Synthesising conceptual frameworks for patient and public involvement in research - A critical appraisal of a meta-narrative review

© 2018 The Author(s). Background: A number of conceptual frameworks for patient and public involvement (PPI) in research have been published in recent years. Although some are based on empirical research and/or existing theory, in many cases the basis of the conceptual frameworks is not evident. In 2015 a systematic review was published by a collaborative review group reporting a meta-narrative approach to synthesise a conceptual framework for PPI in research (hereafter 'the synthesis'). As the first such synthesis it is important to critically scrutinise this meta-narrative review. The 'RAMESES publication standards for meta-narrative reviews' provide a framework for critically appraising published meta-narrative reviews such as this synthesis, although we recognise that these were published concurrently. Thus the primary objective of this research was to appraise this synthesis of conceptual frameworks for PPI in research in order to inform future conceptualisation. Methods: Four researchers critically appraised the synthesis using the RAMESES publication standards as a framework for assessment. Data were extracted independently using a data extraction form closely based on the RAMESES publication standards. Each item from the standards was assessed on a four point scale (0 = unmet, 1 = minimally met, 2 = partly met, 3 = fully met). The four critical appraisals were then compared and any differences resolved through discussion. Results: A good degree of inter-rater reliability was found. A consensus assessment of the synthesis as a meta-narrative review of PPI conceptual frameworks was achieved with an average of '1' (minimally met) across all 20 items. Two key items ('evidence of adherence to guiding principles of meta-narrative review' and 'analysis and synthesis processes') were both wholly unmet. Therefore the paper did not meet our minimum requirements for a meta-narrative review. We found the RAMESES publication standards were a useful tool for carrying out a critical appraisal although some minor improvements are suggested. Conclusions: Although the aims of the authors' synthesis were commendable, and the conceptual framework presented was coherent and attractive, the paper did not demonstrate a transparent and replicable meta-narrative review approach. There is a continuing need for a more rigorous synthesis of conceptual frameworks for PPI

Working with public contributors in Parkinson's research: what were the changes, benefits and learnings? A critical reflection from the researcher and public contributor perspective

Introduction: This paper provides a critical reflection from both the researcher and public contributor (PC) perspective on the benefits and the learnings taken from involving PCs in research related to Parkinson's. Approach to Patient and Public Involvement (PPI): This paper reports on how PCs shaped the design and development of the PRIME‐UK research programme study materials through input into information leaflets, consent forms and other patient‐facing documents used across three studies within the PRIME‐UK research programme. The PRIME‐UK research programme is designed to improve the quality of life of people with Parkinson's and this project included three studies: a cross‐sectional study, a randomised control trial and a qualitative study. We captured these impacts using Public Involvement Impact Logs, which provide a framework allowing researchers and PCs to report on the learnings, immediate outcomes and impacts from PPI. For this project, the impact logs enabled us to provide reflections from PCs and researchers on the process of involving ‘the public’ in Parkinson's research. Findings: This paper builds on existing evidence of the range of benefits and challenges that emerge from working with patients and the public in Parkinson's research; this includes reflecting on the changes made to the study materials and benefits for the people involved. Four themes emerged from the reflections that were common to the researchers and PCs; these were the importance of providing a supportive environment; recognition of the benefit of the evaluation of the impact of PPI; acknowledgement that engagement of PPI can make a positive difference to the research process and that timely communication and the use of face‐to‐face communication, where available, is key. Furthermore, we demonstrate how impact logs provide a useful and straightforward tool for evaluating public involvement practices and supporting the feedback process. Conclusion: We offer key recommendations for involving patients and the public in Parkinson's research and suggest approaches that could be implemented to capture the impacts of public involvement. Public Contribution: Public contributors (PCs) were involved in the design and development of the participant information leaflets, consent forms and other patient‐facing documents used for studies within the PRIME‐UK research programme. In addition, PCs evaluated their involvement using impact logs and co‐authored this paper

Palliative care research centre's move into social media: constructing a framework for ethical research, a consensus paper

Background Social media (SM) have altered the way we live and, for many, the way we die. The information available on even the rarest conditions is vast. Free from restrictions of mobility, time and distance, SM provides a space for people to share experiences of illness, death and dying, and potentially benefit from the emotional and practical support of others n similar positions. The communications that take place in these spaces also create large amounts of ‘data’ which, for any research centre, cannot be ignored. However, for a palliative care research centre the use of this ‘data’ comes with specific ethical dilemmas. Methods This paper details the process that we, as a research, went through in constructing a set of ethical guidelines by which to work. This involved conducting two consensus days; one with researchers from within the centre, and one with the inclusion of external researchers with a specific interest in SM. Results The primary themes that emerged from the consensus meetings includes; SM as a public or private space; the status of open and closed groups; the use of historical data; recruiting participants and obtaining informed consent and problems of anonymity associated with dissemination. Conclusions These are the themes that this paper will focus on prior to setting out the guidelines that we subsequently constructed

Considerations and recommendations for conducting qualitative research interviews with palliative and end-of-life care patients in the home setting: a consensus paper

Objectives To present and discuss the views of researchers at an academic palliative care research centre on research encounters with terminally ill patients in the home setting and to generate a list of recommendations for qualitative researchers working in palliative and end-of-life care. Methods Eight researchers took part in a consensus meeting to discuss their experiences of undertaking qualitative interviews. The researchers were of varying backgrounds and all reported having experience in interviewing terminally ill patients, and all but one had experience of interviewing patients in their home environment. Results The main areas discussed by researchers included: whether participation in end-of-life research unintentionally becomes a therapeutic experience or an ethical concern; power relationships between terminally ill patients and researchers; researcher reflexivity and reciprocity; researchers’ training needs. Qualitative methods can complement the home environment; however, it can raise ethical and practical challenges, which can be more acute in the case of research undertaken with palliative and patients at the end-of-life. Conclusions The ethical and practical challenges researchers face in this context has the potential to place both participant and researcher at risk for their physical and psychological well-being. We present a set of recommendations for researchers to consider prior to embarking on qualitative research in this context and advocate researchers in this field carefully consider the issues presented on a study-by-study basis

Clonal expansion of community-associated meticillin-resistant Staphylococcus aureus (MRSA) in people who inject drugs (PWID)::Prevalence, risk factors and molecular epidemiology, Bristol, United Kingdom, 2012 to 2017

Background: In 2015, Bristol (South West England) experienced a large increase in cases of meticillin-resistant Staphylococcus aureus (MRSA) infection in people who inject drugs (PWID). Aim: We aimed to characterise and estimate the prevalence of MRSA colonisation among PWID in Bristol and test evidence of a clonal outbreak. Methods: PWID recruited through an unlinked-anonymous community survey during 2016 completed behavioural questionnaires and were screened for MRSA. Univariable logistic regression examined associations with MRSA colonisation. Whole-genome sequencing used lineage-matched MRSA isolates, comparing PWID (screening and retrospective bacteraemia samples from 2012-2017) with non-PWID (Bristol screening) in Bristol and national reference laboratory database samples. Results: The MRSA colonisation prevalence was 8.7% (13/149) and was associated with frequently injecting in public places (odds ratio (OR): 5.5; 95% confidence interval (CI):1.34–22.70), recent healthcare contact (OR: 4.3; 95% CI: 1.34–13.80) and injecting in groups of three or more (OR: 15.8; 95% CI: 2.51–99.28). People reporting any one of: injecting in public places, injection site skin and soft tissue infection or hospital contact accounted for 12/13 MRSA positive cases (sensitivity 92.3%; specificity 51.5%). Phylogenetic analysis identified a dominant clade associated with infection and colonisation among PWID in Bristol belonging to ST5-SCCmecIVg. Conclusions: MRSA colonisation in Bristol PWID is substantially elevated compared with general population estimates and there is evidence of clonal expansion, community-based transmission and increased infection risk related to the colonising strain. Targeted interventions, including community screening and suppression therapy, education and basic infection control are needed to reduce MRSA infections in PWID

Formal consensus study on surgery to replace the aortic valve in adults aged 18-60 years

Objective: There is uncertainty about surgical procedures for adult patients aged 18-60 years undergoing aortic valve replacement (AVR). Options include conventional AVR (mechanical, mAVR; tissue, tAVR), the pulmonary autograft (Ross) and aortic valve neocuspidisation (Ozaki). Transcatheter treatment may be an option for selected patients. We used formal consensus methodology to make recommendations about the suitability of each procedure. Methods: A working group, supported by a patient advisory group, developed a list of clinical scenarios across seven domains (anatomy, presentation, cardiac/non-cardiac comorbidities, concurrent treatments, lifestyle, preferences). A consensus group of 12 clinicians rated the appropriateness of each surgical procedure for each scenario on a 9-point Likert scale on two separate occasions (before and after a 1-day meeting). Results: There was a consensus that each procedure was appropriate (A) or inappropriate (I) for all clinical scenarios as follows: mAVR: total 76% (57% A, 19% I); tAVR: total 68% (68% A, 0% I); Ross: total 66% (39% A, 27% I); Ozaki: total 31% (3% A, 28% I). The remainder of percentages to 100% reflects the degree of uncertainty. There was a consensus that transcatheter aortic valve implantation is appropriate for 5 of 68 (7%) of all clinical scenarios (including frailty, prohibitive surgical risk and very limited life span). Conclusions: Evidence-based expert opinion emerging from a formal consensus process indicates that besides conventional AVR options, there is a high degree of certainty about the suitability of the Ross procedure in patients aged 18-60 years. Future clinical guidelines should include the option of the Ross procedure in aortic prosthetic valve selection

Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting):study protocol for a randomized controlled trial

Background: The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. Methods/Design: The study is a randomized multicenter phase III trial, with an internal pilot phase, comparing stent alone versus stent plus palliative radiotherapy in patients with incurable esophageal cancer. Eligible participants are those with advanced esophageal cancer who are in need of stent insertion for primary management of dysphagia. Radiotherapy will be administered as 20 Gray (Gy) in five fractions over one week or 30 Gy in 10 fractions over two weeks, within four weeks of stent insertion. The internal pilot will assess rates and methods of recruitment; pre-agreed criteria will determine progression to the main trial. In total, 496 patients will be randomized in a 1:1 ratio with follow up until death. The primary outcome is time to progression of patient-reported dysphagia. Secondary outcomes include survival, toxicity, health resource utilization, and quality of life. An embedded qualitative study will explore the feasibility of patient recruitment by examining patients’ motivations for involvement and their experiences of consent and recruitment, including reasons for not consenting. It will also explore patients’ experiences of each trial arm. Discussion: The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on patient-reported, rather than disease-orientated, outcomes. Exploration of patient experience and health economic analyses will be integral to the assessment of benefit for patients and the NHS

TACT: What impact does research partner involvement have on the working practices of a cancer clinical trials unit and academic research centre

From 2005, lay representatives (‘Research Partners-RPs) have been involved as memebers of the research team in a clinical trials unit, and more recently a Marie Curie facility. However, the impact of their work has not been routinely examined. The TACT study was designed as a means of evaluation