Dataset Information

From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials.

ABSTRACT:

Unlabelled

: Patient and public involvement (PPI) in research is increasingly required, although evidence to inform its implementation is limited.

Objective

Inform the evidence base by describing how plans for PPI were implemented within clinical trials and identifying the challenges and lessons learnt by research teams.

Methods

We compared PPI plans extracted from clinical trial grant applications (funded by the National Institute for Health Research Health Technology Assessment Programme between 2006 and 2010) with researchers' and PPI contributors' interview accounts of PPI implementation. Analysis of PPI plans and transcribed qualitative interviews drew on the Framework technique.

Results

Of 28 trials, 25 documented plans for PPI in funding applications and half described implementing PPI before applying for funding. Plans varied from minimal to extensive, although almost all anticipated multiple modes of PPI. Interview accounts indicated that PPI plans had been fully implemented in 20/25 trials and even expanded in some. Nevertheless, some researchers described PPI within their trials as tokenistic. Researchers and contributors noted that late or minimal PPI engagement diminished its value. Both groups perceived uncertainty about roles in relation to PPI, and noted contributors' lack of confidence and difficulties attending meetings. PPI contributors experienced problems in interacting with researchers and understanding technical language. Researchers reported difficulties finding 'the right' PPI contributors, and advised caution when involving investigators' current patients.

Conclusions

Engaging PPI contributors early and ensuring ongoing clarity about their activities, roles and goals, is crucial to PPI's success. Funders, reviewers and regulators should recognise the value of preapplication PPI and allocate further resources to it. They should also consider whether PPI plans in grant applications match a trial's distinct needs. Monitoring and reporting PPI before, during and after trials will help the research community to optimise PPI, although the need for ongoing flexibility in implementing PPI should also be recognised.

SUBMITTER: Buck D

PROVIDER: S-EPMC4256646 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Publications

From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials.

Buck Deborah D Gamble Carrol C Dudley Louise L Preston Jennifer J Hanley Bec B Williamson Paula R PR Young Bridget B

BMJ open 20141204 12

<h4>Unlabelled</h4>: Patient and public involvement (PPI) in research is increasingly required, although evidence to inform its implementation is limited.<h4>Objective</h4>Inform the evidence base by describing how plans for PPI were implemented within clinical trials and identifying the challenges and lessons learnt by research teams.<h4>Methods</h4>We compared PPI plans extracted from clinical trial grant applications (funded by the National Institute for Health Research Health Technology Asse ...[more]

PMID: 25475243

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Project description:ObjectiveClinical trials and studies in intensive care units (ICUs) have complex consent processes and often encounter problems in recruiting patients. By interviewing research team members about the challenges in critical care research, we aimed to identify strategies to enhance recruitment and consent to ICU studies.MethodsSemistructured interviews with UK-based researchers (N=17) and patient-public involvement (PPI) contributors (N=8) with experience of ICU studies. Analysis of transcripts of audio-recorded interviews drew on thematic approaches.ResultsSeven themes were identified. Participants emphasised the need for substitute decision-making processes in critical care studies, yet some researchers reported that research ethics committees (RECs) were reluctant to approve such processes. Researchers spoke about the potential benefits of research without prior consent (RWPC) for studies with narrow recruitment windows but believed RECs would not approve them. Participants indicated that the activity of PPI contributors was limited in critical care studies, though researchers who had involved PPI contributors more extensively were clear that their input when designing consent processes was important. Researchers and PPI contributors pointed to resource and staffing limitations as barriers to patient recruitment. Researchers varied in whether and how they used professional consultees as substitute decision-makers, in whether they approached families by telephone to discuss research and in whether they disclosed details of research participation to bereaved relatives.ConclusionCritical care research could benefit from RECs having expertise in consent processes that are suited to this setting, better staffing at research sites, more extensive PPI and an evidence base on stakeholder perspectives on critical care research processes. Guidance on professional consultee processes, telephoning relatives to discuss research, RWPC and disclosure of research participation to bereaved relatives could help to harmonise practice in these areas and enhance recruitment and consent to critical care studies.

Project description:Plain language summaryResearch should benefit society at large. Involving citizens those who are affected by research may not only increase the quality, but can also push research towards generating greater societal benefits and relevant outcomes for citizens. Including citizens in research also has ethical implications, which necessitate structured guidance on 'how to' meaningfully involve them. In our project, we invited a multi-stakeholder group consisting of researchers from multiple disciplines, citizen scientists, youth and patient advocates to co-create a guide on 'how to' meaningfully involve citizens in research. In five consecutive workshops, we discussed how the characteristics of interactions between researchers and citizens (e.g., building trustful relationships and communication) and what a possible project steering structure enabling meaningful public involvement in research could look like. As a result of these workshops, the PPIE 'How to' Guide for Researchers was developed to support the implementation of 'Patient and Public Involvement and Engagement' (PPIE) activities and informed a PPIE Implementation Programme funding public involvement activities in Austria.AbstractInvolving citizens in research is not widely utilised across research disciplines and countries. It requires the readiness of researchers and their organisations as well as guides on 'how to' successfully involve citizens in a meaningful way. Including the patient and citizen voice in research activities has been most frequently demonstrated in health research, however, is implemented along various degrees of involvement - from passively receiving information about science to actively involving the citizens in steering projects and research activities. In this commentary, we aim to report a multi-stakeholder co-creation process developing 'Patient and Public Involvement and Engagement' (PPIE) activities across disciplines to provide guidance for researchers and the public. We use Ludwig Boltzmann Society's (LBG) organisational framework as a case study, hence it consists of research institutes ranging from the life sciences to humanities and therefore represents a well-suited research environment for this endeavour. In a co-creation approach - to accomplish a shared understanding of public involvement in research among different stakeholders - a multi-stakeholder group comprising 11 researchers from natural sciences, life sciences, social sciences and humanities, and 13 citizens (such as patient advocates, young people and citizen scientists) were involved. In five consecutive workshops, we co-developed the nature of interactions between citizens and researchers, as well as governance structures enabling meaningful involvement in research. The workshops' content was informed by an initial literature review. As a result of this process, the PPIE 'How to' Guide for Researchers was developed to support the implementation of involvement activities in their research projects according to the public involvement principles. These principles informed assessment criteria for the newly established PPIE Implementation Programme at LBG. It provides funding and support for public involvement activities in research to embed a sustainable and meaningful implementation of public involvement activities in Austria.

Project description:ObjectivesThe Plutocratic Proposal is a novel method of funding early phase clinical trials where a single donor funds the entire trial and in so doing secures a place on it. The aim of this study was to identify and explore concerns that may be raised by UK research ethics committees (RECs) when reviewing clinical trials funded in this way.DesignEmpirical ethics combining ethical analysis and qualitative data from three focus groups held online using Frith's symbiotic approach. Data were analysed using inductive thematic approach informed by the study aims and ethical analysis.Participants22 participants were recruited: 8 research patient public involvement group members, 7 REC chairs and 7 clinical researchers. All were based in the UK.ResultsWith one exception, participants thought the Plutocratic Proposal may be 'all things considered' acceptable, providing their concerns were met, primary of which was upholding scientific integrity. Other concerns discussed related to the acceptability of the donor securing a place on the trial including: whether this was an unfair distribution of benefits, disclosing the identity of the donor as the funder, protecting the donor from exploitation and funding a single study with multiple donors on the same terms. Some misgivings fell outside the usual REC purview: detrimental impact of donors of bad character, establishing the trustworthiness of the matching agency and its processes and optimising research funding and resources. Despite their concerns, participants recognised that because the donor funds the whole trial, others would also potentially benefit from participating.ConclusionsWe identified concerns about the Plutocratic Proposal. UK RECs may be open to approving studies if these can be addressed. Existing governance processes will do some of this work, but additional REC guidance, particularly in relation to donors securing a place on the trial, may be necessary to help RECs navigate ethical concerns consistently.

Project description:BackgroundPatient and public involvement (PPI) in health research may improve both the relevance and quality of the research. There is however a lack of research investigating the experiences, attitudes and barriers towards PPI in clinical research in Norway. The Norwegian Clinical Research Infrastructure Network therefore conducted a survey among researchers and PPI contributors aiming to investigate experiences with PPI and identify current challenges for successful involvement.MethodsTwo survey questionnaires were developed and distributed in October and November 2021. The survey targeting 1185 researchers was distributed from the research administrative system in the Regional Health Trusts. The survey targeting PPI contributors was distributed through Norwegian patient organisations, regional and national competence centers.ResultsThe response rate was 30% among researchers and was unobtainable from PPI contributors due to the survey distribution strategy. PPI was most frequently used in the planning and conduct of the studies, and less utilized in dissemination and implementation of results. Both researchers and user representatives were generally positive to PPI, and agreed that PPI might be more useful in clinical research than in underpinning research. Researchers and PPI contributors who reported that roles and expectations were clarified in advance, were more likely to experience a common understanding of roles and responsibilities in the research project. Both groups pointed to the importance of earmarked funding for PPI activities. There was a demand for a closer collaboration between researchers and patient organisations to develop accessible tools and effective models for PPI in health research.ConclusionsSurveys among clinical researchers and PPI contributors indicate overall positive attitudes towards PPI in clinical research. However, more resources, such as budget, time, and accessible tools, are needed. Clarifying roles and expectations, and creating new PPI models under resource constraints can enhance its effectiveness. PPI is underutilized in disseminating and implementing research results, presenting an opportunity for improving healthcare outcomes.

Project description:BackgroundFundamental to the success of clinical research that involves human participants is the quality of the data that is generated. To ensure data quality, clinical trials must comply with the Good Clinical Practice guideline which recommends data monitoring. To date, the guideline is broad, requires technology for enforcement, follows strict industry standards, mostly designed for drug-registration trials and based on informal consensus. It is also unknown what challenges clinical trials and researchers face in implementing data monitoring procedures. Thus, this study aimed to describe researcher experiences with data quality monitoring in clinical trials.MethodsWe conducted semi-structured telephone interviews following a guided-phenomenological approach. Participants were recruited from the Australian and New Zealand Clinical Trials Registry and were researchers affiliated with a listed clinical study. Each transcript was analysed with inductive thematic analysis before thematic categorisation of themes from all transcripts. Primary, secondary and subthemes were categorised according to the emerging relationships.ResultsData saturation were reached after interviewing seven participants. Five primary themes, two secondary themes and 21 subthemes in relation to data quality monitoring emerged from the data. The five primary themes included: education and training, ways of working, working with technology, working with data, and working within regulatory requirements. The primary theme 'education and training' influenced the other four primary themes. While 'working with technology' influenced the 'way of working'. All other themes had reciprocal relationships. There was no relationship reported between 'working within regulatory requirements' and 'working with technology'. The researchers experienced challenges in meeting regulatory requirements, using technology and fostering working relationships for data quality monitoring.ConclusionClinical trials implemented a variety of data quality monitoring procedures tailored to their situation and study context. Standardised frameworks that are accessible to all types of clinical trials are needed with an emphasis on education and training.

Project description:BackgroundSmartphones are being increasingly used for research owing to their multifunctionality and flexibility, and crowdsourced research using smartphone applications (apps) is effective in the early detection and management of chronic diseases. We developed the AllerSearch app to gather real-world data on individual subjective symptoms and lifestyle factors related to hay fever. This study established a foundation for interactive research by adopting novel, diverse perspectives accrued through implementing the principles of patient and public involvement (PPI) in the development of our app.MethodsPatients and members of the public with a history or family history of hay fever were recruited from November 2019 to December 2021 through a dedicated website, social networking services, and web briefing according to the PPI Guidebook 2019 by the Japan Agency for Medical Research and Development. Nine opinion exchange meetings were held from February 2020 to December 2021 to collect opinions and suggestions for updating the app. After each meeting, interactive evaluations from PPI contributors and researchers were collected. The compiled suggestions were then incorporated into the app, establishing an active feedback loop fed by the consistently interactive infrastructure.ResultsFour PPI contributors (one man and three women) were recruited, and 93 items were added/changed in the in-app survey questionnaire in accordance with discussions from the exchange meetings. The exchange meetings emphasized an atmosphere and opportunity for participants to speak up, ensuring frequent opportunities for them to contribute to the research. In March 2020, a public website was created to display real-time outcomes of the number of participants and users' hay-fever-preventative behaviors. In August 2020, a new PPI-implemented AllerSearch app was released.ConclusionsThis study marks the first research on clinical smartphone apps for hay fever in Japan that implements PPI throughout its timeline from research and development to the publication of research results. Taking advantage of the distinct perspectives offered by PPI contributors, a step was taken toward actualizing a foundation for an interactive research environment. These results should promote future PPI research and foster the establishment of a social construct that enables PPI efforts in various fields.

Dataset Information

From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials.

Unlabelled

Objective

Methods

Results

Conclusions

Publications

From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials.

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