Establishing a set of research priorities in care homes for older people in the UK: a modified Delphi consensus study with care home staff

Background: currently, there is little evidence base for much of the care provided for older people in care homes. Given the wide range of topics that require further investigation, and limited resources, one solution is to identify the priorities for future research. Methods: a modified Delphi technique was used to identify research topics and develop consensus among care home staff participants. The survey was conducted across three rounds. Firstly to elicit topics that were considered by participants to require further research, secondly to prioritise the long list of research questions, followed by a third round to reach a consensus on the highest ranked 15 questions. Results: eighty-three participants responded to the initial survey, providing 144 questions. Following analysis and review against existing evidence, 76 research questions remained. Of note, 40/83 participants responded to the interim prioritisation round and 43/83 participants responded to the final round, which ranked the top 15 research questions by importance. Two other groups of health and social care professionals also participated in the final ranking. The results from these groups had a similar ordering to those of the original cohort of participants. Conclusion: this is the first study to establish a set of research priorities for older people in the UK care homes. It is hoped that sharing these results with clinicians, researchers and funding bodies will help to begin the process of ensuring that the future research agenda can be focused on the areas of greatest need. Further work to identify the priorities of other key stakeholders is required

Site visits to initiate recruitment in a clinical trial: Does it matter who conducts the visit? Protocol for implementation in trials

The Study Within A Trial (SWAT) programme exists to ‘embed research within research, so as to resolve uncertainties about the different ways of designing, conducting, analysing and interpreting evaluations of health and social care’ (1). Published in this journal in 2013, a template for the first SWAT protocol outlined an investigation into the effects of site visits by the Principal Investigator on recruitment in multi-centre randomized controlled trials (1). We have now designed a SWAT protocol to extend this question and ask ‘does it matter who conducts the site visit?’ Our aim is to provide a protocol which trials can implement to address this research question

Development of a measure to assess the quality of proxy decisions about research participation on behalf of adults lacking capacity to consent : the Combined Scale for Proxy Informed Consent Decisions (CONCORD scale)

Acknowledgements We would like to thank the participants who generously volunteered their time to participate in the interviews and the lay advisory group who provide invaluable insight and support for this research programme. Funding This study was conducted as part of a National Institute of Health Research Advanced Fellowship (CONSULT) held by VS and funded by the Welsh Government through Health and Care Research Wales (NIHR-FS(A)-2021). The funding body did not participate in the study design, data collection, analysis, or interpretation in writing this manuscript. Primary and Emergency Care (PRIME) Research Centre Wales) is funded by the Welsh Government through Health and Care Research Wales and the Centre for Trials Research is funded by Health and Care Research Wales and Cancer Research UK.Peer reviewedPublisher PD

Constructing authentic decisions: proxy decision making for research involving adults who lack capacity to consent

Research involving adults who lack capacity to consent relies on proxy (or surrogate) decision making. Proxy decisions about participation are ethically complex, with a disparity between normative accounts and empirical evidence. Concerns about the accuracy of proxies’ decisions arise, in part, from the lack of an ethical framework which takes account of the complex and morally pluralistic world in which proxy decisions are situated. This qualitative study explored the experiences of family members who have acted as a research proxy in order to develop an understanding of the ethical concepts involved, and the interactions between those concepts. Proxies described a complex process of respecting the wishes and preferences of the person they represented, whist integrating preferences with what they viewed as being in the interests of the person. They aimed to make a decision that was ‘best’ for the person and protected them from harm; they also aimed to make the ‘right’ decision, viewed as being authentic to the person’s values and life. Decisions were underpinned by the relationship between the person and their proxy, in which both trust and trustworthiness were key. Proxies’ decisions, based both on respect for the person and the need to protect their interests, arose out of their dual role as both proxy and carer. The findings raise questions about accounts which rely on existing normative assumptions with a focus on accuracy and discrepancy, and which fail to take account of the requirement for proxies to make authentic decisions that arise out of their caring obligations

Establishing the international prevalence of self-reported child maltreatment: a systematic review by maltreatment type and gender

Background Estimating the prevalence of child maltreatment is challenging due to the absence of a clear ‘gold standard’ as to what constitutes maltreatment. This systematic review aims to review studies using self-report maltreatment to capture prevalence rates worldwide. Methods PubMed, Ovid SP and grey literature from the NSPCC, UNICEF, The UK Government, and WHO from 2000 to 2017 were searched. The literature review focused on the variation found in self-reported lifetime prevalence for each type of maltreatment between studies by continent and gender, and how methodological differences may explain differences found. Results Sexual abuse is the most commonly studied form of maltreatment across the world with median (25th to 75th centile) prevalence of 20.4% (13.2% to 33.6%) and 28.8% (17.0% to 40.2%) in North American and Australian girls respectively, with lower rates generally for boys. Rates of physical abuse were more similar across genders apart from in Europe, which were 12.0% (6.9% to 23.0%) and 27.0% (7.0% to 43.0%) for girls and boys respectively, and often very high in some continents, for example, 50.8% (36.0% to 73.8%) and 60.2% (43.0% to 84.9%) for girls and boys respectively in Africa. Median rates of emotional abuse were nearly double for girls than boys in North America (28.4% vs 13.8% respectively) and Europe (12.9% vs 6.2% respectively) but more similar across genders groups elsewhere. Median rates of neglect were highest in Africa (girls: 41.8%, boys: 39.1%) and South America (girls: 54.8%, boys: 56.7%) but were based on few studies in total, whereas in the two continents with the highest number of studies, median rates differed between girls (40.5%) and boys (16.6%) in North America but were similar in Asia (girls: 26.3%, boys: 23.8%). Conclusions Median prevalence rates differ substantially by maltreatment category, gender and by continent. The number of studies and available data also varies and relatively little is known about prevalence for some forms of maltreatment, particularly outside of the North American context. Prevalence rates require caution in interpretation as some variation will reflect methodological differences, including the data collection methods, and how the maltreatment is defined

Unpacking the 'black box of horrendousness': a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent

Background Trials involving adults who lack capacity to consent encounter a range of ethical and methodological challenges, resulting in these populations frequently being excluded from research. Currently, there is little evidence regarding the nature and extent of these challenges, nor strategies to improve the design and conduct of such trials. This qualitative study explored researchers’ and healthcare professionals’ experiences of the barriers and facilitators to conducting trials involving adults lacking capacity to consent. Methods Semi-structured interviews were conducted remotely with 26 researchers and healthcare professionals with experience in a range of roles, trial populations and settings across the UK. Data were analysed using thematic analysis. Results A number of inter-related barriers and facilitators were identified and mapped against key trial processes including during trial design decisions, navigating ethical approval, assessing capacity, identifying and involving alternative decision-makers and when revisiting consent. Three themes were identified: (1) the perceived and actual complexity of trials involving adults lacking capacity, (2) importance of having access to appropriate support and resources and (3) need for building greater knowledge and expertise to support future trials. Barriers to trials included the complexity of the legal frameworks, the role of gatekeepers, a lack of access to expertise and training, and the resource-intensive nature of these trials. The ability to conduct trials was facilitated by having prior experience with these populations, effective communication between research teams, public involvement contributions, and the availability of additional data to inform the trial. Participants also identified a range of context-specific recruitment issues and highlighted the importance of ‘designing in’ flexibility and the use of adaptive strategies which were especially important for trials during the COVID-19 pandemic. Participants identified a need for better training and support. Conclusions Researchers encountered a number of barriers, including both generic and context or population-specific challenges, which may be reinforced by wider factors such as resource limitations and knowledge deficits. Greater access to expertise and training, and the development of supportive interventions and tailored guidance, is urgently needed in order to build research capacity in this area and facilitate the successful delivery of trials involving this under-served population

Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials

Background: Nocebo effects (‘negative placebo’ effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets (or elsewhere). Misattributing nocebo effects to the medicinal intervention can lead to participants experiencing harmful nocebo effects and may result in distortion of adverse effect reporting. However, little is known about how information on potential side effects is provided to trial participants. There is increasing concern that the way in which potential side effects in clinical trials are described to patients in participant information leaflets (PIL) can in itself cause harm by either increased anxiety, poor adherence or inducing the side effect itself. In this study, we aimed to explore these concerns and identify the way in which potential side effects from investigational medicinal products used in trials are presented in written information to potential participants. Methods: Trials were identified from the International Standard Randomised Controlled Trials Number (ISRCTN) clinical trial registry (a primary registry of the WHO International Clinical Trials Registry Platform (ICTRP)). Eligible studies were placebo-controlled clinical trials of investigational medicinal products (IMP) in adults conducted in the UK. We assessed readability using the Flesch Reading Ease scale, Gunning-Fog Index and Flesch-Kincaid Grade. Data extracted from the PILs were divided into 8 predefined qualitative themes for analysis in NVivo11. Results: Most of the patient information leaflets were ranked as ‘fairly difficult to read’ or ‘difficult to read’ according to the Flesch Reading Ease scale. All studies presented information about adverse events, whereas only a third presented information about intervention benefits. Where intervention or study benefits were presented, they were usually after adverse events (21/33, 64%). Discussion: Participant information leaflets scored poorly on ease of readability and had more content relating to adverse effects than any potential beneficial effects. The way in which adverse events were presented was heterogeneous in terms of their likelihood and severity and the amount and level of detail provided. By comparison, potential benefits from the intervention and/or study were described less often, by shorter text, and only after information about harms. Keywords: Nocebo, Placebo, Patient information leaflets, Adverse effects, Readabilit

‘It’s not making a decision, it’s prompting the discussions’: a qualitative study exploring stakeholders’ views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE)

Background Health and care research involving people who lack capacity to consent requires an alternative decision maker to decide whether they participate or not based on their ‘presumed will’. However, this is often unknown. Advance research planning (ARP) is a process for people who anticipate periods of impaired capacity to prospectively express their preferences about research participation and identify who they wish to be involved in future decisions. This may help to extend individuals’ autonomy by ensuring that proxy decisions are based on their actual wishes. This qualitative study aimed to explore stakeholders’ views about the acceptability and feasibility of ARP and identify barriers and facilitators to its implementation in the UK. Methods We conducted semi-structured interviews with 27 researchers, practitioners, and members of the public who had participated in a preceding survey. Interviews were conducted remotely between April and November 2023. Data were analysed thematically. Results Participants were supportive of the concept of ARP, with differing amounts of support for the range of possible ARP activities depending on the context. Six main themes were identified: (1) Planting a seed – creating opportunities to initiate/engage with ARP; (2) A missing part of the puzzle – how preferences expressed through ARP could help inform decisions; (3) Finding the sweet spot – optimising the timing of ARP; (4) More than a piece of paper – finding the best mode for recording preferences; (5) Keeping the door open to future opportunities – minimising the risk of unintended consequences; and (6) Navigating with a compass – principles underpinning ARP to ensure safeguarding and help address inequalities. Participants also identified a number of implementation challenges, and proposed facilitative strategies that might overcome them which included embedding advance research planning in existing future planning processes and research-focused activities. Conclusions This study provides a routemap to implementing ARP in the UK to enable people anticipating impaired capacity to express their preferences about research, thus ensuring greater opportunities for inclusion of this under-served group, and addressing the decisional burden experienced by some family members acting as proxies. Development of interventions and guidance to support ARP is needed, with a focus on ensuring accessibility

Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT) : protocol for a randomised Study Within a Trial

Acknowledgements We would like to thank the lay advisory group who provide invaluable insight and support for this research programme. Funding This research was funded by Health and Care Research Wales as part of an NIHR Advanced Fellowship (NIHR-FS(A)-2021). For the purpose of open access, the author has applied a Creative Commons Attribution (CC BY) licence to any Author Accepted Manuscript version arising. Primary and Emergency Care (PRIME) Research Centre Wales) is funded by the Welsh Government through Health and Care Research Wales and the Centre for Trials Research is funded by Health and Care Research Wales and Cancer Research UK. © 2022. The Author(s).Peer reviewedPublisher PD

Determining patient and primary care delay in the diagnosis of cancer – lessons from a pilot study of patients referred for suspected cancer

<p>Abstract</p> <p>Background</p> <p>There is no validated way of measuring diagnostic delay in cancer, especially covering patient and primary care delays. An instrument is needed in order to determine the effect of potential interventions to reduce delay and improve cancer morbidity and mortality.</p> <p>Methods</p> <p>Development of a postal questionnaire tool to measure patient and primary care time responses to key symptoms and signs. The pilot questionnaire was sent to 184 patients with suspected cancer.</p> <p>Results</p> <p>The response rate was only 85/184 (46.2%). Anxiety was cited as one reason for this low response. Patients returning questionnaires were more likely to be women and more likely to be younger. 84/85 (98.8%) provided consent to access medical records, and questions regarding health profile, smoking and socio-economic profile were answered adequately. Outcome data on their cancer diagnosis was linked satisfactorily and the question about GP-initiated investigations was answered well. Estimated dates for symptom duration were preferred for patient delays, but exact dates were preferred for primary care delays; however there was a significant amount of missing data.</p> <p>Conclusion</p> <p>A more personal approach to the collection of data about the duration of symptoms in this group of people is needed other than a postal questionnaire. However elements of this piloted questionnaire are likely to figure strongly in future development and evaluation of this tool.</p