidence that PPI improves the quality, relevance and outcomes of research. There has been a growth in research publications that describe PPI in the research process, but the frequency and detail of PPI reporting varies considerably. This paper reports on a collaborative study that aimed to describe the extent of PPI in publications from research funded by the Collaboration for Leadership in Applied Health Research and Care (CLAHRC) in the East of England (EoE), part of the National Institute of Health Research (NIHR) in England (2014–2019).MethodsA descriptive study of all research publications (1st January 2014 to 31st October 2017) funded by the NIHR CLAHRC EoE. Members of the Public Involvement in Research group (PIRg), at the University of Hertfordshire, were actively involved, with four PIRg co-researchers. We used an internationally recognised reporting checklist for PPI called the GRIPP2 (Guidance for Reporting Involvement of Patients and the Public, Version 2) to guide the reviewing process.ResultsOut of 148 research papers identified, 16 (14%) reported some aspect of PPI activity and were included for review. Ten of the publications (63%) acknowledged the contributions of PPI individuals and/or groups and five had PPI co-authors. There was considerable variation in the PPI reported in the publications, with some ‘missed opportunities’ to provide detail of PPI undertaken. The perspectives of the co-researchers shaped the reporting of the results from this study. The co-researchers found the GRIPP2-SF (short form) to be useful, but the GRIPP2-LF (long form) was considered over complicated and not user-friendly.ConclusionsThis is one of the first studies to involve lay co-researchers in the review of PPI reporting using the GRIPP2 reporting checklists (GRIPP2-SF and GRIPP2-LF). We make recommendations for a revised version of the GRIPP2-SF, with clearer instructions and three additional sections to record whether PPI is reported in the abstract or key words, in the acknowledgements section, and whether there are PPI co-authors. We also recommend the provision of training and support for patient and public peer reviewers.

P35 Co-producing surgical patient information during COVID-19

IntroductionPatients preparing for surgery are understandably fearful due to the threat of COVID-19. With rapid release of surgical research, we wanted to ensure patients can access the right evidence to make informed decisions. We describe an innovative, digital, patient and public involvement (PPI) strategy designed to engage surgical patients with COVID-19 research as it is released, by producing accessible resources.MethodsWe established a Patient Advisory Group (PAG) to co-produce patient information about having surgery during the pandemic, and the risks of perioperative SARS-CoV-2, using information from the CovidSurg international surgical cohort studies.ResultsThe PAG were keen for patients to understand the high risks of mortality and serious breathing complications associated with perioperative SARS-CoV-2. They wanted detailed information about what patients can do to stay safe and about the measures hospitals are taking to keep them safe. What patients wanted to know was not always what surgeons presupposed.We co-produced patient resources with separate versions for dyslexia and learning disabled patients. We published 18 translations within a few weeks and hosted them in purpose-built web pages. We generated PAG-approved lay summaries to share our original research findings with patients.ConclusionPatients quickly adapted to engage in digital PPI activities during pandemic lockdown conditions. Collaborative working via teleconferencing and shared screens is a productive, inclusive and convenient way to rapidly develop patient information. Clinicians should invite critique and can expect patient engagement to enhance the content and acceptability of patient resources.

Patient and Public Involvement for Dementia Research in Low- and Middle-Income Countries: Developing Capacity and Capability in South Asia.

Background: Patient and public involvement (PPI) is an active partnership between the public and researchers in the research process. In dementia research, PPI ensures that the perspectives of the person with “lived experience” of dementia are considered. To date, in many lower- and middle-income countries (LMIC), where dementia research is still developing, PPI is not well-known nor regularly undertaken. Thus, here, we describe PPI activities undertaken in seven research sites across South Asia as exemplars of introducing PPI into dementia research for the first time.Objective: Through a range of PPI exemplar activities, our objectives were to: (1) inform the feasibility of a dementia-related study; and (2) develop capacity and capability for PPI for dementia research in South Asia.Methods: Our approach had two parts. Part 1 involved co-developing new PPI groups at seven clinical research sites in India, Pakistan and Bangladesh to undertake different PPI activities. Mapping onto different “rings” of the Wellcome Trust's “Public Engagement Onion” model. The PPI activities included planning for public engagement events, consultation on the study protocol and conduct, the adaptation of a study screening checklist, development and delivery of dementia training for professionals, and a dementia training programme for public contributors. Part 2 involved an online survey with local researchers to gain insight on their experience of applying PPI in dementia research.Results: Overall, capacity and capability to include PPI in dementia research was significantly enhanced across the sites. Researchers reported that engaging in PPI activities had enhanced their understanding of dementia research and increased the meaningfulness of the work. Moreover, each site reported their own PPI activity-related outcomes, including: (1) changes in attitudes and behavior to dementia and research involvement; (2) best methods to inform participants about the dementia study; (3) increased opportunities to share knowledge and study outcomes; and (4) adaptations to the study protocol through co-production.Conclusions: Introducing PPI for dementia research in LMIC settings, using a range of activity types is important for meaningful and impactful dementia research. To our knowledge, this is the first example of PPI for dementia research in South Asia.

Exploring the impact of patient and public involvement with young people with a chronic condition: A multilevel analysis.

Patient and Public Involvement (PPI) of young people with a chronic condition (YPCC) receives increasing attention. However, evidence of its impact is lacking. This study explores the impact of PPI on outcomes of projects in health and social care, using quantitative measures. Data were collected from projects funded by a 4-year participatory program addressing the social position of YPCC. These projects addressed challenges associated with, for example, going to college with a physical disability, transitions in care and finding a job. Project coordinators filled out project reports with questions about PPI, that is, to what extent were YPCC involved, were they involved as co-deciders and were they involved in developing the project idea. YPCC filled out questionnaires with questions about PPI, that is, the number of PPI activities and self-perceived importance for the project. They also answered questions about the influence of the project on their social position. Based on these questions, a project outcome scale was developed. The data concerned 17 projects and 146 YPCC. Variation existed in project outcomes, of which 27% was associated with differences between projects. Using multilevel analyses, a significant relation was found between the self-perceived importance of YPCC for the project and the project outcomes they experience (0.232, p < 0.01). There was no significant association with the other PPI variables. This study provided some first quantitative evidence that PPI has a positive impact on the YPCC involved. It is suggested that the meaningfulness of PPI matters more to them than the number of activities and amount of influence provided to YPCC. We strongly recommend conducting more research that critically examines impact of PPI.

Impact of involving people with dementia and their care partners in research: a qualitative study

ObjectivesWe aimed to evaluate the impact of patient and public involvement (PPI) at each stage of the research cycle in a dementia research programme.DesignWe used monitoring forms to record the...

Meaningful patient and public involvement to advance healthcare equity, quality and accessibility

Abstract Background A large part of public health is promoting healthcare equity, quality and accessibility. Patient and public involvement (PPI) is a powerful tool to support this goal. It can lead to a richer understanding of public health research topics, improve data quality and analysis, increase trust in and dissemination of research findings, and ultimately achieve health services that are useful, useable and desirable. However, this all relies on PPI being conducted in a meaningful, respectful and inclusive way. Guidance is available on how to conduct, report and evaluate PPI activities. However, evaluative data are often brief, narrative descriptions, which reflects the lack of robust tools specifically developed to assess PPI. The purpose of this study was to develop and pilot tools to objectively assess PPI in the context of research project meetings. Methods PPI and group dynamics literature was used to guide the construction of an observation protocol and questionnaire. The research tools were piloted within a randomised trial of a community intervention for refugee children reporting symptoms of posttraumatic stress. Results The Active Involvement of Users in Research Observation Schedule is a semi-structured observation protocol, which consists of 12 observable behaviours relating to the interpersonal relations between researchers and PPI advisors; the nature of advisor contributions; and how the advisors guide research development. Each category consists of positive and negative behaviours. There is an accompanying paper-based assessment form that allows attendees to independently and anonymously grade the meeting on a list of items that correspond to those on the observation pro-forma. Preliminary inter-rater reliability for the observation protocol is good (ICC=0.833; 95% CI: 0.569-0.947). Conclusions Although the research tools require further refinement and validation, the methodological approach offers a promising, rigorous way to evaluate PPI. Key messages A large part of public health is promoting healthcare equity, quality and accessibility. Patient and public involvement (PPI) is a powerful tool to support this goal. The Active Involvement of Users in Research Observation Schedule and Questionnaire offer a promising, rigorous way to evaluate PPI and promote meaningful involvement to advance public health research.

Utilising Patient and Public Involvement in Stated Preference Research in Health: Learning from the Existing Literature and a Case Study.

Publications reporting discrete choice experiments of healthcare interventions rarely discuss whether patient and public involvement (PPI) activities have been conducted. This paper presents examples from the existing literature and a detailed case study from the National Institute for Health Research-funded PATHWAY programme that comprehensively included PPI activities at multiple stages of preference research. Reflecting on these examples, as well as the wider PPI literature, we describe the different stages at which it is possible to effectively incorporate PPI across preference research, including the design, recruitment and dissemination of projects. Benefits of PPI activities include gaining practical insights from a wider perspective, which can positively impact experiment design as well as survey materials. Further benefits included advice around recruitment and reaching a greater audience with dissemination activities, amongst others. There are challenges associated with PPI activities; examples include time, cost and outlining expectations. Overall, although we acknowledge practical difficulties associated with PPI, this work highlights that it is possible for preference researchers to implement PPI across preference research. Further research systematically comparing methods related to PPI in preference research and their associated impact on the methods and results of studies would strengthen the literature.Electronic supplementary materialThe online version of this article (10.1007/s40271-020-00439-2) contains supplementary material, which is available to authorized users.

Patient and Public Involvement in AMED

Abstract Japan Agency for Medical Research and Development (AMED), established in 2015, is a funding agency that aims to act as a ’control tower’ that directs integrated research, from basic research to practical application. Also, our goal is to fast-track medical R&D that directly benefit people, not only by expending lifespans, but also improving quality of life. So, to improve the quality of clinical researches, AMED conducted a preparatory survey on Patient and Public Involvement (PPI) in clinical researches, which includes comparative policy analysis on PPI strategies and activities in the UK and the US, questionnaire surveys and interviews to patient groups of cancer and rare/intractable diseases in Japan, and a discussion with the expert panel on PPI in Japan. Through this preparatory survey, we define the basic concept of AMED-PPI, and start to encourage PPI in clinical research from FY2019. The Basic Concept of PPI in AMED Definition AMED-PPI is an approach that researchers try to consider patient/public* knowledge and experience to improve the process of their clinical research * patient/public includes survivor, patient/survivor family and future patient Principles more useful findings/results to meet patients’ needs more fast-track clinical researches reduction of risks for research participants (patients) Significance for Researchers Researchers can get a new point of view and find values of their medical researches PPI makes research participants easier to understand the clinical research for Patients and Public PPI can improve convenience and understanding for the research participants PPI can lessen the knowledge and interest for between patients/public and researchers in medical R&Ds Patient and Public Involvement Guidebook (available only in Japanese) https://www.amed.go.jp/ppi/guidebook.html

Embedding patient and public involvement: Managing tacit and explicit expectations

BackgroundEvidencing well‐planned and implemented patient and public involvement (PPI) in a research project is increasingly required in funding bids and dissemination activities. There is a tacit expectation that involving people with experience of the condition under study will improve the integrity and quality of the research. This expectation remains largely unproblematized and unchallenged.ObjectiveTo critically evaluate the implementation of PPI activity, including co‐research in a programme of research exploring ways to enhance the independence of people with dementia.DesignUsing critical cases, we make visible and explicate theoretical and moral challenges of PPI.ResultsCase 1 explores the challenges of undertaking multiple PPI roles in the same study making explicit different responsibilities of being a co‐applicant, PPI advisory member and a co‐researcher. Case 2 explores tensions which arose when working with carer co‐researchers during data collection; here the co‐researcher's wish to offer support and advice to research participants, a moral imperative, was in conflict with assumptions about the role of the objective interviewer. Case 3 defines and examines co‐research data coding and interpretation activities undertaken with people with dementia, reporting the theoretical outputs of the activity and questioning whether this was co‐researcher analysis or PPI validation.ConclusionPatient and public involvement activity can empower individual PPI volunteers and improve relevance and quality of research but it is a complex activity which is socially constructed in flexible ways with variable outcomes. It cannot be assumed to be simple or universal panacea for increasing the relevance and accessibility of research to the public.

Patient and public involvement in dementia research in the European Union: a scoping review

BackgroundInternationally, there is a drive to involve patients and the public in health research, due to recognition that patient and public involvement (PPI) may increase the impact and relevance of health research. This scoping review describes the extent and nature of PPI in dementia research in the European Union (EU) and summarises: (i) how PPI is carried out; and (ii) the impact of PPI on people living with dementia and the public, researchers, and the research process.MethodsRelevant studies were identified by searches in electronic reference databases and then filtered by two reviewers independently. Eligibility criteria for included studies were: (i) people living with dementia and/or care partners; (ii) PPI activity in dementia research conducted in the European Union (EU); and (iii) published between 2000 and 2018. An adapted version of the Guidance for Reporting Involvement of Patients and the Public (GRIPP2 SF) was used to collate the data. There was no language restriction other than the abstract needed to be available in English.ResultsWe found 19 studies from the UK and one from the Netherlands meeting inclusion criteria. No studies from other EU countries met inclusion criteria. Studies reported various methods of PPI including workshops, drop-in sessions, meetings, consensus conference, reader consultation and participatory approach. The reported aims of PPI included identifying and prioritising research questions (n = 4), research design (n = 5), undertaking and managing research (n = 8), and data analysis and interpretation (n = 3). All PPI related to design and implementation of non-pharmacological studies. One study described two pharmacological studies as case studies incorporating PPI. Seventeen studies reported anecdotal impacts of PPI.ConclusionsFurther development of PPI in dementia research in the EU and in pharmacological dementia research is required. Given the wide range of objectives of PPI in dementia research, PPI methods should be flexible and appropriate for the research context. Researchers should also formally evaluate and report the impacts of PPI for researchers, patients and the general public using good quality research designs to foster development of the field and enable the benefits and challenges of PPI to be better understood.Trial registrationPROSPERO 2017: CRD42017053260.

Collaborative and consultative patient and public involvement in sexual health research: lessons learnt from four case studies

Patient and public involvement (PPI) refers to research carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them.1 PPI can include patients, carers, service...

A Hierarchy of Power: The Place of Patient and Public Involvement in Healthcare Service Development.

Amidst statutory and non-statutory calls for effective patient and public involvement (PPI), questions continue to be raised about the impact of PPI in healthcare services. Stakeholders, policy makers, researchers, and members of the public ask in what ways and at what level PPI makes a difference. Patient experience is widely seen as an important and valuable resource to the development of healthcare services, yet there remain legitimacy issues concerning different forms of knowledge that members of the public and professionals bring to the table, and related power struggles. This paper draws on data from a qualitative study of PPI in a clinical commissioning group (CCG) in the UK. The study looked at some of the activities in which there was PPI; this involved researchers conducting observations of meetings, and interviews with staff and lay members who engaged in CCG PPI activities. This paper explores power imbalances when it comes to influencing the work of the CCG mainly between professionals and members of public, but also between different CCG staff members and between different groups of members of public. The authors conclude that a hierarchy of power exists, with some professionals and public and lay members afforded more scope for influencing healthcare service development than others—an approach which is reflected in the ways and extent to which different forms and holders of knowledge are viewed, managed, and utilized.

Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences

Background and aimsHistorically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research funders. We aimed to identify and describe current PPI practice in surgical trials in the United Kingdom, and to explore the views and experiences of surgical trial staff and patient or public contributors in relation to these practices. This was part of a larger study to inform development of a robust PPI intervention aimed at improving recruitment and retention in surgical trials.MethodsOur study had two stages: 1) an online survey to identify current PPI practice in active UK-led, adult surgical trials; and 2) focus groups and interviews with key stakeholders (surgical trial investigators, administrators, and patient or public contributors) to explore their views and experiences of PPI.ResultsOf 129 eligible surgical trial teams identified, 71 (55%) took part in the survey. In addition, 54 stakeholders subsequently took part in focus groups or interviews. Sixty-five (92%) survey respondents reported some kind of PPI, most commonly at the design and dissemination stages and in oversight or advisory roles. The single most common PPI activity was developing participant information sheets (72%). Participants reported mixed practice and views on a variety of issues including the involvement of patients versus lay members of the public, recruitment methods, use of role descriptions and payment for the time of PPI contributors. They suggested some solutions, including the use of written role descriptions and databases of potential PPI contributors to aid recruitment.ConclusionsUK surgical trials involve patients and members of the public in a variety of different ways, most commonly at the beginning and end of the trial lifecycle and in oversight or advisory roles. These are not without challenges and there remain uncertainties about who best to involve, why, and how. Future research should aim to address these issues.

The extent, quality and impact of patient and public involvement in primary care research: a mixed methods study

Plain English summaryIn the UK, more patients go to primary care than other parts of the health service. Therefore it is important for research into primary care to include the insights and views of people who receive these services. To explore the extent, quality and impact of patient and public involvement (PPI) in primary care research, we examined documents of 200 projects and surveyed 191 researchers.We found that about half of studies included PPI to develop research ideas and during the study itself. Common activities included designing study materials, advising on methods, and managing the research. Some studies did not undertake the PPI activities initially planned and funded for. PPI varied by study design, health condition and study population. We found pockets of good practice: having a PPI budget, supporting PPI contributors, and PPI informing recruitment issues. However, good practice was lacking in other areas. Few projects offered PPI contributors training, used PPI to develop information for participants about study progress and included PPI to advise on publishing findings.Researchers reported beneficial impacts of PPI. Most impact was reported when the approach to PPI included more indicators of good practice. The main cost of PPI for researchers was their time. Many reported difficulties providing information about PPI.In partnership with PPI contributors, we have used these findings to develop:a new Cost and Consequences Framework for PPI highlighting financial and non-financial costs, benefits and harms of PPIFifteen co-produced recommendations to improve the practice and delivery of PPI.Background: To improve the lives of patients in primary care requires the involvement of service users in primary care research. We aimed to explore the extent, quality and impact of patient and public involvement (PPI) in primary care research.Methods: We extracted information about PPI from grant applications, reports and an electronic survey of researchers of studies funded by the NIHR School for Primary Care Research (SPCR). We applied recognised quality indicators to assess the quality of PPI and assessed its impact on research.Results: We examined 200 grant applications and reports of 181 projects. PPI was evident in the development of 47 (24%) grant applications. 113 (57%) grant applications included plans for PPI during the study, mostly in study design, oversight, and dissemination. PPI during projects was reported for 83 (46%) projects, including designing study materials and managing the research. We identified inconsistencies between planned and reported PPI. PPI varied by study design, health condition and study population.Of 46 (24%) of 191 questionnaires completed, 15 reported PPI activity. Several projects showed best practice according to guidelines, in terms of having a PPI budget, supporting PPI contributors, and PPI informing recruitment issues. However few projects offered PPI contributors training, used PPI to develop information for participants about study progress, and had PPI in advising on dissemination.Beneficial impacts of PPI in designing studies and writing participant information was frequently reported. Less impact was reported on developing funding applications, managing or carrying out the research. The main cost of PPI for researchers was their time. Many researchers found it difficult to provide information about PPI activities.Our findings informed:a new Cost and Consequences Framework for PPI in primary care research highlighting financial and non-financial costs, plus the benefits and harms of PPIFifteen co-produced recommendations to improve PPI in research and within the SPCR.Conclusions: The extent, quality and impact of PPI in primary care research is inconsistent across research design and topics. Pockets of good practice were identified making a positive impact on research. The new Cost and Consequences Framework may help others assess the impact of PPI.