Digital undergraduate medical education and patient and carer involvement: a rapid systematic review of current practice.

BACKGROUND: Involving patients and carers in medical students' learning aims to centralise the perspective of healthcare users and supports our future medical workforce in the development of key skills. Medical schools are increasingly using digital technology for teaching and it is timely to understand how to maintain patient and carer involvement in this context. METHODS: Ovid MEDLINE, Ovid EMBASE and medRxiv were searched in October 2020 and reference lists of key articles were hand searched. Eligible studies reported authentic patient or carer involvement in undergraduate medical education where technology was also used. Study quality was assessed by the Mixed Methods Appraisal Tool (MMAT). Levels of patient or carer involvement were assessed using Towle et al.'s (2010) taxonomy, from Level 1 (lowest level) to Level 6 (highest level). RESULTS: Twenty studies were included in this systematic review. In 70% of studies, patients and carers featured in video or web-based case scenarios with no interaction between healthcare users and students. The remaining 30% of studies reported real-time interactions between students and patients via remote clinical encounters. Digital teaching sessions involving patients or carers were perceived to be valuable by students and educators, and increased student engagement, patient-centred attitudes, clinical knowledge, and communication skills. No studies reported the perspective of patients or carers. DISCUSSION: Digital technology has not yet driven higher levels of patient and carer involvement in medical training. "Live" interactions between students and patients are becoming more common but challenges need addressing to ensure positive experiences for all involved. Future teaching should enhance the role of patients and carers in medical education and support them to overcome any potential barriers to doing so remotely.

The impact of patient and public involvement on COVID-19 immunology research: experiences from the UK Coronavirus Immunology Consortium.

BACKGROUND: Patient and Public Involvement (PPI) in clinical trial research is recognised as relevant but the active involvement of patients and the public in basic science or laboratory-based research is seen as more challenging and not often reported. PPI within the UK Coronavirus Immunology Consortium (UK-CIC), a translational research project aimed at tackling some of the key questions about the immune system's response to SARS-CoV-2, is an example of overcoming negative perceptions and obstacles. Given the widespread impact of COVID-19, it was important to consider the impact of UK-CIC research on patients and the public throughout, and the PPI panel were an integral part of the consortium. FINDINGS: Building in funding for a PPI panel to value involvement and ensuring effective expert administrative support and management of PPI were crucial to success. Facilitating relationships and quality interactions between public contributors and researchers required time and commitment to the project from all parties. Through creating a platform and open space to explore diverse views and a wide range of perspectives, PPI was able to influence researchers' ways of thinking about their research and impact future research questions about COVID-19 immunology. Moreover, there was long-term impact from the involvement of the PPI panel in COVID-19 research and their value was reflected in invitations to contribute to additional immunology projects. CONCLUSION: The ability to conduct meaningful PPI with basic immunology research has been shown possible through the UK-CIC in the context of the fast-moving COVID-19 pandemic. The UK-CIC project has laid the foundations for PPI in immunology and this should now be built upon for the advantage of future basic scientific research; PPI can impact greatly on laboratory-based research when given the opportunity to do so.

Patient public involvement (PPI) in health literacy research: Engagement of adults with literacy needs in the co-creation of a hospital-based health literacy plan.

BACKGROUND: People with literacy needs can experience many challenges in accessing, understanding and using health services and health information. Such challenges can adversely impact patient-provider interactions and ultimately, health outcomes. Healthcare providers need to be aware of health literacy (HL) to address the demands of healthcare systems, improve their interactions with communities and patients and promote patient engagement for improved health outcomes. METHODS: This paper reports on a process of patient and public involvement (PPI) with participants in an adult literacy programme acting as PPI contributors to identify priority areas for a local hospital HL action plan and to develop a protocol for a PPI process with other groups. A qualitative community-based participatory research study design informed by principles of PPI was undertaken, drawing on the tools of participatory and visual methods, open discussion and workshop format to facilitate a process of co-creation. Three workshops with six PPI contributors took place to identify issues to be included in the hospital action plan. PPI contributors identified issues and grouped these into priority areas using discussion and ranking procedures. RESULTS: Key areas prioritised for HL action by the PPI contributors were: verbal communication, emphasising the patient's right to understand, and improved understanding of medication use. These were incorporated into the action plan. The workshop format and process were deemed acceptable to the group and input on improvements will be incorporated into further work in this area. CONCLUSION: PPI acts as a lever in the knowledge translation process. Genuine engagement with service users can meaningfully contribute to relevant and sustainable changes to services as well as foster the empowerment of service users. PATIENT OR PUBLIC CONTRIBUTION: Members of the public with literacy needs actively participated in the co-creation of a HL action plan for a local hospital and in the development of a protocol for a patient and public process for HL research.

To summarise the approach to and findings of the PPIE undertaken as part of a programme of secondary research with a vulnerable, hard to reach population during the COVID-19 pandemic.

BACKGROUND: Public and patient involvement and engagement (PPIE) is an important part of research. The inclusion of PPIE in research is becoming more widespread, however, there are some areas where it is still uncommon. For example, undertaking PPIE in secondary analysis projects is uncommon and PPIE with difficult to reach populations and vulnerable groups can be seen as being too difficult to facilitate. The aim was to summarise the approach to and findings of the PPIE undertaken as part of a programme of secondary analysis with a vulnerable, hard to reach population; residents of residential care facilities (RCFs), during the COVID-19 pandemic. METHODS: As part of a project to develop a publically available database of statutory notifications of adverse events from RCFs in Ireland, residents (n = 9) from RCFs for older people and people with disability were telephone interviewed. Residents were engaged through gatekeepers and posted participant information and consent forms. Themes were identified using content analyses of interview notes. RESULTS: Three parent themes were identified, each with two subthemes: privacy concerns, enthusiasm and dissemination of research findings. Residents highlighted the importance that no personal information be shared in the database. Once data were anonymized, residents thought that the database should be published and shared. Residents reported being happy about research being undertaken using the data and thought that publishing the database would help inform the public about RCFs. Completing a PPIE project with a vulnerable group during the global COVID-19 pandemic required planning and resources. Resources included finances, time and expertise. CONCLUSIONS: The involvement of residents informed the data inclusion in the published database and the approach taken in the protection of personal data. Enthusiasm for publication and research using the database by residents encouraged the developers as it was considered something that was wanted by residents. The benefits of PPIE can be achieved with vulnerable groups during unprecedented times with the appropriate planning. It requires dedication of time, finances and expertise. Overcoming the obstacles was achievable and worthwhile. The approach outlined can be used as an example to support PPIE in secondary analysis projects and or with vulnerable groups.

When doing research, it is important to involve the people that the research is going to impact. Research projects are increasingly including this involvement, however, there are some areas of research where it is not yet commonplace. For example, when undertaking projects with existing data or when the people of interest are considered a difficult to reach or vulnerable group. The LENS project (LEarning from Notifications in Social care) is a research project that developed and published a database using existing data on safety incidents in care homes. We carried out a consultation with people living in care homes as part of this project. People were asked for their input on the development of the database and the research that was being carried out on it. This work was completed during the COVID-19 pandemic and, as such, the people giving input were considered a vulnerable group. The people living in care homes were concerned about personal details being included in the database. Once they were reassured that no personal information would be included they were supportive of the database being made public. They also offered ideas about how the research that used the database could teach people working and living in care homes. The article describes how the researchers engaged the people and what was needed to achieve this. The article shows that involving people from vulnerable groups and in research relating to existing data, adds value even though there are obstacles to overcome. It is summarised here as an example for researchers undertaking similar work.

Understanding who is and isn't involved and engaged in health research: capturing and analysing demographic data to diversify patient and public involvement and engagement.

BACKGROUND: Patient and public involvement and engagement (PPIE) can improve the relevance, quality, ethics and impact of research thus contributing to high quality research. Currently in the UK, people who get involved in research tend to be aged 61 years or above, White and female. Calls for greater diversity and inclusion in PPIE have become more urgent especially since the COVID-19 pandemic, so that research can better address health inequalities and be relevant for all sectors of society. Yet, there are currently no routine systems or requirements to collect or analyse the demographics of people who get involved in health research in the UK. The aim of this study was to develop to capture and analyse the characteristics of who does and doesn't take part in patient and public involvement and engagement (PPIE) activities. METHODS: As part of its strategic focus on diversity and inclusion, Vocal developed a questionnaire to assess the demographics of people taking part in its PPIE activities. Vocal is a non-profit organisation which supports PPIE in health research across the region of Greater Manchester in England. The questionnaire was implemented across Vocal activities between December 2018 and March 2022. In that time. Vocal was working with approximately 935 public contributors. 329 responses were received: a return rate of 29.3%. Analysis of findings and comparison against local population demographic data, and available national data related to public contributors to health research, was performed. RESULTS: Results show that it is feasible to assess the demographics of people who take part in PPIE activities, through a questionnaire system. Further, our emerging data indicate that Vocal are involving people from a wider range of ages and with a greater diversity of ethnic backgrounds in health research, as compared to available national data. Specifically, Vocal involves more people of Asian, African and Caribbean heritage, and includes a wider range of ages in its PPIE activities. More women than men are involved in Vocal's work. CONCLUSION: Our 'learn by doing' approach to assessing who does and doesn't take part in Vocal's PPIE activities has informed our practice and continues influence our strategic priorities for PPIE. Our system and learning reported here may be applicable and transferable to other similar settings in which PPIE is carried out. We attribute the greater diversity of our public contributors to our strategic priority and activities to promote more inclusive research since 2018.

Patient and public involvement and engagement (PPIE) can improve the relevance, quality, ethics and impact of research thus contributing to high quality research. Currently in the UK, people who get involved in research tend to be aged 61 years or above, White and female. Calls for greater diversity and inclusion in PPIE have become more urgent especially since the COVID-19 pandemic, so that research can better address health inequalities and be relevant for all sectors of society. Yet, there are currently no routine systems or requirements to collect or analyse the demographics of people who get involved in health research in the UK. Vocal is a non-profit organisation which supports PPIE in health research across the region of Greater Manchester in England. Since 2018, one of Vocal's strategic priorities has been to promote inclusive research by diversifying those who are engaged and involved in research, through the development of more inclusive ways of working together, including methods to understand who is (and isn't) currently involved in Vocal's PPIE activities. We find that it's feasible to capture and analyse demographic data related to PPIE. Further, our emerging data indicate that we are involving people from a wider range of ages and with a greater diversity of ethnic backgrounds in PPIE for health research, as compared to available national data. However, similarly to national trends, more women than men are involved in PPIE work.

Adapting Patient and Public Involvement processes in response to the Covid-19 pandemic.

BACKGROUND: The COVID-19 pandemic brought rapid and major changes to research, and those wishing to carry out Patient and Public Involvement (PPI) activities faced challenges, such as restrictions on movement and contact, illness, bereavement and risks to potential participants. Some researchers moved PPI to online settings during this time but remote consultations raise, as well as address, a number of challenges. It is important to learn from PPI undertaken in this period as face-to-face consultation may no longer be the dominant method for PPI. METHODS: UK stay-at-home measures announced in March 2020 necessitated immediate revisions to the intended face-to-face methods of PPI consultation for the ESORT Study, which evaluated emergency surgery for patients with common acute conditions. PPI plans and methods were modified to all components being online. We describe and reflect on: initial plans and adaptation; recruitment; training and preparation; implementation, contextualisation and interpretation. Through first-hand accounts we show how the PPI processes were developed, experienced and viewed by different partners in the process. DISCUSSION AND CONCLUSIONS: While concerns have been expressed about the possible limiting effects of forgoing face-to-face contact with PPI partners, we found important benefits from the altered dynamic of the online PPI environment. There were increased opportunities for participation which might encourage the involvement of a broader demographic, and unexpected benefits in that the online platform seemed to have a 'democratising' effect on the meetings, to the benefit of the PPI processes and outcomes. Other studies may however find that their particular research context raises particular challenges for the use of online methods, especially in relation to representation and inclusion, as new barriers to participation may be raised. It is important that methodological challenges are addressed, and researchers provide detailed examples of novel methods for discussion and empirical study. PATIENT AND PUBLIC CONTRIBUTION: We report a process which involved people with lived experience of emergency conditions and members of the public. A patient member was involved in the design and implementation, and two patients with lived experience contributed to the manuscript.

Codeveloping and Evaluating a Campaign to Reduce Dementia Misconceptions on Twitter: Machine Learning Study.

Background: Dementia misconceptions on Twitter can have detrimental or harmful effects. Machine learning (ML) models codeveloped with carers provide a method to identify these and help in evaluating awareness campaigns. Objective: This study aimed to develop an ML model to distinguish between misconceptions and neutral tweets and to develop, deploy, and evaluate an awareness campaign to tackle dementia misconceptions. Methods: Taking 1414 tweets rated by carers from our previous work, we built 4 ML models. Using a 5-fold cross-validation, we evaluated them and performed a further blind validation with carers for the best 2 ML models; from this blind validation, we selected the best model overall. We codeveloped an awareness campaign and collected pre-post campaign tweets (N=4880), classifying them with our model as misconceptions or not. We analyzed dementia tweets from the United Kingdom across the campaign period (N=7124) to investigate how current events influenced misconception prevalence during this time. Results: A random forest model best identified misconceptions with an accuracy of 82% from blind validation and found that 37% of the UK tweets (N=7124) about dementia across the campaign period were misconceptions. From this, we could track how the prevalence of misconceptions changed in response to top news stories in the United Kingdom. Misconceptions significantly rose around political topics and were highest (22/28, 79% of the dementia tweets) when there was controversy over the UK government allowing to continue hunting during the COVID-19 pandemic. After our campaign, there was no significant change in the prevalence of misconceptions. Conclusions: Through codevelopment with carers, we developed an accurate ML model to predict misconceptions in dementia tweets. Our awareness campaign was ineffective, but similar campaigns could be enhanced through ML to respond to current events that affect misconceptions in real time.

The benefits of continuing patient and public involvement as part of a randomised controlled trial during the Covid-19 global pandemic

Patient and public involvement (PPI) in clinical research strengthens the quality and relevance of research, and has been crucial to ensure that researchers continue to investigate relevant and important topics during the global Covid-19 pandemic. The MICE (Mental Health Intervention for Children with Epilepsy) randomised controlled trial relies upon PPI to steer the direction and delivery of the trial, and the PPI Research Advisory Group (RAG) adapted to remote online meetings during the pandemic. This article first describes how the PPI RAG supported the research trial during the course of the pandemic, particularly with key trial stages of recruitment, retention and follow-up. It considers how the PPI tasks were adapted to ensure that they remained meaningful throughout this period, particularly for children and young people. Second, the article explores the acceptability of PPI in research using teleconferencing methods, via a co-produced survey of the PPI group members. Survey results indicated that, while participants valued face-to-face meetings, having remote PPI meetings was preferable to having nothing. There was some suggestion that teleconferencing platforms make it challenging for reserved members of the group, and for children, to contribute. Our findings emphasise the importance of continuing PPI even when circumstances are sub-optimal. We hope that our findings will contribute to the wider conversation about what makes PPI effective, particularly in a digital world. [ FROM AUTHOR] Copyright of Research for All is the property of UCL Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Using telepresence robots as a tool to engage patient and family partners in dementia research during COVID-19 pandemic: a qualitative participatory study.

BACKGROUND: Long-term care (LTC) settings have been disproportionately affected by the COVID-19 pandemic; it is important to address unmet needs and explore practical strategies for supporting LTC residents and staff. The involvement of patient partners and family community members in research planning, implementation and evaluation is the basis of Patient and Public Involvement approach and has been challenging during the COVID-19 pandemic, as visitation restrictions have created barriers to conducting research in healthcare settings. Innovative methods and tools are needed for conducting participatory research. This study investigated the use of telepresence as innovative tools for participatory research based on three projects conducted with patient and family partners during the COVID-19 pandemic. METHODS: The data source includes (a) team reflective discussions, (b) weekly meeting notes, (c) field notes, and (d) interviews with ten researchers. We applied purposive sampling to select ten researchers who used a telepresence robot to conduct research in British Columbia, Canada. Semi-structured one-to-one interviews were conducted via Zoom virtual meetings. Patient and family partners contributed to team analysis to identify themes. RESULTS: Analysis of the data produced five themes: (1) Research Enabler, (2) User-Friendly Technology, (3) Increased Engagement, (4) Lack of Infrastructure and Resources, and (5) Training and Technical Obstacles. Based on the results, we propose "ROBOT"-an acronym for five actionable recommendations to support the use of telepresence robots for research. The ROBOT recommendations represent: Realign to adapt, Organize with champions, Blend strategies, Offer timely technical assistance, and Tailor training to individual needs. CONCLUSIONS: This study offers practical insights into the use of telepresence robots as a safe and innovative tool for conducting remote research with people with dementia, even in times of restricted access, as with COVID-19. Future research should apply more creativity and flexibility in adopting technology to expand possibilities for involving people with dementia in research.

It is important to address unmet needs and explore practical strategies for supporting long-term care (LTC) residents and staff who have been disproportionately affected by the COVID-19 pandemic. Involving patient partners and family community members in research planning, implementation, and evaluation is crucial for understanding the challenges faced by LTC residents. However, the restrictions on visitation and staff shortages during the pandemic have made this difficult. This study investigated the use of telepresence robots as innovative tools for participatory research. We interviewed ten researchers who used telepresence robots to conduct remote research in British Columbia, Canada. Semi-structured one-to-one interviews were conducted via Zoom meetings and analyzed to find common themes. Based on the analysis of the interviews and our reflection, five themes were found: (1) Research Enabler, (2) User-Friendly Technology, (3) Increased Engagement, (4) Lack of Infrastructure and Resources, and (5) Training and Technical Obstacles. Based on these findings, we propose "ROBOT"­an acronym for actionable recommendations to support the use of telepresence robots for research. These recommendations include: Realign to adapt, Organize with champions, Blend strategies, Offer timely technical assistance, and Tailor training to individual needs. This study provides insights into the use of telepresence robots as safe and innovative tools for conducting research with patient and family partners remotely, even in times of restricted access, such as during the COVID-19 pandemic.

It's time to 'Build Back Fairer': what can we do to reduce health inequalities in cardiology?

Disparities in cardiovascular morbidity and mortality are among the leading health and social care concerns in the UK. The disruption of the COVID-19 pandemic to health services has further placed cardiovascular care and the respective patient communities at the sharp end, not least in exacerbating existing health inequalities across service interfaces and patients' health outcomes. While the pandemic engenders unprecedented constraints within established cardiology services, it conduces to a unique opportunity to embrace novel transformative approaches within the way we deliver patient care in maintaining best practices during and beyond the crisis. As the first step in navigating toward the 'new norm', a clear recognition of the challenges inherent in cardiovascular health inequalities is critical, primarily in preventing the widening of extant inequalities as cardiology workforces continue to build back fairer. We may consider the challenges through the lens of health services' diverse facets, including the aspects of universality, interconnectivity, adaptability, sustainability, and preventability. This article explores the pertinent challenges and provides a focused narration concerning potential measures to foster equitable and resilient cardiology services that are patient centred in the post-pandemic landscape.

The perception of risk in contracting and spreading COVID-19 amongst individuals, households and vulnerable groups in England: a longitudinal qualitative study.

BACKGROUND: Social distancing restrictions to manage the COVID-19 pandemic were put in place from March 2020 in the United Kingdom (UK), with those classed as "highly clinically vulnerable" advised to shield entirely and remain at home. However, personal risk perception has been shown to comprise of various elements beyond those outlined in the national pandemic guidance. It is unclear whether those deemed COVID-19 vulnerable identified as high-risk to COVID-19 and thus complied with the relevant advice. The aim of this research is to explore the perception of risk in catching and spreading COVID-19, amongst individuals from individual households, and vulnerable groups in a region of the UK. METHODS: Two individual, semi-structured interviews were conducted, four-weeks apart, with adults living in households in the Liverpool City Region. At the follow-up interview, participants were given the option of using photo-elicitation to guide the discussion. Reflexive thematic analysis was employed to conceptualise themes. The qualitative analysis was underpinned with symbolic interactionism. RESULTS: Twenty-seven participants (13:14 males:females, and 20 with a vulnerable risk factor to COVID-19) completed a baseline interview, and 15 of these completed a follow-up interview four-weeks later. Following thematic analysis, two overarching themes were conceptualised, with subthemes discussed: theme 1) Confusion and trust in the risk prevention guidance; and theme 2) Navigating risk: compliance and non-compliance with public health guidance. CONCLUSION: Participants developed their own understanding of COVID-19 risk perception through personal experience and comparison with others around them, irrespective of vulnerability status. COVID-19 guidance was not complied with as intended by the government, and at times even rejected due to lack of trust. The format in which future pandemic guidance is conveyed must be carefully considered, and take into account individuals' experiences that may lead to non-compliance. The findings from our study can inform future public health policy and interventions for COVID-19 and future pandemics.

COVID-19 Public Health Measures and Patient and Public Involvement in Health and Social Care Research: An Umbrella Review.

An umbrella review of previously published systematic reviews was conducted to determine the nature and extent of the patient and public involvement (PPI) in COVID-19 health and social care research and identify how PPI has been used to develop public health measures (PHM). In recent years, there has been a growing emphasis on PPI in research as it offers alternative perspectives and insight into the needs of healthcare users to improve the quality and relevance of research. In January 2022, nine databases were searched from 2020-2022, and records were filtered to identify peer-reviewed articles published in English. From a total of 1437 unique records, 54 full-text articles were initially evaluated, and six articles met the inclusion criteria. The included studies suggest that PHM should be attuned to communities within a sociocultural context. Based on the evidence included, it is evident that PPI in COVID-19-related research is varied. The existing evidence includes written feedback, conversations with stakeholders, and working groups/task forces. An inconsistent evidence base exists in the application and use of PPI in PHM. Successful mitigation efforts must be community specific while making PPI an integral component of shared decision-making.

Co-production of a feasibility trial of pacing interventions for Long COVID.

BACKGROUND: The high incidence of COVID-19 globally has led to a large prevalence of Long COVID but there is a lack of evidence-based treatments. There is a need to evaluate existing treatments for symptoms associated with Long COVID. However, there is first a need to evaluate the feasibility of undertaking randomised controlled trials of interventions for the condition. We aimed to co-produce a feasibility study of non-pharmacological interventions to support people with Long COVID. METHODS: A consensus workshop on research prioritisation was conducted with patients and other stakeholders. This was followed by the co-production of the feasibility trial with a group of patient partners, which included the design of the study, the selection of interventions, and the production of dissemination strategies. RESULTS: The consensus workshop was attended by 23 stakeholders, including six patients. The consensus from the workshop was to develop a clinical trial platform that focused on testing different pacing interventions and resources. For the co-production of the feasibility trial, patient partners selected three pacing resources to evaluate (video, mobile application, and book) and co-designed feasibility study processes, study materials and undertook usability testing of the digital trial platform. CONCLUSION: In conclusion, this paper reports the principles and process used to co-produce a feasibility study of pacing interventions for Long COVID. Co-production was effective and influenced important aspects of the study.

The World Health Organisation defines Long COVID as a condition which impacts people 3 months after they first had COVID-19. Some of the symptoms that characterise Long COVID symptoms include fatigue, breathlessness and brain fog. These symptoms have a major impact on people's health and quality of life. Today, over 2 million people in the United Kingdom suffer from Long COVID and there is a lack of drugs and non-drugs treatment. However, some non-drugs treatments which aim to manage fatigue in other conditions, such as pacing, could be used with people with Long COVID. In this paper, we report how we co-produced a study which tested whether or not it is feasible for people who have Long COVID to use a pacing resource and report their symptoms using an electronic platform. After a meeting to review existing non-drugs treatments, the research team and a group of patient partners agreed on co-developing a clinical trial platform to test different pacing resources. The research team then met with the patient partners twice a week to co-design the study during which people with Long COVID will use the pacing resources and report their symptoms. They also co-designed the study documents and how to report its results. Co-producing a study with patient partners was effective and influenced important aspects of the study.

DecodeME: community recruitment for a large genetics study of myalgic encephalomyelitis / chronic fatigue syndrome.

BACKGROUND: Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) is a common, long-term condition characterised by post-exertional malaise, often with fatigue that is not significantly relieved by rest. ME/CFS has no confirmed diagnostic test or effective treatment and we lack knowledge of its causes. Identification of genes and cellular processes whose disruption adds to ME/CFS risk is a necessary first step towards development of effective therapy. METHODS: Here we describe DecodeME, an ongoing study co-produced by people with lived experience of ME/CFS and scientists. Together we designed the study and obtained funding and are now recruiting up to 25,000 people in the UK with a clinical diagnosis of ME/CFS. Those eligible for the study are at least 16 years old, pass international study criteria, and lack any alternative diagnoses that can result in chronic fatigue. These will include 5,000 people whose ME/CFS diagnosis was a consequence of SARS-CoV-2 infection. Questionnaires are completed online or on paper. Participants' saliva DNA samples are acquired by post, which improves participation by more severely-affected individuals. Digital marketing and social media approaches resulted in 29,000 people with ME/CFS in the UK pre-registering their interest in participating. We will perform a genome-wide association study, comparing participants' genotypes with those from UK Biobank as controls. This should generate hypotheses regarding the genes, mechanisms and cell types contributing to ME/CFS disease aetiology. DISCUSSION: The DecodeME study has been reviewed and given a favourable opinion by the North West - Liverpool Central Research Ethics Committee (21/NW/0169). Relevant documents will be available online ( www.decodeme.org.uk ). Genetic data will be disseminated as associated variants and genomic intervals, and as summary statistics. Results will be reported on the DecodeME website and via open access publications.

A framework for implementing Patient and Public Involvement in mental health research: The PATHWAY research programme benchmarked against NIHR standards.

BACKGROUND: Patient and Public Involvement (PPI) in research has become a key component recommended by research commissioners, grant award bodies and specified in government policies. Despite the increased call for PPI, few studies have demonstrated how to implement PPI within large-scale research studies. OBJECTIVE: The aim of the current study was to provide a case example of the implementation of a patient advisory group in a large-scale mental health research programme (PATHWAY) and to benchmark this against UK standards. METHOD: A PPI group was incorporated throughout the PATHWAY research programme, from grant development to dissemination. The group attended regular meetings and supported participant recruitment, evaluated patient-facing documents, supported the piloting of the research intervention and co-developed the dissemination and impact strategy. The implementation of PPI throughout the project was benchmarked against the UK standards for PPI. RESULTS: The inclusion of PPI in the PATHWAY project provided tangible changes to the research project (i.e., improving study documents, co-developing dissemination materials) but also proved to be a beneficial experience to PPI members through the development of new skills and the opportunity to provide a patient voice in research. We show how PPI was involved across seven study phases and provide examples of implementation of the six UK standards. The study did not include PPI in data analysis but met all the UK standards for PPI. Challenges regarding practical components (i.e., meeting frequency, language use), increasing diversity and PPI members' knowledge of research were highlighted as areas for further improvement. CONCLUSIONS: We provide a case example of how PPI can be implemented throughout a research lifecycle and we note the barriers faced and make suggestions for PPI in future implementation and research. PATIENT AND PUBLIC CONTRIBUTION: PPI members were involved throughout the lifecycle of the research programme. The PPI lead was a co-author on the manuscript and contributed to report writing.

Then there were seven: a commentary on creating a public involvement strategy group for a policy research unit in behavioural science.

The National Institute for Health and Care Research (NIHR) Policy Research Unit in Behavioural Science (PRU-BS) was funded to inform government on the application of behavioural science in health and social care policy. What makes this unit different to other topic specific ones, was the wide range of its brief. Because of this, the PPI group would need to include a wide range of experience and expertise and be prepared to learn. We were a different type of public group for a different type of task. This paper deals with how we approached this. In this paper we outline how the PPI plan in the funding proposal for the PRU-BS was adapted to real world challenges. We describe the stages in the formation of the PPI Strategy Group and how a virtual platform was created to ensure good communication. We discuss our pragmatic approach of developing Terms of Reference and a PPI strategy document. Given the restrictions imposed by the Covid-19 pandemic we explain how we tackled PPI SG member induction sessions, meetings and training sessions. To illustrate how the group operates we provide an example of our involvement in a PRU-BS project. Central to our paper is the lessons we learned. We hope the challenges we met in forming the unique PPI SG, how these were overcome, and our recommendations will help others faced with a similar task.

The Policy Research Unit in Behavioural Science (PRU-BS) was formed in early 2019, funded by the National Institute for Health and Care Research (NIHR). The aim of the unit is to advise the government on the use of behavioural science (the study of human behaviour) to inform health and social care policy. From the outset the aim was to embed PPI in all aspects of the unit's work from the governance and direction of the unit to the individual research projects it conducts. As behavioural science cuts across all aspects of health, recruiting members of the public to work within the PRU-BS required careful thought. In this paper we describe the processes of recruiting to our PPI Strategy Group, the induction and training, and the ways in which we worked to develop the group and become embedded within the unit. Lastly, we present several recommendations based on our experiences of forming the PPI Strategy Group. Although this is aimed primarily at those contemplating setting up a group whose remit extends beyond a single research project, we hope this will be a useful resource for the public, researchers and others working in PPI.

Trauma-informed patient and public-engaged research: Development and evaluation of an online training programme.

INTRODUCTION: As patients, members of the public, and professional stakeholders engage in co-producing health-related research, an important issue to consider is trauma. Trauma is very common and associated with a wide range of physical and behavioural health conditions. Thus, it may benefit research partnerships to consider its impact on their stakeholders as well as its relevance to the health condition under study. The aims of this article are to describe the development and evaluation of a training programme that applied principles of trauma-informed care (TIC) to patient- and public-engaged research. METHODS: A research partnership focused on addressing trauma in primary care patients ('myPATH') explicitly incorporated TIC into its formation, governance document and collaborative processes, and developed and evaluated a free 3-credit continuing education online training. The training was presented by 11 partners (5 professionals, 6 patients) and included academic content and lived experiences. RESULTS: Training participants (N = 46) positively rated achievement of learning objectives and speakers' performance (ranging from 4.39 to 4.74 on a 5-point scale). The most salient themes from open-ended comments were that training was informative (n = 12) and that lived experiences shared by patient partners were impactful (n = 10). Suggestions were primarily technical or logistical. CONCLUSION: This preliminary evaluation indicates that it is possible to incorporate TIC principles into a research partnership's collaborative processes and training about these topics is well-received. Learning about trauma and TIC may benefit research partnerships that involve patients and public stakeholders studying a wide range of health conditions, potentially improving how stakeholders engage in co-producing research as well as producing research that addresses how trauma relates to their health condition under study. PATIENT OR PUBLIC CONTRIBUTION: The myPATH Partnership includes 22 individuals with professional and lived experiences related to trauma (https://www.usf.edu/cbcs/mhlp/centers/mypath/); nine partners were engaged due to personal experiences with trauma; other partners are community-based providers and researchers. All partners contributed ideas that led to trauma-informed research strategies and training. Eleven partners (5 professionals, 6 patients) presented the training, and 12 partners (8 professionals, 4 patients) contributed to this article and chose to be named as authors.

Voices of women in homelessness during the outbreak of the COVID-19 pandemic: a co-created qualitative study.

BACKGROUND: Women in homelessness face extreme health- and social inequities. It could be postulated that during societal crises, they become even more vulnerable. Thus, the aim was to explore experiences related to the COVID-19 pandemic among women in homelessness. METHODS: Ten interviews were conducted with women in homelessness, in Stockholm, Sweden, using researcher-driven photo elicitation. The data analysis was guided by the DEPICT model for collaborative data analysis and a qualitative content analysis was performed. A collaborative reference group of women with lived experience of homelessness contributed to the research process through designing the data collection, performing the data analysis, and providing feedback during report writing. RESULTS: For women in homelessness, the COVID-19 pandemic was adding insult to injury, as it significantly affected everyday life and permeated most aspects of existence, leading to diminished interactions with others and reduced societal support. Thus, in an already dire situation, the virus amplified health- and social issues to another level. The women strived to find their balance on the shifting sands of guidelines and restrictions due to the pandemic. Adhering to the new social distancing rules and guidelines in line with the rest of society, was simply impossible when experiencing homelessness. However, for some women the pandemic was nothing but a storm in a teacup. The harsh reality continued irrespectively, living one day at a time and prioritizing provision for basic human needs. CONCLUSIONS: The COVID-19 pandemic and homelessness can be viewed as two intersecting crises. However, the women's aggregated experiences were greater than the sum of experiencing homelessness and meeting the threat of the virus. Gender, exposure to violence, poverty, social isolation, and substance use were additional factors that further marginalized the women during the pandemic. To rebuild a better and more sustainable post-pandemic future for all, global commitment to ending homelessness is crucial. In addition, addressing social determinants of health must be the number one health intervention.

Impact Of The COVID-19 Pandemic In The Brazilian National Committee for Health Technology Incorporation (Conitec) Recommendation Process

IntroductionHealth Technology Assessment (HTA) Process assists decision-making in health policies. The COVID-19 pandemic caused a high demand on protocol or guideline updates and incorporation of new drugs or therapies, overwhelming local agencies. A recent study reported that major HTA bodies in England, Scotland, Germany, and Canada reduced their number of drug recommendations in 2020, due to reprioritization of resources and COVID-related challenges. The present study aimed to evaluate the impact of the COVID-19 pandemic at the Brazilian National Committee for Health Technology Incorporation (Conitec) recommendation process.MethodsThis descriptive study evaluated all official recommendation reports available on the Government website in 2020 and 2021, extracting the data of disease category, technology type, the aim of the report, Public Involvement, and final result for the recommendation. The results were presented in tabular and graphical form using the machine learning, through the software R studio and excel.ResultsA total of 168 documents were evaluated, including guidelines and recommendation reports, with no reduction in the number of evaluations considering 2019. In 2020, there was a more significant evaluation of guidelines, and in 2021, a report on the non-incorporation of technologies. There were four specific documents about COVID 19, including vaccines and hospital care guidelines. The most incorporated and non-incorporated technologies were medication, targeting rare and highly prevalent diseases in balance. The Brazilian government was the main proposer. These results are part of the study "A Survey about the core methods of the recommendation reports for Brazilian Ministry of Health carried out by Brazilian Health Technology Assessment Centers”, which will characterize and analyze the core methods of the recommendation reports conducted by the Brazilian HTA Centers.ConclusionsThe pandemic had a low impact on demands in the routine of the Conitec. Establish indicators and technological norms applicable to health services, contribute to the identification of possible new practices, methods or criteria.