Patient And Public Involvement Group Research Articles

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.

'You've come to children that are in care and given us the opportunity to get our voices heard': The journey of looked after children and researchers in developing a Patient and Public Involvement group.

BackgroundLooked after children and care leavers (denoted as LAC) are often described as a ‘hard to reach' group of young people, and their voices are rarely sought to inform academic research.MethodsThis paper reports on experiences and reflections of a group of children and young people and academic researchers who developed a Patient and Public Involvement (PPI) group that was set up in the context of an ongoing health service intervention trial with LAC.Setting and participantsEighteen qualitative semi‐structured interviews were conducted with seven LAC, the participation officer within a North East Children in Care Council and the four researchers involved in developing and facilitating the PPI group. PPI sessions (n = 9) each approximately 1 hour in length were conducted over an 18‐month period.AnalysisThe qualitative interviews were transcribed verbatim. Thematic analysis was used to analyse the data, and direct quotes are used within the paper.Main outcomesThe LAC used the PPI group to produce a 5‐minute video to highlight why they think young people should be involved in research. Overall findings suggested that it was feasible to develop a research‐related PPI group with LAC. Findings from the research were used to co‐develop ‘top tips' of working with vulnerable young people such as looked after children.ConclusionThis paper has shown that PPI with LAC can be done if a co‐production approach to research is taken. It also suggests that assumptions regarding the capabilities of young people as researchers need to be re‐evaluated.

Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including 'acknowledgement of individual contribution', 'contributing for a collective benefit' and 'receiving accessible and easy to understand results'. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients' final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this Study Within A Trial (SWAT) is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-based approach to receiving trial results for participants in the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST), a trial of thyroxine versus placebo in people aged 65 years and older. Methods: Mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-based approach using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-based approach) and control group (standard approach developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two groups. Results: Participants want to receive results of clinical trials, with qualitative findings indicating three key themes including ‘acknowledgement of individual contribution’, ‘contributing for a collective benefit’ and ‘receiving accessible and easy to understand results’. Building on these findings, the patient-based approachwas developed. TRUST participants (n=101) were randomised to the intervention (n=51) or control group (n=50). The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two approaches. Conclusions: We have demonstrated that it is feasible to involve trial participants in the development of result dissemination materials. Although, in this study PPI did not influence patients’ understanding of results, it documents the process of conducting PPI within the clinical trial setting.

Patient involvement in qualitative data analysis in a trial of a patient-centred intervention: Reconciling lay knowledge and scientific method.

BackgroundWe conducted a pilot study of an intervention to facilitate patients’ agenda setting in clinical consultations. The primary aim of the study was to test the feasibility of running the randomized controlled trial. A secondary objective was to assess the extent to which patient and public involvement (PPI) could contribute to the process of qualitative data analysis (QDA).AimsTo describe a novel approach to including patient partners in QDA; to illustrate the kinds of contribution that patient partners made to QDA in this context; and to propose a characterization of a process by which patient involvement can contribute to knowledge production.MethodsSix patient and public representatives were supported to contribute to data analysis via a range of modalities. During a series of QDA workshops, experienced research staff role‐played consultations and interviews, and provided vignettes. Workshop data and PPI diaries were analysed using thematic discourse analysis.ResultsWe characterized a process of thesis, antithesis and synthesis. This PPI group contributed to the rigour and validity of the study findings by challenging their own and the researchers’ assumptions, and by testing the emerging hypotheses. By training PPI representatives to undertake qualitative data analysis, we transformed our understanding of doctor–patient consultations.ConclusionsThis research required changes to our usual research practices but was in keeping with the objective of establishing meaningful patient involvement for a future definitive trial. This work was informed by concepts of critical humility, and a process of knowledge production enabled via the construction of a knowledge space.

Reporting and appraising the context, process and impact of PPI on contributors, researchers and the trial during a randomised controlled trial - the 3D study

Plain English summaryIncluding patient and public involvement (PPI) in health research is thought to improve research but it is hard to be clear exactly how it helps. This is because PPI takes many forms, is sometimes only token and is not always reported clearly. This makes it difficult to combine the evidence so that clear conclusions can be reached about the ingredients of successful PPI and what PPI achieves. Previous research that has tried to combine the evidence has led to several guidelines for researchers to use in setting up and reporting PPI.This paper was written jointly by researchers and PPI contributors as a reflection on our experiences. The aim was to add to the evidence, by giving detail about the use of PPI in a large randomised controlled trial and the effect it had. We were guided by published PPI reporting guidelines. The effects on the trial are shown in a table of changes made because of suggestions from the PPI group. A survey was used to ask PPI contributors and researchers about their experience and effects they had noticed. Three themes were noted: impact on the trial, the effect of involvement on individual researchers and group members, and group environment. The PPI work affected the trial in many ways, including changes to documents used in the trial and advice on qualitative data collection methods and analysis. Individuals reported positive effects, including enjoying being in the group, gaining confidence, and learning how to share views.BackgroundPatient and public involvement (PPI) is believed to enhance health care delivery research, and is widely required in research proposals. Detailed, standardised reporting of PPI is needed so that strategies to implement more than token PPI that achieves impact can be identified, properly evaluated and reproduced. Impact includes effects on the research, PPI contributors and researchers. Using contributor and researcher perspectives and drawing on published guidelines for reporting PPI, we aimed to reflect on our experience and contribute evidence relevant to two important questions: ‘What difference does PPI make?’ and ‘What’s the best way to do it?’MethodsFourteen people living with multiple long-term conditions (multimorbidity) were PPI contributors to a randomised controlled trial to improve care for people with multimorbidity. Meetings took place approximately four times a year throughout the trial, beginning at grant application stage. Meeting notes were recorded and a log of PPI involvement was kept. At the end of the trial, seven PPI contributors and four researchers completed free-text questionnaires about their experience of PPI involvement and their perception of PPI impact. The responses were analysed thematically by two PPI contributors and one researcher. The PPI group proposed writing this report, which was co-authored by three PPI contributors and two researchers.ResultsMeeting attendance averaged nine PPI contributors and three to four researchers. The involvement log and meeting notes recorded a wide range of activities and impact including changes to participant documentation, advice on qualitative data collection, contribution to data analysis and dissemination advice. Three themes were identified from the questionnaires: impact on the study, including keeping the research grounded in patient experience; impact on individuals, including learning from group diversity and feeling valued; and an environment that facilitated participation. The size of the group influenced impact. Researchers and PPI contributors described a rewarding interaction that benefitted them and the research.ConclusionsPPI was wide-ranging and had impact on the trial, contributors and researchers. The group environment facilitated involvement. Feedback and group interactions benefitted individuals. The insights gained from this study will postitively influence the researchers’ and contributors’ future involvement with PPI.

Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including 'acknowledgement of individual contribution', 'contributing for a collective benefit' and 'receiving accessible and easy to understand results'. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients' final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

Beyond lip service and box ticking: how effective patient engagement is integral to the development and delivery of patient-reported outcomes.

In the UK, demonstration of patient and public involvement (PPI) is now a funding requirement. Despite advice being available to researchers regarding PPI, levels of engagement are variable. Patient involvement has been at the core of the Leeds Psychosocial Oncology and Clinical Practice Research Group since 2007 when a local Research Advisory Group (RAG) was established. In addition, we work with experienced patient advocates from national groups. The RAG is led by designated researchers who manage and communicate with members. The RAG is invited to twice yearly meetings with the full research team when study findings are disseminated and advice sought. The meetings are also an opportunity to socialise and thank members. Effective partnerships and engagement require good communication, building relationships over time and tailoring involvement to individuals' skills and experience. Patients have been involved in design, planning new projects and assisting with grant proposals; development, pilot testing of interview strategies and question generation, project steering groups and management teams, development of self-management advice for online patient portals; implementation, extensive beta testing of new questionnaire builder software to enable collection of online patient-reported outcomes (PRO) and study websites, cognitive interviews to develop PRO items; dissemination, co-authorship of papers and presentations, attendance/representation of the group at conferences. The involvement of patient advocates is integral to ensuring PRO development remains patient-centred. Having a co-operative, well-established local PPI group and nationally active patient collaborators has had a rewarding and significant impact on our research programmes.

OP0246-PARE Patients and Researchers Sometimes Think Alike: Patient Involvement in the Development of Quality Indicators for Osteoarthritis Care

BackgroundPeople with osteoarthritis (OA) desire high quality care, support and information about OA. Quality indicators (QI) can set minimum standards of quality of care for OA. Following a literature review,...