Patient And Public Involvement Activities Research Articles

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.

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...

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.

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.

Frequency of reporting on patient and public involvement (PPI) in research studies published in a general medical journal: a descriptive study

ObjectivesWhile documented plans for patient and public involvement (PPI) in research are required in many grant applications, little is known about how frequently PPI occurs in practice. Low levels of...

Ethics and patient and public involvement with children and young people

Patient and public involvement (PPI) is important both in research and in quality improvement activities related to healthcare services . While PPI activities do not require formal ethical approval, they...

Selective patient and public involvement: The promise and perils of pharmaceutical intervention for autism.

BackgroundGuidelines suggest the patient community should be consulted from the outset when designing and implementing basic biomedical research, but such patient communities may include conflicting views. We examined how engagement occurred in one such instance.ObjectiveOur objective was to scrutinize patient and public involvement (PPI) by a pan‐European biomedical consortium working to develop drugs to treat autism. We aimed to use this as an example to illustrate how PPI has been utilized in biomedical research.Setting, participants and analysisTwo public events, one in the UK and one in Denmark were conducted as part of the consortium's on‐going PPI activities in 2014 and 2015. Sixty‐six individuals submitted written comments on the consortium's research after these events. The textual data produced were analysed using a thematic approach. Approximately 71% of respondents reported themselves to be adults on the autism spectrum or parents of children with autism.ResultsThe themes identified illustrated major differences between some community concerns and the biomedical research agenda. While treating autism per se. was seen as problematic by some, treating specific co‐occurring problems was seen as helpful in some circumstances. The biomedical consortium selected PPI with a limited user viewpoint at its outset and more widely once basic research was on‐going.DiscussionThis case illustrates what we term “selective PPI” where only a sympathetic and/or limited patient viewpoint is included. Findings highlight the perils of using selective PPI to legitimise scientific endeavours, and the possibilities for constructive dialogue.

Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

BackgroundDespite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials.ObjectiveTo identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials.DesignA modified Delphi process including a two round online survey and a stakeholder consensus meeting.ParticipantsIn total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty‐seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting.ResultsRound 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants.ConclusionsThe prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

EVALUATION OF PATIENT AND PUBLIC INVOLVEMENT INITIATIVES IN HEALTH TECHNOLOGY ASSESSMENT: A SURVEY OF INTERNATIONAL AGENCIES.

Although there is increased awareness of patient and public involvement (PPI) among health technology assessment (HTA) organizations, evaluations of PPI initiatives are relatively scarce. Our objective as members of Health Technology Assessment International's (HTAi's) Patient and Citizen Involvement Group (PCIG) was to advance understanding of the range of evaluation strategies adopted by HTA organizations and their potential usefulness. In March 2016, a survey was sent to fifty-four HTA organizations through the International Network of Agencies for Health Technology Assessment (INAHTA) and contacts of members of HTAi's PCIG. Respondents were asked about their organizational structure; how patients and members of the public are involved; whether and how PPI initiatives have been evaluated, and, if so, which facilitators and challenges to evaluation were found and how results were used and disseminated. Fifteen (n = 15) programs from twelve countries responded (response rate 27.8 percent) that involved patients (14/15) and members of the public (10/15) in HTA activities. Seven programs evaluated their PPI activities, including participant satisfaction (5/7), process (5/7) and impact evaluations (4/7). Evaluation results were used to improve PPI activities, identify education and training needs, and direct strategic priorities. Facilitators and challenges revolved around the need for stakeholder buy-in, sufficient resources, senior leadership, and including patients in evaluations. A small but diverse set of HTA organizations evaluate their PPI activities using a range of strategies that reflect the range of rationales and approaches to PPI in HTA. It will be important for HTA organizations to draw on evaluation theories and methods.

OP110 Survey Of Health Technology Assessment Evaluation Strategies For Patient And Public Involvement

INTRODUCTION:Although there is increased awareness of patient and public involvement (PPI) among Health Technology Assessment (HTA) organizations, evaluations of PPI initiatives are relatively scarce. Our objective as members of HTAi's Patient and Citizen Involvement Group (PCIG) was to advance understanding of the range of evaluation strategies adopted by HTA organizations and their potential usefulness.METHODS:In March 2016, a survey was sent to HTA organizations through the International Network of Agencies for Health Technology Assessment (INAHTA) and contacts of members of HTAi's PCIG. Respondents were asked about their organizational structure; how patients and members of the public are involved; whether and how PPI initiatives have been evaluated, and, if so, which facilitators and challenges to evaluation were found and how results were used and disseminated.RESULTS:Fifteen programs from twelve countries responded that involved patient (14/15) and members of the public (10/15) in HTA activities. Seven programs evaluated their PPI activities, including participant satisfaction (5/7), process evaluations (5/7) and impact evaluations (4/7). Evaluation results were used to improve PPI activities, identify education and training needs, and direct strategic priorities. Facilitators and challenges revolved around the need for stakeholder buy-in, sufficient resources, senior leadership, and including patients in evaluations. Participants also provided suggestions based on their experiences for others embarking on this work, for example including patients and members of the public in the process.CONCLUSIONS:We identified a small but diverse set of HTA organizations internationally that are evaluating their PPI activities. Our results add to the limited literature by documenting a range of evaluation strategies that reflect the range of rationales and approaches to PPI in HTA. It will be important for HTA organizations to draw on formal evaluation theories and methods when planning future evaluations, and to also share their approaches and experiences with evaluation.

The power of symbolic capital in patient and public involvement in health research.

BackgroundPolicy‐makers and health research funders increasingly require researchers to demonstrate that they have involved patients in the design and conduct of research. However, the extent to which patients and public have the power to get involved on an equal footing is dependent on their economic, cultural, social and symbolic capital.ObjectiveTo explore power relations in patient and public involvement (PPI) in research, particularly how patients may wield symbolic capital to develop a more equal relationship.MethodsNarrative interviews with a maximum variation sample of 38 people involved as patients, carers or public in health research, analysed thematically.FindingsSymbolic capital may be demonstrated in a range of ways (sometimes alongside or in the absence of other forms of capital): illness experience, technical illness knowledge and the challenging outsider. Symbolic capital is unstable and dependent on others for recognition and legitimacy. Nonetheless, participants identify a gradual shift in power relations over time.Discussion and conclusionsResearch into PPI has been conceptually and theoretically poor, limiting our understanding of its mechanisms and wider contextual elements. Our findings demonstrate the importance of reflecting on the forms of power and capital wielded by the health research community, and of acknowledging the way in which PPI is challenging the status quo. As one of the first papers to conceptualize how different forms of symbolic capital operate and their critical role in challenging the balance of power, our findings may help researchers better plan their PPI activities and reflect on their own power.

A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress.

Plain Language Summary Funders of research are increasingly requiring researchers to involve patients and the public in their research. Patient and public involvement (PPI) in research can potentially help researchers make sure that the design of their research is relevant, that it is participant friendly and ethically sound. Using and sharing PPI resources can benefit those involved in undertaking PPI, but existing PPI resources are not used consistently and this can lead to duplication of effort. This paper describes how we are developing a toolkit to support clinical trials teams in a clinical trials unit. The toolkit will provide a key ‘off the shelf’ resource to support trial teams with limited resources, in undertaking PPI. Key activities in further developing and maintaining the toolkit are to:● listen to the views and experience of both research teams and patient and public contributors who use the tools;● modify the tools based on our experience of using them;● identify the need for future tools;● update the toolkit based on any newly identified resources that come to light;● raise awareness of the toolkit and● work in collaboration with others to either develop or test out PPI resources in order to reduce duplication of work in PPI. Background Patient and public involvement (PPI) in research is increasingly a funder requirement due to the potential benefits in the design of relevant, participant friendly, ethically sound research. The use and sharing of resources can benefit PPI, but available resources are not consistently used leading to duplication of effort. This paper describes a developing toolkit to support clinical trials teams to undertake effective and meaningful PPI. Methods The first phase in developing the toolkit was to describe which PPI activities should be considered in the pathway of a clinical trial and at what stage these activities should take place. This pathway was informed through review of the type and timing of PPI activities within trials coordinated by the Clinical Trials Research Centre and previously described areas of potential PPI impact in trials.In the second phase, key websites around PPI and identification of resources opportunistically, e.g. in conversation with other trialists or social media, were used to identify resources. Tools were developed where gaps existed. Results A flowchart was developed describing PPI activities that should be considered in the clinical trial pathway and the point at which these activities should happen. Three toolkit domains were identified: planning PPI; supporting PPI; recording and evaluating PPI. Four main activities and corresponding tools were identified under the planning for PPI: developing a plan; identifying patient and public contributors; allocating appropriate costs; and managing expectations. In supporting PPI, tools were developed to review participant information sheets. These tools, which require a summary of potential trial participant characteristics and circumstances help to clarify requirements and expectations of PPI review. For recording and evaluating PPI, the planned PPI interventions should be monitored in terms of impact, and a tool to monitor public contributor experience is in development. Conclusions This toolkit provides a developing ‘off the shelf’ resource to support trial teams with limited resources in undertaking PPI. Key activities in further developing and maintaining the toolkit are to: listen to the views and experience of both research teams and public contributors using the tools, to identify the need for future tools, to modify tools based on experience of their use; to update the toolkit based on any newly identified resources that come to light; to raise awareness of the toolkit and to work in collaboration with others to both develop and test out PPI resources in order to reduce duplication of work in PPI.Electronic supplementary materialThe online version of this article (doi:10.1186/s40900-016-0029-8) contains supplementary material, which is available to authorized users.

Combining PPI with qualitative research to engage 'harder-to-reach' populations: service user groups as co-applicants on a platform study for a trial.

Plain english summaryIt is recommended that research studies are carried out with or by patients and the public through their involvement from the beginning and in as many stages as possible (known as PPI). Some studies formally invite patients and the public to participate in interviews and focused group discussions to collect views about topics (known as qualitative research). In our study on financial incentives for giving up smoking in pregnancy and breastfeeding, we combined both PPI and qualitative research to include the views of women with a range of experiences of smoking and breastfeeding.We involved two mother and baby groups in disadvantaged areas of North East Scotland and North West England as research partners on our team. First, we asked members to comment on our research plans and documents, which is standard PPI. Second, we asked members to participate in voice recorded discussions, contributing to qualitative research data. These discussions revealed different views from those that we heard through research interviews. They allowed us to develop more relevant research tools and resources. Members also helped us to identify people outside the groups who we could interview.Combining involvement and participation helped us to include the views of a wide range of women from ‘harder-to-reach’ groups who don’t usually take part in research. This was important because the research was intended for women who could benefit from incentives to stop smoking in pregnancy and breastfeed, often present in such groups. Positive continuing relationships and trust improved on involvement or participation alone.ᅟBackgroundPatient and public involvement (PPI) in all research studies is recommended from the earliest point and in as many stages as possible. Qualitative research is also recommended in the early stages of designing complex intervention trials. Combining both together might enable inclusion of ‘harder-to-reach’ perspectives from the target population(s), particularly when the research is intended for their benefit. However, the interface between PPI and qualitative research has received little attention.In a multi-disciplinary, mixed methods study to inform the design of incentive trials for smoking cessation in pregnancy and breastfeeding, we combined PPI and qualitative research, with some overlap. Mother and baby groups from two geographically separate disadvantaged areas, with diverse experiences of the smoking and breastfeeding, but no training or previous involvement in research, were recruited as PPI research grant co-applicants. An iterative partnership approach facilitated involvement in research conduct and design across all project phases. Group PPI members were also invited to contribute to more formal qualitative data collection, as and when indicated by the research questions, and emerging analysis.ResultsWe engaged with ‘harder-to-reach’ women in mother and baby group settings, rather than in academic or home environments. These settings were relaxed and informal, which facilitated rapport-building, disclosures of unexpected information and maintained trust. Twenty-one women participated in standard PPI activities: feedback on study protocols and documents; piloting questionnaires and interview schedules. PPI members voiced some different perspectives from those captured within the qualitative dataset. Nineteen participated in focused qualitative research. Novel aspects were audio recorded PPI discussions, which contributed qualitative data; first, to interpret systematic review findings and construct intervention vignettes for use in the qualitative research; second, to assist with recruitment to improve sample diversity in the formal qualitative dataset; and third, to translate theory and findings presented in a researcher generated logic model into a lay tool. This had face validity for potential trial participants and used the metaphor of a ladder.ConclusionsCombining and overlapping PPI and qualitative research added ‘harder-to-reach’ contributions, sample diversity, trust and engagement in creative approaches beyond what could be achieved through PPI or qualitative research alone.Electronic supplementary materialThe online version of this article (doi:10.1186/s40900-016-0023-1) contains supplementary material, which is available to authorized users.

Developing a toolkit for patient and public involvement in a clinical trials unit

Patient and public involvement (PPI) in research involves the active contribution of members of the public in research studies and within research organisations. PPI is important in ensuring the relevance and quality of general health care research. Funders often now request evidence of prior and future planned PPI in health research. The impact of PPI on various aspects of study development and delivery has been described, from study design through to the dissemination and implementation of study findings. Research, however suggests that PPI is inconsistent in terms of levels of engagement, quality and reporting. Within clinical trials variations in intentions and plans for PPI and the experience and impact of such involvement have been identified. Additionally resources to support PPI in clinical trials are often not used in practice. The University of Liverpool Clinical Trials Research Centre PPI working group decided to design a web based toolkit designed to support the PPI activities in clinical trials. The toolkit will signpost chief investigators and trial teams to a range of tools. The tools are designed to facilitate meaningful and effective PPI at all stages of a clinical trial. The development of the toolkit involves: • Describing the PPI pathway through a clinical trial • Identifying existing internal and external resources to support PPI • Identifying additional required resources • Evaluating the use the resources • Disseminating information about the use and impact of the resources and making improvements and modifications to them based on our experience. The results of developing this toolkit will be presented.

A little more conversation please? Qualitative study of researchers' and patients' interview accounts of training for patient and public involvement in clinical trials.

BackgroundTraining in patient and public involvement (PPI) is recommended, yet little is known about what training is needed. We explored researchers’ and PPI contributors’ accounts of PPI activity and training to inform the design of PPI training for both parties.MethodsWe used semi-structured qualitative interviews with researchers (chief investigators and trial managers) and PPI contributors, accessed through a cohort of clinical trials, which had been funded between 2006 and 2010. An analysis of transcripts of audio-recorded interviews drew on the constant comparative method.ResultsWe interviewed 31 researchers and 17 PPI contributors from 28 trials. Most researchers could see some value in PPI training for researchers, although just under half had received such training themselves, and some had concerns about the purpose and evidence base for PPI training. PPI contributors were evenly split in their perceptions of whether researchers needed training in PPI. Few PPI contributors had themselves received training for their roles. Many informants across all groups felt that training PPI contributors was unnecessary because they already possessed the skills needed. Informants were also concerned that training would professionalise PPI contributors, limiting their ability to provide an authentic patient perspective. However, informants welcomed informal induction ‘conversations’ to help contributors understand their roles and support them in voicing their opinions. Informants believed that PPI contributors should be confident, motivated, intelligent, focussed on helping others and have relevant experience. Researchers looked for these qualities when selecting contributors, and spoke of how finding ‘the right’ contributor was more important than accessing ‘the right’ training.ConclusionsWhile informants were broadly receptive to PPI training for researchers, they expressed considerable reluctance to training PPI contributors. Providers of training will need to address these reservations. Our findings point to the importance of reconsidering how training is conceptualised, designed and promoted and of providing flexible, learning opportunities in ways that flow from researchers’ and contributors’ needs and preferences. We also identify some areas of training content and the need for further consideration to be given to the selection of PPI contributors and models for implementing PPI to ensure clinical trials benefit from a diversity of patient perspectives.