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

ABSTRACT: Despite 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.To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials.A modified Delphi process including a two round online survey and a stakeholder consensus meeting.In 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.Round 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.The 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.

SUBMITTER: Kearney A

PROVIDER: S-EPMC5689224 | biostudies-other | 2017 Dec

REPOSITORIES: biostudies-other

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

Kearney Anna A Williamson Paula P Young Bridget B Bagley Heather H Gamble Carrol C Denegri Simon S Muir Delia D Simon Natalie A NA Thomas Stephen S Elliot Jim T JT Bulbeck Helen H Crocker Joanna C JC Planner Claire C Vale Claire C Clarke Mike M Sprosen Tim T Woolfall Kerry K

Health expectations : an international journal of public participation in health care and health policy 20170615 6

<h4>Background</h4>Despite 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.<h4>Objective</h4>To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials.<h4>Design</h4>A modified Delphi process including a two round online survey and a stakeholder consensus meeting.<h4>Participants< ...[more]

PMID: 28618076

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Project description:IntroductionThere is currently limited guidance for researchers on Patient and Public Involvement (PPI) for preclinical spinal cord research, leading to uncertainty about design and implementation. This study aimed to develop evidence-informed principles to support preclinical spinal cord researchers to incorporate PPI into their research.MethodsThis study used a modified Delphi method with the aim of establishing consensus on a set of principles for PPI in spinal cord research. Thirty-eight stakeholders including researchers, clinicians and people living with spinal cord injury took part in the expert panel. Participants were asked to rate their agreement with a series of statements relating to PPI in preclinical spinal cord research over two rounds. As part of Round 2, they were also asked to rate statements as essential or desirable.ResultsThirty-eight statements were included in Round 1, after which five statements were amended and two additional statements were added. After Round 2, consensus (> 75% agreement) was reached for a total of 27 principles, with 13 rated as essential and 14 rated as desirable. The principles with highest agreement related to diversity in representation among PPI contributors, clarity of the purpose of PPI and effective communication.ConclusionThis research developed a previously unavailable set of evidence-informed principles to inform PPI in preclinical spinal cord research. These principles provide guidance for researchers seeking to conduct PPI in preclinical spinal cord research and may also inform PPI in other preclinical disciplines.Patient and public involvement statementThis study was conducted as part of a project aiming to develop PPI in preclinical spinal cord injury research associated with an ongoing research collaboration funded by the Irish Rugby Football Union Charitable Trust (IRFU CT) and the Science Foundation Ireland Centre for Advanced Materials and BioEngineering Research (SFI AMBER), with research conducted by the Tissue Engineering Research Group (TERG) at the RCSI University of Medicine and Health Sciences. The project aims to develop an advanced biomaterials platform for spinal cord repair and includes a PPI Advisory Panel comprising researchers, clinicians and seriously injured rugby players to oversee the work of the project. PPI is included in this study through the involvement of members of the PPI Advisory Panel in the conceptualisation of this research, review of findings, identification of key points for discussion and preparation of the study manuscript as co-authors.

Project description:BackgroundStandard interpretations of the ethical principle of respect for persons have not incorporated the views and values of patients, especially patients from groups underrepresented in research. This limits the ability of research ethics scholarship, guidance, and oversight to support inclusive, patient-centered research. This study aimed to identify the practical approaches that patients in community-based settings value most for conveying respect in genomics research.MethodsWe conducted a 3-round, web-based survey using the modified Delphi technique to identify areas of agreement among English-speaking patients at primary care clinics in Washington State and Idaho who had a personal or family history of cancer. In Round 1, respondents rated the importance of 17 items, identified in prior qualitative work, for feeling respected. In Round 2, respondents re-rated each item after reviewing overall group ratings. In Round 3, respondents ranked a subset of the 8 most highly rated items. We calculated each item's mean and median rankings in Round 3 to identify which approaches were most important for feeling respected in research.ResultsForty-one patients consented to the survey, 21 (51%) completed Round 1, and 18 (86% of Round 1) completed each of Rounds 2 and 3. Two sets of rankings were excluded from analysis as speed of response suggested they had not completed the Round 3 ranking task. Respondents prioritized provision of study information to support decision-making (mean ranking 2.6 out of 8; median ranking 1.5) and interactions with research staff characterized by kindness, patience, and a lack of judgment (mean ranking 2.8; median ranking 2) as the most important approaches for conveying respect.ConclusionsInformed consent and interpersonal interactions are key ways that research participants experience respect. These can be supported by other approaches to respecting participants, especially when consent and/or direct interactions are infeasible. Future work should continue to engage with patients in community-based settings to identify best practices for research without consent and examine unique perspectives across clinical and demographic groups in different types of research.

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.

Project description:BackgroundDevelopments in digital health have the potential to transform the delivery of health and social care to help citizens manage their health. Currently, there is a lack of consensus about digital health research priorities in palliative care and a lack of theories about how these technologies might improve care outcomes. Therefore, it is important for health care leaders to identify innovations to ensure that an increasingly frail population has appropriate access to palliative care services. Consequently, it is important to articulate research priorities as the first step in determining how finite resources should be allocated to a field saturated with rapidly developing innovation.ObjectiveThe aim of this study is to identify research priority areas for digital health in palliative care.MethodsWe selected digital health trends, most relevant to palliative care, from a list of emerging trends reported by a leading institute of quantitative futurists. We conducted 2 rounds of the Delphi questionnaire, followed by a consensus meeting and public engagement workshop to establish a final consensus on research priorities for digital technology in palliative care. We used the views of public representatives to gain their perspectives on the agreed priorities.ResultsA total of 103 experts (representing 11 countries) participated in the first Delphi round. Of the 103 experts, 55 (53.3%) participated in the second round. The final consensus meetings were attended by 10.7% (11/103) of the experts. We identified 16 priority areas, which involved many applications of technologies, including care for patients and caregivers, self-management and reporting of diseases, education and training, communication, care coordination, and research methodology. We summarized the priority areas into eight topics: big data, mobile devices, telehealth and telemedicine, virtual reality, artificial intelligence, smart home, biotechnology, and digital legacy.ConclusionsThe priorities identified in this study represent a wide range of important emerging areas in the fields of digital health, personalized medicine, and data science. Human-centered design and robust governance systems should be considered in future research. It is important that the risks of using these technologies in palliative care are properly addressed to ensure that these tools are used meaningfully, wisely, and safely and do not cause unintentional harm.

Project description:ObjectivesThe increase in global wildland fire activity has accelerated the urgency to understand health risks associated with wildland fire suppression. The aim of this project was to identify occupational health research priorities for wildland firefighters and related personnel.DesignIn order to identify, rank and rate health research priorities, we followed a modified Delphi approach. Data collection involved a two-stage online survey followed by semi-structured interviews.SettingBritish Columbia, Canada.ParticipantsParticipants included any current or past wildland firefighter or individuals engaged in related roles. There were 132 respondents to the first survey. Responses to the first survey were analysed to produce 10 research topics which were ranked by 75 participants in the second survey (response rate: 84%).Primary and secondary outcome measuresThe primary outcome was the identification, ranking and level of agreement of research priorities through a two-round online survey. We contextualised these findings through deductive and inductive qualitative content analysis of semi-structured interviews.ResultsThe most important research priorities identified were (% consensus): effects of smoke inhalation on respiratory health (89%), fatigue and sleep (80%), mental health (78%), stress (76%) and long-term risk of disease (67%). Interviews were completed with 14 individuals. Two main themes were developed from an inductive content analysis of interview transcripts: (1) understanding the dynamic risk environment; and (2) organisational fit of mitigation strategies.ConclusionsParticipants expressed a general concern with the unknown mental and physical health impacts of their jobs, including the long-term risk of morbidity and mortality. Future research must address knowledge gaps in our understanding of the health impacts of wildland fire and work to develop appropriate mitigation strategies while considering the needs of workers and unpredictable workplace environment.Trial registration numberOpen Science Framework, https://osf.io/ugz4s/.

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

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

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