Patient And Public Involvement Group Research Articles

Rationale and design of the Self-TI Study protocol: a cross-sectional human papillomavirus self-testing pilot study among transgender adults in England

IntroductionPersistent infection with high-risk human papillomavirus (HPV) is the causal agent of several cancers including cervical, anal and oropharyngeal cancer. Transgender men and transmasculine non-binary (TMNB) people with a cervix...

Contextualising and challenging under-representation in research in light of Cultural Trauma: a qualitative focus group and interview study

BackgroundAlthough underserved populations— including those from ethnic minority communities and those living in poverty—have worse health and poorer healthcare experiences, most primary care research does not fairly reflect these groups. Patient and public involvement (PPI) is usually embedded within research studies in the United Kingdom (UK), but often fails to represent underserved populations. This study worked with patient and public contributors and local community leaders, situated in a socio-economically deprived and ethnically diverse urban area, to explore under-representation in primary healthcare research.MethodsWe undertook a focus group with a purposive sample of 6 members of a Patient and Public Involvement Group (PPIG), and interviews with 4 community leaders (representing Black, South Asian, Roma and socio-economically deprived communities). An iterative analysis process based on template analysis was used. Focus group 1 was rapidly analysed, and a template created. Findings were presented in focus group 2, and the template further developed. The Cultural Trauma concept was than applied to the template to give a wider theoretical lens. In-depth analysis of focus groups and interviews was then performed based on the template.ResultsWider societal and historical influences have degraded trust in academic and healthcare institutions within underserved populations. Along with more practical considerations, trust underpins personal motivations to engage with research. Researchers need to invest time and resources in prolonged, mutually beneficial engagement with communities of importance to their research, including sharing power and influence over research priorities. Researcher reflexivity regarding differential power and cultural competencies are crucial. Utilising participatory methodologies including co-production demonstrates a commitment to inclusive study design.ConclusionsRe-framing evidence-based medicine to be more useful and relevant to underserved populations with the highest burden of ill health is urgently needed. Lack of representation in primary healthcare research reflects wider societal inequalities, to which Cultural Trauma provides a useful lens. However, there are actions that researchers can take to widen representation. This will ultimately help achieve the goal of increased health equity by enhancing scientific rigour and research generalizability.

Patient and public involvement in liver disease management and research: insights into the development of a patient group

Background: Patient and public involvement (PPI) is increasingly recognised as crucial for enhancing healthcare and research relevance. This case study aimed to describe the development of a PPI group within the context of liver disease management and research, highlighting opportunities and challenges encountered. Methods: Patients with liver disease were recruited from a gastroenterology department through an online survey. An initial group discussion meeting was held using a nominal group technique, focusing on establishing the group's purpose, identifying areas of interest for involvement and determining practical organisational aspects. Ongoing collaboration occurred through regular meetings and communication. Results: A total of 18 patients actively participated in the group. Their motivations included utilising lived experiences to support others, gain knowledge about liver disease and raise public awareness. The group contributed to developing patient information, nurse-led consultations and a patient application. Additionally, they identified a need for research on improving healthcare system pathways for liver disease patients. Conclusions: This case study demonstrates a sustainable model for PPI in liver disease. Opportunities included empowering patients as consultants, collaborators and potential patient-led researchers. Challenges included addressing diversity within the group and ensuring adequate resources for PPI activities. This study provides valuable insights for healthcare professionals and researchers seeking to implement PPI in their own settings.

What works for whom, how and why in mental health education for undergraduate health profession students? A realist synthesis protocol

IntroductionIt has been shown that mental health education can support positive attitudes of health profession students towards people with mental health challenges, which supports them to provide optimal healthcare to...

Advance Care Planning Website for People With Dementia and Their Family Caregivers: Protocol for a Development and Usability Study.

Web-based tools for people with dementia and their family caregivers have considerably increased over the years and offer promising solutions to several unmet needs such as supporting self-care in daily life, facilitating treatment delivery, or ensuring their ability to communicate. The use of web-based tools in the field of advance care planning (ACP) for people with dementia and their family caregivers has yet to be explored and requires careful consideration, given the sensitive topic and the specific needs of people with dementia and their families. This paper reports the protocol for a study aiming to develop and simultaneously test the usability of an ACP website designed for, and with, people with dementia and their families. The development of the website is based on a process map for the development of web-based decision support interventions and on the Medical Research Council framework for complex intervention development and evaluation. Additionally, we apply a user-centered approach in combination with patient and public involvement (PPI) throughout the development process. We describe our iterative development approach to the website. Participants and a PPI group give feedback on 4 prototypes of the ACP website. For each iteration, we aim to include 12 participants (3 people with dementia, 3 family caregivers, and 3 dyads) in usability testing. In the first 3 iterations, usability testing includes (1) a think-aloud exercise, (2) researcher observations, and (3) the System Usability Scale questionnaire. The last iteration of usability testing is composed of a semistructured interview assessing the layout, content, face validity, and readability of the website. Qualitative data from the think-aloud exercises and interviews are analyzed using thematic analysis. Mean scores are calculated for the System Usability Scale questionnaire. This study received approval from the Ethical Review Board of Brussels University Hospital of the Vrije Universiteit Brussel. Recruitment began in October 2021. The target date for paper submission of the results of the development and usability testing will be in 2023. The methods in this protocol describe a feasible and inclusive approach to the development of an ACP website together with people with dementia, their family caregivers, and other stakeholders. We provide a clear overview of how to combine PPI input and user-centered development methods, leading to a transparent and reliable development process. This protocol might stimulate the active participation of people with dementia, their caregivers, and regional stakeholders in future studies on web-based technologies. The results of this study will be used to refine the design and create a relevant and user-friendly ACP website that is ready to be tested in a larger evaluation study. DERR1-10.2196/46935.

The patient voice: More than a tick box exercise?

Patient and public involvement (PPI) in healthcare professional education is important, yet publications often provide insufficient detail about the types of involvement patients undertake and the level of autonomy that they have. This study details the factors that promote or hinder PPI within a university healthcare professional education setting and the types of activities members conducted. PPI activities were described and mapped against a framework for PPI in healthcare professional education. Semi-structured interviews with PPI group members explored the motivators, enablers and barriers that influence involvement. The framework highlighted that the PPI group were involved in a range of activities, yet they received limited training for their role and were infrequently involved in planning the activities. When interviewed, PPI members did not consider that these factors were the important promoters or barriers to involvement, instead emphasising five themes: (1) their individual characteristics, (2) factors relating to the university organisation, (3) relationships between themselves, faculty and students, (4) time in their role and (5) evidence of their impact. Supporting PPI members whilst working, rather than provision of formal training was considered most empowering for group members. This was mediated through having enough time in their role to develop supportive relationships with faculty, which in turn promoted self-confidence and increased autonomy. This should be considered when making PPI appointments. Small changes in processes during education planning can make it easier for PPI members to bring their own agenda forward and promote equity during education decision making.

What are the information needs of people with dementia and their family caregivers when they are admitted to a mental health ward and do current ward patient information leaflets meet their needs?

An admission to a mental health ward is an uncertain and unexpected part of a person's journey with dementia and consequently, families require information about what to expect and how to prepare. This study aimed to establish the information needs of people with dementia and their families at the point of admission to a mental health ward and to collate existing ward information leaflets to explore if they meet these information needs. This research was conducted in two parts: (1) a qualitative study using focus groups, one with people with dementia and family carers with lived experience of such an admission (n = 6), and another with Admiral Nurses (n = 6) to explore information needs at the point of admission. (2) Each National Health Service(NHS) mental health trust (n = 67) was asked to provide a copy of their ward information shared at admission. A total of 30 leaflets were received from 15 NHS trusts; after removing duplicates, 22 were included. A content analysis was conducted to evaluate to what extent leaflets met the information needs identified by focus groups. Two main categories 'honest, accurate and up-to-date information' and 'who is the information for' and four subcategories were derived from focus group data. Participants felt that people with dementia and their families were likely to have different information needs. Material for people with dementia needed to be in an accessible format. Information should cover the aim of the admission, a timeline of what to expect and details about how families will be involved in care. Practical information about what to pack and ward facilities was valued. Participants spoke about the need to consider the tone of the information, given that people are likely to be distressed. The information leaflets reviewed did not meet the information needs identified by focus group participants. People with dementia and family carers have different information needs at the point of admission to a mental health ward. Information provided to people with dementia needs to be in an accessible format with content relevant to these needs. Wards should aim to co-create information to ensure that they meet people's information needs. This research was supported by a patient and public involvement (PPI) group of people with dementia and carers who have experience in mental health wards. The idea for the study came from the group and was motivated by their experiences. The PPI group helped with the design of the study and took part in the focus groups. The information generated has been written up in this paper, and the knowledge generated has also been used to co-create a guide for wards on writing their information leaflets and to support the co-creation of a public information leaflet by Dementia UK about mental health admissions for people with dementia.

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

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. 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. 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 interventionand co-developed the dissemination and impact strategy. The implementation of PPI throughout the project was benchmarked against the UK standards for PPI. 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 diversityand PPI members' knowledge of research were highlighted as areas for further improvement. 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. 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.

Hereditary renal cancer patient and public involvement group: A collaborative, consensus decision process to develop a communication tool for patient use.

Patient and public involvement (PPI) must be more frequently embedded within clinical research to ensure translational outcomes are patient-led and meet patient needs. Active partnerships with patients and public groups are an important opportunity to hear patient voices, understand patient needs, and inform future research avenues. A hereditary renal cancer (HRC) PPI group was developed with the efforts of patient participants (n = 9), pooled from recruits within the early detection for HRC pilot study, working in collaboration with researchers and healthcare professionals (n = 8). Patient participants had HRC conditions including Von Hippel-Lindau (n = 3) and Hereditary Leiomyomatosis and Renal Cell Carcinoma (n = 5), and public participants included two patient Trustees (n = 2) from VHL UK & Ireland Charity. Discussions among the enthusiastic participants guided the development of a novel patient information sheet for HRC patients. This communication tool was designed to aid patients when informing family members about their diagnoses and the wider implications for relatives, a gap identified by participants within group discussions. While this partnership was tailored for a specific HRC patient and public group, the process implemented can be employed for other hereditary cancer groups and could be transferable within other healthcare settings.

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.

Influences on indoor environmental trigger remediation uptake for children and young people with asthma: A scoping review.

Children and young people (CYP) with asthma can benefit from reduced exposure to indoor environmental allergens and triggers but may not consistently have avoidance strategies implemented. To inform future interventions to increase trigger and allergen avoidance and enhance asthma control, a greater understanding of the influences on avoidance behaviours is necessary. A systematic scoping review was selected to summarize evidence on what influences family uptake of indoor environmental asthma trigger avoidance strategies for CYP with asthma and identify research gaps. Primary studies of any design, including CYP (≤18 years) with asthma, and/or parent-carers, available in English and conducted since 1993, were eligible. Searches included nine databases, hand-searching reference lists and citation searching. Thirty-three articles were included and are summarized narratively due to heterogeneity. Influences appear complex and multifactorial and include barriers to strategy uptake, health beliefs and personal motivation. Research specifically related to family understanding of allergic sensitisation status and exposure risks, and how these may inform avoidance implementation is required. Patient and public involvement (PPI) was not reported in included articles, although two studies used participatory methods. There is limited research on family asthma trigger management, particularly what influences current management behaviours. Variation in families' ability to identify important triggers, understand exposure riskand consistently reduce exposures warrants further exploratory research to explain how families reach avoidance decisions, and what future interventions should aim to address. Further PPI-informedresearch to address such gaps, could enable theory-based, person-centred interventions to improve the uptake of asthma trigger remediation. An asthma-specific PPI group contributed to the decision-making for the funding for the wider project this review sits within. The findings of this scoping review have informed the subsequent phases of the project, and this was discussed with PPI groups (both adult and CYP groups) when proposing the next phases of the project.

P066 COVID Voices: co-produced research to explore the shielding experiences of people with inflammatory musculoskeletal disease

Abstract Background/Aims Up to one-third of people living with inflammatory arthritis or auto-immune disease may have been classified as ‘clinically extremely vulnerable’ (CEV) to COVID-19 and required to ‘shield’. Communication regarding shielding notification and details of how to shield were unclear, causing confusion and uncertainty. Most research into the impact of shielding on people living with musculoskeletal disease has involved either quantitative or survey-based data, with little patient involvement. This project aims to capture patient “stories” to understand and explore the experiences of people with inflammatory musculoskeletal conditions who shielded, using co-produced, qualitative methodology. Methods The Centre for Epidemiology Versus Arthritis (CfE) is committed to involving patients and the public, convening a COVID-19 Patient and Public Involvement (PPI) group early in the pandemic. Two PPI group members developed the research idea and collaborated with a clinical academic to co-produce a successful grant application to the Versus Arthritis “New opportunities” fund. The research aims to capture experiences and opinions on the processes for determining and communicating who is identified as CEV, and the impact of shielding upon individuals’ lives. We will develop recommendations to improve the process for subsequent pandemics. People who shielded due to inflammatory arthritis / auto-immune disease are invited to discuss their experiences of shielding in semi-structured interviews (n = 30) or focus groups (n = 12). Up to 50 participants may submit creative materials (artwork, poetry, photographs or written word), to include those unable, or unwilling, to speak about their experiences. A framework approach to thematic analysis of data generated from interviews and focus groups will be employed. Creative materials will be used to illustrate these themes. In addition to the core team, an experienced Patient Advisory Group will contribute to the analysis. Full ethical approval was awarded by the University of Manchester Research Ethics Committee. The ‘core team’ (two patient/public contributors and a clinical academic) are committed to ‘co-production’: working together in equal partnership, driven by values such as transparency, sharing power and inclusivity, which we anticipate will improve the relevance and quality of this work. Results Recruitment to interview and focus groups was exceeded within 10 days. Half the creative materials participants were recruited within a month, and recruitment remains open. The team have given invited talks at several national and regional events, discussing the research and methodological approach, demonstrating the significant interest generated by this work. Conclusion Although most funders now mandate some form of PPI in grant applications, research ideas conceived and genuinely co-produced by patient partners are rare. The CfE’s commitment to PPI enabled conversations and collaboration, which built on existing relationships, and led to successful grant funding. We look forward to further highlighting and sharing both the model of our collaboration, and the qualitative research findings. Disclosure J. Fox: None. L. Laidlaw: None. W.G. Dixon: Consultancies; WGD has received consultancy fees from Abbvie and Google, unrelated to this work. C. Sanders: None. C.A. Sharp: None.

Cancer treatment decisions for people living with dementia: Experiences of family carers, a qualitative interview study.

BackgroundAs the UK population ages, the prevalence of both dementia and cancer will increase. Family carers of people with dementia who are subsequently diagnosed with cancer are often involved in treatment decisions about cancer. These decisions are uniquely challenging.ObjectivesTo explore the experience of carers involved in cancer treatment decisions for people with dementia.DesignA cross‐sectional qualitative interview study with inductive thematic analysis.Setting and ParticipantsSixteen carers of people with dementia were identified via Primary Care Research Networks and the Join Dementia Research database.ResultsThree main themes were derived: ‘already at breaking point’, which describes the extreme strain that carers were already under when the cancer diagnosis was made; ‘maintaining the status quo’, which describes how despite the gravity of a cancer diagnosis, avoiding further dementia‐related deterioration was of prime importance; and ‘LPA’, which explores the benefits and frustrations of the use of lasting powers of attorney.DiscussionCurrent services are ill‐equipped to deal with people who have a combination of dementia and cancer. Proxy decisions about cancer care are made in the context of carer stress and exhaustion, which is exacerbated by shortcomings in service provision.ConclusionsAs the prevalence of comorbid cancer and dementia rises, there is an urgent need to improve services that support carers with proxy health care decision‐making.Patient or Public ContributionThe study design was codeveloped with a local dementia‐specific patient and public involvement (PPI) group. A project‐specific PPI group was formed with support from the Alzheimer's Society Research Partnership scheme to provide further bespoke input.

Patient and public involvement in research design and oversight.

In recent years, the value of patient and public involvement (PPI) in developing research has become apparent. Patients and service users have insights that are essential to successfully developing and completing research. PPI collaborations may improve the scope, quality, relevance and impact of research. Nevertheless, there are challenges for nurse researchers in ensuring effective PPI is embedded in research proposals and practice. To discuss the practical aspects of developing a PPI group, including one approach to convening a PPI group, and provide examples of where a PPI group has refined and improved the design of research. Directly inviting patients and members of the public to collaborate in the research resulted in successful working relationships and tangible improvements to a study's methodology. None of the patients approached had considered collaborating in research before and so would not have been reached by any other means. There are several approaches nurse researchers can take to convene a PPI group, including open forums and relevant charity groups. The authors' experience was broadly successful, although future research would involve collaboration with other teams to recruit more diverse groups. Nurse researchers are ideally placed to collaborate with patients and members of the public in designing and delivering research.

OP338 Involving Patients In Research: Early Consultation Of Women To Improve Study Design And Investigate Trial Acceptability

IntroductionGaining the perspective of patients is invaluable in the design, management and reporting of research. As part of the process of facilitating clinical research into the effectiveness of a digital colposcope in a cervical cancer pathway, patients were involved from the outset.MethodsUsing funding made available by a Public Involvement Fund, a patient consultation group was established. The group's initial discussions informed the design of a feasibility study and funding application, which was submitted to the UK National Institute of Health Research (NIHR). A Patient and Public Involvement (PPI) representative was recruited and along with the consultation group, contributed to the ethical approvals for the study. The Patient Information Sheet and Consent Form were reviewed by the patients, to ensure readability, understandability and accessibility. The patient questionnaires and interview topics that are part of the feasibility study were also developed in conjunction with the PPI group, to make sure that women's concerns are being addressed in the research design and protocols.ResultsThe PPI consultation group's contributions helped strengthen the funding application and funding for a feasibility study was granted as part of the NIHR's Research for Patient Benefit funding scheme. Part of the grant will be used for training and reimbursement for time spent for the PPI representative. Data collection for the study is due to commence in the summer of 2021. The PPI group will be consulted at the beginning and end of the data collection period and will contribute to the data analysis and dissemination of the research output, including a Plain English Summary.ConclusionsInvolving patients greatly amplified the quality of the funding and ethical applications and will continue to benefit the ongoing research. Resources were widely available within the researcher's University and also through UK-wide schemes. Such resources are crucial and should be encouraged as part of all clinical research.

Development of the Rheumatoid Arthritis Distress Scale (RADS): a new tool to identify disease-specific distress in patients with Rheumatoid Arthritis

BackgroundPatients with Rheumatoid Arthritis (RA) may experience psychological distress (depression, anxiety) in addition to their physical symptoms. People with RA may also experience disease-specific distress (DSD), related to the specific burden of living with their life-long condition. DSD is a patient reported outcome in several long-term conditions, including type 1 and 2 diabetes. The aims of this study were to determine whether DSD is experienced by people with RA, and if so, develop a Patient Reported Outcome Measure (PROM) to assess for DSD in people with RA.MethodsA five-phased qualitative study was conducted which consisted of a secondary data analysis of 61 interviews of people with rheumatological disease (Phase 1), validation of findings via a Patient and Public Involvement (PPI) group of people with RA (n = 4) (Phase 2), item generation for a PROM (Phase 3) and establishing face and content validity of the PROM via PPI group (n = 4) and individual cognitive interviews (n = 9) of people with RA respectively (Phase 4 and 5). The final PROM was presented at a Patient Education Evening for patients with long-term rheumatological conditions, including RA, and carers.ResultsFive themes of rheumatological disease distress emerged from Phase 1, which were validated in the Phase 2 PPI group. After Phases 3–5, the Rheumatoid Arthritis Distress Scale (RADS) was formed of 39 items and 3 supplementary questions. Overall participants reported the content of the RADS to be clear and relevant, and that DSD is a valid concept in RA, distinct from other entities like clinical depression or anxiety.ConclusionsDSD appears to be an important concept in RA. The 39-item RADS demonstrates acceptable face and content validity in this patient group. Further psychometric testing is needed. The RADS may be a useful tool for healthcare professionals to identify RA distress.

Bridging the Gap: Development of a Patient Public Involvement Group

Abstract Aims Every year, the Queen Elizabeth Hospital Birmingham (QEHB) neuro-oncology team review over 2000 individuals with brain tumour. Patient and public involvement (PPI) has been fragmented to date. Initially we invited two patient advocates and a core group of allied health professionals to meet virtually to discuss development of a local PPI group, its aims, specific goals, and timescales to maintain momentum. In March 2021 we launched “BERTI: Brain tumour Education and Research paTient and public Involvement group, West Midlands”. Our inaugural meeting will be virtual in April 2021 and will be followed by three meetings per year. Method We developed information leaflets to promote the BERTI initiative. A membership form has been developed to record baseline information (non-clinical) e.g. contact details, which tumour type the individual is interested in, which aspect of BERTI they are interested in (Education, Research or Clinical service development). Patient advocates have reviewed all patient and public facing forms. All forms have been checked by Information Governance at QEHB to ensure General Data Protection Regulation compliant. Contact details and non-clinical data will be stored in a password protected database on a NHS computer network. Information to ensure members can unsubscribe from this group is easy to find and will be done immediately. A BERTI email account has been set up with a core group of professionals having access who are all fully trained in data protection and have GDPR certification. We will produce an annual BERTI newsletter. Results BERTI is a group for people affected by brain tumours in any way. We include patients, friends and family, health professionals and researchers who are committed to improving the care of people with a brain tumour. It is run between the QEHB and University of Birmingham (UoB). BERTI provides a forum to meet other people affected by brain tumours and - Share experiences; - Understand the condition better; - Work with clinical staff and researchers to improve clinical care and facilitate research for people living with brain tumours. We will meet three times per year, virtually at the moment but face to face once Covid restrictions ease. We will have a formal talks explaining certain aspects of brain tumour or research initiatives. Throughout, there will be dedicated time set aside for group discussions to promote a genuine two-way dialogue between health-care/research professionals and individuals affected by brain tumour. Conclusion The PPI group will be allowed to evolve rather than start out too prescriptive. It will capitalise on its strengths and skills of its composite members. There are no set models rather principles that will provide the foundations for a group which is supported to fulfil their specific purpose. The views of the PPI group will be presented at the quarterly Neuro-Oncology Multi-disciplinary team business meetings to provide a forum to discuss issues. We aim to foster a PPI friendly environment, deliver real engagement and involvement across the group.

Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS): A systematic review on variations in outcome reporting

Women pregnant with a breech-presenting fetus at term are at an increased risk of adverse outcomes. Although the most common intervention is planned delivery by caesarean section, this is not always possible or desirable. Comparing alternative interventions is difficult due to heterogeneity in reported outcomes and their measurements. Additionally, the evidence, particularly for women in labour with a breech-presenting fetus, is very low quality, with several outcomes viewed as critical and important to decision-making not reported at all. There is a need to develop a core outcome set of minimum outcomes in all studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth (Breech-COS).Our objectives were to (1) identify outcomes currently reported in effectiveness studies of breech birth at term using a systematic review of the literature; (2) assess the methodological quality of outcome reporting in the included studies; and (3) engage with members of an established Patient and Public Involvement (PPI) group about the results, to help frame our understanding from the perspective of service users.We searched three databases (MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials) for all effectiveness studies associated with vaginal breech birth published in English between 2000 and 2020. Two reviewers independently screened and extracted the data. Outcomes were categorised into neonatal, maternal, features of labour, and long-term maternal and hierarchy of outcome classification (primary, secondary, part of composite, or undesignated). Frequency of reporting was calculated for each. An adapted methodological assessment was done for each study investigating whether primary and secondary objectives were clearly stated and defined. The results of the systematic review were then discussed with a PPI group to consider importance and relevance to service users.A total of 211 outcomes were extracted from 108 included studies, comprising of short (43) and long-term (39) neonatal, short (54) and long-term (39) maternal and features of labour (36) outcomes. The most frequently reported outcome in each category was: APGAR score at 5 min, developmental vulnerability/neurological morbidity, maternal mortality, urinary incontinence, and actual mode of birth respectively. Long-term outcomes were infrequently reported in the included studies, with outcomes for future pregnancies not reported at all, although these were each deemed important by service users. There was a lack of consensus in definition and measurement of outcomes, with only 36% of the included studies having clearly stated primary and secondary objectives.The observed heterogeneity in reported outcomes, lack of consensus in definition and measurement, as well as desire expressed by service users to have robust risk statistics for outcomes important to them highlights the need to develop a core outcome set for evaluating effectiveness studies of breech birth at term. A Breech-COS will enable useful synthesis of evidence and contribute to supported decision-making for women pregnant with a breech-presenting fetus at term.

P21: PREVENTING DEHYDRATION IN LOOP ILEOSTOMY: RESULTS FROM A PPI GROUP TO ASSESS ACCEPTABILITY OF DAILY DOUBLE STRENGTH REHYDRATION SALTS (DIORALYTE™) AND PATIENT OPINIONS ON IMPORTANCE OF THIS AS AN AREA OF RESEARCH

Abstract Introduction Dehydration is a common problem amongst colorectal cancer patients who are defunctioned with loop ileostomy. This is known to lead to significant morbidity including acute kidney injury, hospital readmission and non-commencement or non-completion of chemotherapy. This institution plans to run a trial looking into preventing this with oral rehydration salts and formed a patient and public involvement (PPI) group to inform trial design and assess patient opinion on importance of this area of research. Method Five patients were recruited to the PPI group and a recorded semi-structured group interview was conducted. Patients were invited to try the rehydration salts and asked questions related to trial design and importance of research. The recording was transcribed and thematically analysed by the primary researcher. A consultant surgeon was present to ensure any medical issues raised were dealt with correctly. Result Three participants had experienced problems with their stoma. The main themes identified were; social embarrassment, behaviour modification, high outputs of stomas, fear of non-closure. The participants were unaware of dehydration related complications but felt that they were of high importance when provided with relevant information. Participants tasted the oral rehydration salts and expressed preference for mixing them with fruit flavoured squash. No specific barriers were identified in participation and patients were highly motivated to engage with the proposed study. Conclusion Patients are motivated and believe this to be a worthwhile area of research. Daily double strength rehydration salts are an acceptable intervention with few barriers to participation. Take-home message Dehydration in patients defunctioned with loop ileostomy is a significant cause of morbidity. Patients are highly motivated to engage in research into preventing this and find daily double strength rehydration salts is an acceptable intervention.

The role of patient and public involvement leads in facilitating feedback: \u201cinvisible work\u201d

BackgroundHealth research in the UK requires patients, those with lived experience and members of the public to be involved in designing and shaping research: many of them have reported that their comments and suggestions are not always acknowledged, and they do not know if their input has been used or is useful. The benefits of feedback from researchers not only create motivation for further involvement but aids learning and development, as well as recording impact. The aims of this study were to improve the feedback experience of Patient and Public Involvement (PPI) contributors. Co-produced feedback processes were designed and implemented in order to change feedback from researchers to PPI contributors in six PPI groups in England.MethodsAn explanatory mixed methods sequential study design was utilised with a comparative questionnaire survey (administered 20 months apart), interviews and a focus group with PPI leads, researchers and PPI contributors. Patient and Public Involvement contributors were involved from initial idea, study design, data analysis through to dissemination.ResultsCo-designed feedback processes were introduced in five of the six PPI groups and there was an overall increase in the frequency of feedback over the period studied. The enablers and barriers to implementing feedback processes were identified, which included the importance of wider institutional level support. PPI leads need to have dedicated time and acknowledge feedback as part of their role. The importance of individual feedback processes designed by, and for each PPI group, rather than a generic one, was also identified as key to successful implementation.ConclusionThe role of the PPI lead is an important facilitator in improving feedback but can easily be overlooked and has been described as invisible. PPI leads can perform an essential bridging role between researchers and members of the public. This study has shown that PPI feedback processes can be implemented if they are part of embedded PPI with explicit expectations, facilitated by a dedicated PPI lead role with sufficient support and resources. The findings have implications beyond this particular study, particularly for those involved in undertaking and funding health and social care research.