Challenges of developing, conducting, analysing and reporting a COVID-19 study as the COVID-19 pandemic unfolds: an online co-autoethnographic study

ObjectivesTo capture the complexities and unique experience of a newly formed multidisciplinary and multicentre research team developing and deploying a COVID-19 study and to identify lessons learnt.DesignCo-autoethnographic study.SettingStaff at two UK academic institutions, a national charity and two major UK hospitals.ParticipantsResearchers, clinicians, academics, statisticians and analysts, patient and public involvement representatives and national charity.MethodsThe sampling frame was any content discussed or shared between research team members (emails, meeting minutes, etc), standard observational dimensions and reflective interviews with team members. Data were thematically analysed.ResultsData from 34 meetings and >50 emails between 17 March and 5 August 2020 were analysed. The analysis yielded seven themes with ‘Managing our stress’ as an overarching theme.ConclusionsMutual respect, flexibility and genuine belief that team members are doing the best they can under the circumstances are essential for completing a time-consuming study, requiring a rapid response during a pandemic. Acknowledging and managing stress and a shared purpose can moderate many barriers, such as the lack of face-to-face interactions, leading to effective team working.

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PARE0007 PATIENT AND PUBLIC INVOLVEMENT IN CLINICAL TRIAL DESIGN

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.145 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1289.1-1290

Author(s):

S. De Souza ◽

R. Williams ◽

E. Johansson ◽

C. Zabalan ◽

T. Esterine ◽

...

Keyword(s):

At Risk ◽

Lived Experience ◽

Public Involvement ◽

Clinical Trial Design ◽

Patient And Public Involvement ◽

Face To Face ◽

Before And After ◽

Extensive Consultation ◽

New Perspective ◽

The Eu

Background:Patient and public involvement (PPI) is gaining increasing recognition as important in ensuring research is relevant and acceptable to participants. Rheuma Tolerance for Cure (RTCure) is a 5 year international collaboration between academia and industry; focusing on earlier detection and prevention of rheumatoid arthritis (RA) through the use of immune-tolerising treatments.Objectives:To bring lived experience and insight into scientific discussions; and to evolve collaboration between lay representatives and academia/industry.Methods:9 Patient Research Partners (PRPs) from 5 European countries were recruited via the EULAR PARE Network and institutions within the RTCure Consortium (8 PRPs with RA and 1 ‘at risk’). They were asked to enter into a legal agreement with the Consortium. PRPs participated in teleconferences (TCs) and were invited to attend face-to-face (F2F) meetings at least annually. Requests for input/feedback were sent from researchers to PRPs via the project’s Patient Engagement Expert [SK].Results:PRP involvement has given researchers and industry partners a new perspective on patient priorities, and focused thought on the ethics of recruitment for and participation in clinical trials of people ‘at risk’ of developing RA. PRPs have helped define the target populations, given their thoughts on what types of treatments are acceptable to people ‘at risk’ and have aided the development of a survey (sent to EULAR PARE members) regarding the use of animal models in biomedical research. Positive informal feedback has been received from researchers and industry regarding the contribution of PRPs to the ongoing project (formal evaluation of PPI in RTCure will be carried out in 2020 and at the project end in 2022).Challenges:Legal agreements- Many PRPs refused to sign the Consortium’s complex PRP Agreement; feeling it unnecessary, incomprehensible and inequitable. After extensive consultation with various parties (including EULAR and the Innovative Medicines Initiative) no similar contract was found. Views for its requirement even varied between legal experts. After 2 years of intense discussion, a simple non-disclosure agreement was agreed upon. Ideally any contract, if required, should be approved prior to project onset.Meeting logistics- Other improvements identified were to locate the meeting venue and accommodation on the same site to minimise travel, and to make it easier for PRPs to take breaks when required. This also facilitates informal discussions and patient inclusivity. We now have agreed a policy to fund PRPs extra nights before and after meetings, and to bring a carer if needed.Enabling understanding– Future annual meetings will start with a F2F meeting between PRPs and Work Package Leads. Researchers will be encouraged to start presentations with a summary slide in lay language. Additionally, an RTCure Glossary is in development.Enabling participation– SK will provide monthly project updates and PRP TCs will be held in the evening (as some PRPs remain employed). PRPs will be invited to all project TCs and F2F meetings. Recruitment is underway to increase the number of ‘at risk’ PRPs as their viewpoint is vital to this study.Conclusion:Currently PPI in RTCure is an ongoing mutual learning process. Universal guidance regarding what types of contracts are needed for PPI would be useful. Communication, trust and fruitful discussions have evolved through F2F meetings (both formal and informal) between PRPs, academia and industry. It is important that all parties can be open with each other in order to make PPI more meaningful.Acknowledgments:This work has received support from the EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking RTCure grant number 777357.Disclosure of Interests:Savia de Souza: None declared, Ruth Williams: None declared, Eva Johansson: None declared, Codruta Zabalan: None declared, Tom Esterine: None declared, Margôt Bakkers: None declared, Wolfgang Roth: None declared, Neil Mc Carthy: None declared, Meryll Blake: None declared, Susanne Karlfeldt: None declared, Martina Johannesson: None declared, Karim Raza Grant/research support from: KR has received research funding from AbbVie and Pfizer, Consultant of: KR has received honoraria and/or consultancy fees from AbbVie, Sanofi, Lilly, Bristol-Myers Squibb, UCB, Pfizer, Janssen and Roche Chugai, Speakers bureau: KR has received honoraria and/or consultancy fees from AbbVie, Sanofi, Lilly, Bristol-Myers Squibb, UCB, Pfizer, Janssen and Roche Chugai

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Reaching consensus on reporting patient and public involvement (PPI) in research: methods and lessons learned from the development of reporting guidelines

BMJ Open ◽

10.1136/bmjopen-2017-016948 ◽

2017 ◽

Vol 7 (10) ◽

pp. e016948 ◽

Cited By ~ 12

Author(s):

Jo Brett ◽

Sophie Staniszewska ◽

Iveta Simera ◽

Kate Seers ◽

Carole Mockford ◽

...

Keyword(s):

Public Involvement ◽

Evidence Base ◽

Patient And Public Involvement ◽

Lessons Learned ◽

Reporting Guidelines ◽

Consensus Development ◽

Face To Face ◽

Three Phase ◽

Health And Social Care ◽

The Impact

IntroductionPatient and public involvement (PPI) is inconsistently reported in health and social care research. Improving the quality of how PPI is reported is critical in developing a higher quality evidence base to gain a better insight into the methods and impact of PPI. This paper describes the methods used to develop and gain consensus on guidelines for reporting PPI in research studies (updated version of the Guidance for Reporting Patient and Public Involvement (GRIPP2)).MethodsThere were three key stages in the development of GRIPP2: identification of key items for the guideline from systematic review evidence of the impact of PPI on health research and health services, a three-phase online Delphi survey with a diverse sample of experts in PPI to gain consensus on included items and a face-to-face consensus meeting to finalise and reach definitive agreement on GRIPP2. Challenges and lessons learnt during the development of the reporting guidelines are reported.DiscussionThe process of reaching consensus is vital within the development of guidelines and policy directions, although debate around how best to reach consensus is still needed. This paper discusses the critical stages of consensus development as applied to the development of consensus for GRIPP2 and discusses the benefits and challenges of consensus development.

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THE STUDY OF AGING A SEARCH FOR MEANINGFUL PATIENT AND PUBLIC INVOLVEMENT IN GERONTOLOGICAL QUALITATIVE DATA ANALYSIS

Innovation in Aging ◽

10.1093/geroni/igz038.2953 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S802-S803

Author(s):

Barbara Hanratty ◽

Rachel Stocker ◽

Katie Brittain

Keyword(s):

Data Analysis ◽

Research Team ◽

Qualitative Data ◽

Public Involvement ◽

Long Term Care ◽

Patient And Public Involvement ◽

Term Care ◽

The Public ◽

Care Research

Abstract Patients and the public are involved in health and social care research more than ever before. Much effort has been put into developing patient and public involvement (PPI), and promoting co-production of research with patients and the public. Yet there is little guidance for researchers on how to involve PPI partners in the research process, or how involvement can be judged as meaningful. This presentation has its origins in the attempts of one research team to question and navigate a way of involving PPI in long term care research. In this presentation, we describe our model of collaborative qualitative data analysis with PPI partners, in a study exploring primary care services for older adults living in long-term care facilities in England. Anonymised interview transcript excerpts were presented in written, audio, and role-play format to our PPI partners. PPI partners derived meaning from interview data, identifying, confirming and critiquing emerging themes. Their input at this critical stage of the study deepened our initial analysis and prompted the research team to new and different interpretations of the data. This talk addresses ways of engaging PPI partners in innovative ways during data analysis, and offers other researchers some questions, challenges and potential principles for effective practice. We conclude that in areas such as long term care, with multiple stakeholders and a dynamic environment, effective PPI may be flexible, messy and difficult to define.

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Time Pressure and the Extent of Homophily in the Workplace Communications of A/E Design Teams

10.25219/epoj.2021.00109 ◽

2021 ◽

Vol 10 (2) ◽

Author(s):

Lindsey Walker ◽

Bryan Franz

Keyword(s):

Time Pressure ◽

Building Design ◽

Physical Distance ◽

Project Teams ◽

Communication Media ◽

Project Schedule ◽

Email Communication ◽

Team Members ◽

Face To Face ◽

Team Working

Workplace collaboration depends on communication and is critical in building design. For large, highly diverse teams, such as those found in architecture and engineering (A/E) who work under timebased deadlines, homophily—or the tendency to seek interactions with others of similar backgrounds and values—can play a role in how individuals communicate. Homophily is potentially damaging to teams that must coordinate information from a diverse membership, since communication may become less likely to occur across disciplines. Therefore, this research examines the extent to which a sampled A/E team exhibits homophily in their information exchanges across multiple communication media, when under the moderating effect of two different levels of time pressure. The study uses a social network analysis of the communication patterns in an 18-member studio team working for a national A/E firm located in the southeastern United States. The results show some evidence of homophily as a predictor of information exchanges when controlling for the hierarchical ties within the studio team and the physical distance between its members in the office. In a low time pressure work environment, face-to-face communication was more likely when members were of the same gender. This effect was not present when the team was under high time pressure, where face-to-face interactions were instead more likely between members of the same discipline. Homophily in phone communication was found in the generational similarity of team members, regardless of time pressure. There was little evidence that homophily was a predictor of email communication. These results have implications for the design of studio workplaces that support information-rich interactions, the assignment of individual designers to project teams that are more likely to interact with co-workers from different backgrounds, and organizational policy regarding the use of specific communication media based on the project schedule and time pressure.

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Patient and public involvement in research: from tokenistic box ticking to valued team members

BMC Medicine ◽

10.1186/s12916-020-01544-7 ◽

2020 ◽

Vol 18 (1) ◽

Author(s):

Tracy Jackson ◽

Hilary Pinnock ◽

Su May Liew ◽

Elsie Horne ◽

Elisabeth Ehrlich ◽

...

Keyword(s):

Public Involvement ◽

Patient And Public Involvement ◽

Team Members

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Achieving effective patient and public involvement in international clinical trials in neurology

Neurology Clinical Practice ◽

10.1212/cpj.0000000000000739 ◽

2019 ◽

Vol 10 (3) ◽

pp. 265-272 ◽

Cited By ~ 1

Author(s):

Emma C. Tallantyre ◽

Nikos Evangelou ◽

Clare Bale ◽

Burhan Z. Chaudhry ◽

Emma H. Gray ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Randomized Controlled Trials ◽

Research Team ◽

Public Involvement ◽

Patient And Public Involvement ◽

Controlled Trials ◽

Framework Analysis ◽

Randomized Controlled ◽

Structured Approach

There is a growing need for patient and public involvement (PPI) to inform the way that research is developed and performed. International randomized controlled trials are particularly likely to benefit from PPI, but guidance is lacking on how or when it should be incorporated. In this article, we describe the PPI process that occurred during the design and initiation of an international treatment clinical trial in MS. PPI was incorporated using a structured approach, aiming to minimize bias and achieve equivalence in study design, implementation, and interpretation. Methods included PPI representation within the study research team, and the use of focus groups, analyzed using thematic framework analysis. We report the outcomes of PPI and make recommendations on its use in other neurology clinical trials. By sharing our model for PPI, we aim to maximize effectiveness of future public involvement and to allow its effect to be better evaluated.

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ReseArch with Patient and Public invOlvement: a RealisT evaluation – the RAPPORT study

Health Services and Delivery Research ◽

10.3310/hsdr03380 ◽

2015 ◽

Vol 3 (38) ◽

pp. 1-176 ◽

Cited By ~ 81

Author(s):

Patricia Wilson ◽

Elspeth Mathie ◽

Julia Keenan ◽

Elaine McNeilly ◽

Claire Goodman ◽

...

Keyword(s):

Case Studies ◽

Study Design ◽

Research Team ◽

Public Involvement ◽

Research Process ◽

Patient And Public Involvement ◽

Realist Evaluation ◽

Research Network ◽

Normalisation Process Theory ◽

The Impact

BackgroundPatient and public involvement (PPI) is a prerequisite for many funding bodies and NHS research ethics approval. PPI in research is defined as research carried out with or by the public rather than to, about or for them. While the benefits of PPI have been widely discussed, there is a lack of evidence on the impact and outcomes of PPI in research.ObjectivesTo determine the types of PPI in funded research, describe key processes, analyse the contextual and temporal dynamics of PPI and explore the experience of PPI in research for all those involved. Mechanisms contributing to the routine incorporation of PPI in the research process were assessed, the impact of PPI on research processes and outcomes evaluated, and barriers and enablers to effective PPI identified.DesignA three-staged realist evaluation drawing on Normalisation Process Theory to understand how far PPI was embedded within health-care research in six areas: diabetes mellitus, arthritis, cystic fibrosis, dementia, public health and learning disabilities. The first two stages comprised a scoping exercise and online survey to chief investigators to assess current PPI activity. The third stage consisted of case studies tracked over 18 months through interviews and document analysis. The research was conducted in four regions of England.ParticipantsNon-commercial studies currently running or completed within the previous 2 years eligible for adoption on the UK Clinical Research Network portfolio. A total of 129 case study participants included researchers and PPI representatives from 22 research studies, and representatives from funding bodies and PPI networks.ResultsIn the scoping 51% (n = 92) of studies had evidence of PPI and in the survey 79% (n = 80), with funder requirements and study design the strongest influence on the extent of PPI. There was little transparency about PPI in publicly accessible information. In case studies, context–mechanism–outcome configurations suggested that six salient actions were required for effective PPI. These were a clear purpose, role and structure for PPI; ensuring diversity; whole research team engagement with PPI; mutual understanding and trust between the researchers and lay representatives; ensuring opportunities for PPI throughout the research process; and reflecting on, appraising and evaluating PPI within a research study. PPI models included a ‘one-off’ model with limited PPI, a fully intertwined model in which PPI was fully embedded and an outreach model with lay representatives linking to broader communities. Enabling contexts included funder, topic/design, resources, research host, organisation of PPI and, most importantly, relationships. In some case studies, lack of coherence in defining PPI persisted, with evidence of a dual role of PPI representative/study participant. Evidence of PPI outcomes included changes to study design, improvements to recruitment materials and rates, and dissemination.ConclusionsSix salient actions were required for effective PPI and were characterised by a shared understanding of moral and methodological purposes of PPI, a key individual co-ordinating PPI, ensuring diversity, a research team positive about PPI input and fully engaged with it, based on relationships that were established and maintained over time, and PPI being evaluated in a proactive and systematic approach. Future work recommendations include exploring the impact of virtual PPI, cost analysis and economic evaluation of the different models of PPI, and a longer-term follow-up study of the outcomes of PPI on research findings and impact on services and clinical practice.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

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P074 Insights into creating a virtual patient and public involvement initiative

Rheumatology ◽

10.1093/rheumatology/keab247.072 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Eleanor Hawkins ◽

Tracy Hyndman ◽

Raj Amarnani ◽

James Kimpton ◽

Su-Ann Yeoh ◽

...

Keyword(s):

Biomedical Research ◽

Health Research ◽

Patient Involvement ◽

Public Involvement ◽

Patient And Public Involvement ◽

Research Centre ◽

Face To Face ◽

London Hospital ◽

University College ◽

University College London

Abstract Background/Aims Patient and public involvement (PPI) initiatives are important to ensure patient-centered research. However, traditional focus groups can present challenges including the recruitment and retention of patient partners. Additional challenges to patient involvement have also arisen due to the coronavirus pandemic (COVID-19). The University College London (UCL) Patient Partners in Rheumatology Research initiative has been developed to explore novel ways to boost patient involvement and foster an active collaboration between basic researchers and patient partners. Methods Two online surveys were designed to obtain information with regards to the expectations and practicalities of this initiative. One survey was sent to patients who had registered an interest in being patient partners and the other survey to rheumatology researchers at UCL and University College London Hospital (UCLH). Results We received responses from 25 researchers and 21 patients. The majority of patients who responded (71%) had not previously been involved in PPI. Most of the researchers (84%) had previously utilised PPI, however 20% of those had some difficulty accessing it. Most patients (86%) were interested in becoming a patient partner. Amongst those with reservations, one stated that “I don't think I have the qualifications to be involved with scientists and researchers”. Over half of patients (52%) were happy to participate in PPI more than five times a year and most researchers (84%) expressed that five times a year was acceptable. Patients favoured (52%) conducting PPI meetings after office hours (5-8pm) during the working week. Due to social restrictions because of COVID-19, we asked both patients and researchers their preferred mode of meeting. Both groups favoured a mixed (virtual and face to face) meeting arrangement (81% for patients and 68% for researchers). A third of patients (38%) expressed that they would need technical assistance accessing a virtual meeting. Almost all patients (95%) were happy to contribute to lay summary reviews remotely via email. Conclusion Based on the insights gained from the survey results, our PPI initiative meetings will be hosted in a hybrid virtual/face to face format. These will be held at a time and frequency that is convenient for the patient partners to increase participation across wider demographics. This survey has highlighted that we have to be mindful of certain patient perceptions of PPI which creates a barrier to patient involvement and that some individuals may require further support in accessing virtual meetings. By designing a PPI initiative that creatively addressed the needs of both the researchers and patient partners we hope to create a platform for productive dialogue and collaboration to ensure patient-centred research, despite the changes brought about by the COVID-19 pandemic. Disclosure E. Hawkins: Other; funded by National Institute of Health Research, Clinical Research Network. T. Hyndman: None. R. Amarnani: None. J. Kimpton: None. S. Yeoh: Other; University College London Hospital National Institute of Health Research Biomedical Research Centre, UCLH Charities, Royal College of Physicians and Rosetrees Trust. M. Castelino: Other; University College London Hospitals National Institute for Health Research Biomedical Research Centre.

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Formalising the induction of patient and public involvement contributors on trial oversight committees

Research Involvement and Engagement ◽

10.1186/s40900-021-00269-y ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Emily C. Pickering ◽

Bec Hanley ◽

Philip Bell ◽

Jacqui Gath ◽

Patrick Hanlon ◽

...

Keyword(s):

Clinical Trials ◽

Public Involvement ◽

Patient And Public Involvement ◽

General Role ◽

Face To Face ◽

Full Picture ◽

Clinical Trials Unit ◽

Research Organisations ◽

Trial Oversight

Abstract Background Clinical Trials Units are encouraged to integrate Patient and Public Involvement (PPI) into all aspects of trial design, running and oversight. This research explored the induction and training of PPI Contributors joining trial oversight committees and was used to update the Medical Research Council Clinical Trials Unit at University College London’s (MRC CTU at UCL) induction pack for new PPI Contributors. Methods Published and unpublished materials provided by other CTUs and research organisations on training for PPI Contributors on oversight committees were reviewed, with themes then triangulated to identify the most common topics covered in induction training. A face-to-face workshop with PPI Contributors from the MRC CTU at UCL reviewed a draft updated Induction Pack. Findings from these discussions were incorporated into a revised induction pack which was then re-reviewed by the workshop attendees. Results No published literature on this subject was found. However, several common themes were identified from unpublished materials. Workshop attendees agreed with most of the themes suggested in the initial draft pack based on the literature search and also provided a number of additional topics for discussion. Conclusions There is very little consistency in the induction of PPI Contributors on oversight committees. Whilst most local guidance explains the general role of a PPI Contributor, more context and background of the particular trial needs to be provided to allow for adequate induction of new committee members. The Induction Pack created provides a framework upon which trial managers can build a full picture of their study.

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Google search data as a novel adjunct to patient and public involvement in rheumatology research

Rheumatology International ◽

10.1007/s00296-020-04723-0 ◽

2020 ◽

Author(s):

Mrinalini Dey ◽

Sizheng Steven Zhao

Keyword(s):

Focus Groups ◽

Public Involvement ◽

Cost Effective ◽

Patient And Public Involvement ◽

Future Research ◽

Face To Face ◽

Search Data ◽

Query Tool ◽

Public Views ◽

Google Search

Abstract Patient and public involvement is essential in the design and implementation of research studies to ensure research remains relevant and in line with public priorities. Public views on a given area of research may be sought via platforms such as focus groups or surveys. Here, we present the use of an openly available Google search data query tool, which may be used alongside traditional forms of patient and public involvement in research to highlight public perceptions and priorities. We used an online search query tool (“AnswerThePublic.com”) to explore public Google searches relating to “arthritis,” and an exemplar rheumatic disease, “rheumatoid arthritis.” The most common searches relating to these diseases included quality of life, treatment, prognosis, as well as impacts on life, including work. However, they also reveal concerns that may be more difficult to elicit in face-to-face focus groups, such as questions on alcohol consumption in arthritis, and impacts on mental health. Using public search engine data in research, alongside the important traditional methods of patient and public involvement, is a cost-effective and time-efficient method of gauging public views and concerns on a given topic. It may facilitate broad scoping searches of public priorities and help to guide future research questions.

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