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BackgroundResearch is essential for gathering evidence to inform best practice and clinical decision making, for developing and testing new treatments and services in palliative and end-of-life care (PEoLC). The participation of patients, carers and family members is essential, however, personal and ethical concerns are often cited by professionals as barriers to recruitment. There is evidence that patients and family members can benefit from participation in PEoLC research.AimTo synthesise the evidence regarding patients’, family members’ and carers’ experiences of participating in PEoLC research. To identify recommendations for enhancing the experience of participants.DesignA qualitative rapid review and thematic synthesis.Data sourcesMEDLINE, PsycINFO and PubMed were searched from 2010 to 2020. Studies reporting patients’, family members’ or carers’ experiences of participating in PEoLC research were included.Results4 studies were included and 7 themes identified relating to the benefits of, and barriers to, participation in PEoLC research. Both altruistic and personal benefits of participation were reported. Barriers (negative aspects) to participation included feeling overwhelmed, practical issues, reminders of being a patient, not seeing the research as relevant to them and unmet needs.ConclusionsA number of benefits (positive aspects) surround participation in PEoLC research. However, several barriers (negative aspects) can prevent or discourage participation. This review has identified recommendations for research teams to enhance the experience, and number of people who those participating in research in this field.

IntroductionAs dementia progresses, care needs increase leading many to require 24-h care in care homes. eHealth interventions have the potential to improve care processes of assessment and decision-making for people with dementia. However, little is known on the acceptability and effectiveness in care homes.AimTo identify and explore the components, acceptability and effectiveness of eHealth interventions for people with dementia, families and staff to support assessment and decision-making in care homes.MethodsA mixed methods systematic review using narrative synthesis. Four databases were searched (Embase, PsycINFO, MEDLINE, and CINAHL) from 2000 to July 2021. Quality appraisal used validated assessment tools appropriate for the study design.ResultsTwenty-six studies met eligibility criteria. Study designs and interventions were heterogeneous. Overall quality was high to moderate. Interventions that promoted supportive, practical learning through integrated working and provided staff with language to communicate resident symptoms were favored by staff. We found evidence that indicated residents were willing to use video consultations; however, families preferred face-to-face consultations. Fifteen studies considered effectiveness. Use of eHealth interventions indicates an improvement in resident outcomes in appropriate prescribing and advance care planning. Staff knowledge, confidence, and wellbeing were also improved. Hospitalisations were reduced when a video consultation component was implemented.DiscussionCare home staff require support to meet the often multiple and changing care needs of residents with dementia. eHealth interventions can improve outcomes for staff and residents and facilitate integrated working with external professionals to support assessment and management of care. Further work is required to understand acceptability for residents and their families and effectiveness on family outcomes, particularly in non-Western cultures and low-middle income countries.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=254967, identifier: CRD42021254967.

Chronic obstructive pulmonary disease (COPD) treatment guidelines do not currently include recommendations for escalation directly from monotherapy to triple therapy. This 12-week, double-blind, double-dummy study randomized 800 symptomatic moderate-to-very-severe COPD patients receiving tiotropium (TIO) for ≥3 months to once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mcg via ELLIPTA (n = 400) or TIO 18 mcg via HandiHaler (n = 400) plus matched placebo. Study endpoints included change from baseline in trough forced expiratory volume in 1 s (FEV1) at Days 85 (primary), 28 and 84 (secondary), health status (St George’s Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT]) and safety. FF/UMEC/VI significantly improved trough FEV1 at all timepoints (Day 85 treatment difference [95% CI] 95 mL [62–128]; P

This chapter provides a case study on the use of a virtual world as the predominant mechanism for interacting with university students. In the Autumn Semester 2020, 49 engineering students partook in weekly seminars with teachers and each other on a fantastical virtual teaching island, known as Nottopia. The majority of students accessed the virtual world on desktop computers, although four routinely used their own VR headsets. Survey data indicated that the student experience was extremely positive and motivation to learn was very high. Interviews, together with video observations, established that five themes dictated the positive outcome, namely the design of the space, the nature of the integral content, the prevailing group dynamics, the role of avatars, and the magical interactions possible. These themes are realised in an initial design framework.

Simulators are widely used for investigating driving behavior under a variety of conditions. Simulators can provide a high level of relative validity, but levels of absolute validity are questionable. One drawback of simulator studies is the knowledge of participants that they are in an artificial scenario rather than driving on a real road with real consequences for performance and safety. This influences participants’ feelings of presence. There are many factors that influence presence, or the perceived ‘reality’ of a test environment, and in this paper two are discussed in detail: incentives and instructions. The use of incentives to encourage participation in research studies is inconsistent and there are many associated ethical and practical issues. Research papers rarely include descriptions of the instructions given to participants at the start of a study; however, the content and presentation of instructions can have an effect on participants’ behaviours. A methodology for a proposed study to investigate the influence of these factors in a driving simulator environment is also provided. Finally, some hypotheses for the study, based on the theory in this area, are presented for future testing.

This volume was planned prior to the COVID-19 pandemic as the North Carolina Institute of Medicine (NCIOM) completed a yearlong task force on serious illness. Beyond the task force report, we wanted to dedicate a special edition of the NCMJ to serious illness issues. We commissioned authors who could discuss the challenges, the current practices, and the extensive personal and professional skills needed to navigate these complicated medical diagnoses that often end in death. Little did we know how timely this would be in light of the current pandemic, and we can only speculate on how the world will look as this is published. Our pre-COVID planning reflected personal experiences we all face with the common denominator of serious illness impacting and shaping our lives. As guest editors, we considered how this NCMJ edition would address personal concerns for you, our reader, as well as ourselves. A physician, a social worker, and a nurse, we each have our stories and we want to invite you to lean in and bring both your head and your heart to this reading. We start by relating two very personal experiences that shaped not only life following loss, but also career choices, clinical practices, and scholarship. As you focus on this journal's content, we hope you will also reflect on the people you care for, as well as the issues we all inevitably face.

BACKGROUND: Acutely ill and frail older adults have complex social and health care needs. It is important to understand how this complexity affects acute outcomes for admission to hospital. We validated a frailty index using routine admission laboratory tests with outcomes after patients were admitted to hospital. METHODS: In a prospective cohort of older adults admitted to a large tertiary hospital in the United Kingdom, we created a frailty index from routine admission laboratory investigations (FI-Laboratory) linked to data comprising hospital outcomes. We evaluated the association between the FI-Laboratory and total days spent in hospital, discharge to a higher level of care, readmission and mortality. RESULTS: Of 2552 admissions among 1750 older adults, we were able to generate FI-Laboratory values for 2254 admissions (88.3% of the cohort). More than half of admitted patients were women (55.3%) and the mean age was 84.6 (SD 14.0) years. We found that the FI-Laboratory correlated weakly with the Clinical Frailty Scale (CFS; r2 = 0.09). An increase in the CFS and the equivalent of 3 additional abnormal laboratory test results in the FI-Laboratory, respectively, were associated with an increased proportion of inpatient days (rate ratios [RRs] 1.43, 95% confidence interval [CI] 1.35–1.52; and 1.47, 95% CI 1.41–1.54), discharge to a higher level of care (odd ratios [ORs] 1.39, 95% CI 1.27–1.52; and 1.30, 95% CI 1.16–1.47) and increased readmission rate (hazard ratios [HRs] 1.26, 95% CI 1.17–1.37; and 1.18, 95% CI 1.11–1.26). Increases in the CFS and FI-Laboratory were associated with increased mortality HRs of 1.39 (95% CI 1.28–1.51) and 1.45 (95% CI 1.37–1.54), respectively. INTERPRETATION: We determined that FI-Laboratory, distinct from baseline frailty, could be used to predict risk of many adverse outcomes. The score is therefore a useful way to quantify the degree of acute illness in frail older adults.

There are a number of factors which may influence the validity of experimental studies, including the incentives offered and the instructions provided to participants. These have been little-studied in the driving domain. The aim of this study was to investigate how manipulating these factors influenced participants’ feelings of ‘presence’ (i.e. the extent to which they believed they were actually driving and not in a simulated environment). The findings showed that imposing a penalty system for poor driving performance and providing ‘good driving’ instructions did not significantly affect presence ratings. This has a number of plausible explanations, including research study participants’ inherent need to perform well under test conditions and the small range of performance variability expected in a normal driving scenario. The financial penalty resulted in slightly slower speeds, although none of the participants drove excessively quickly, supporting the argument that study participants tend to perform diligently under test conditions irrespective of incentives or instructions. Participants in the penalty and instructions conditions gave higher ratings for negative effects (related to physically feeling unwell), suggesting that these conditions made them more aware of the physical symptoms of being in a simulator (but not that participants were actually experiencing more sickness). The results can be viewed positively in terms of reliability and generalizability across different driving simulator studies, as variations in study design (i.e. how instructions are delivered to participants and whether participants are paid to participate) do not have a significant effect on performance.

This study sought to understand the social value to University students of engaging universally in a virtual environment throughout a taught module. In a series of weekly seminars throughout September-December 2020, 49 undergraduate and postgraduate Engineering students interacted with module convenors and each other within a virtual teaching island (termed ‘Nottopia’) to consolidate learning from pre-recorded lectures. Questionnaire results highlighted the positive impact this innovative form of teaching had on the cohort, as the overwhelming majority felt highly motivated to participate in class activities and felt connected to their peers and lecturers. Objective data backed up these findings as attendance at the optional seminars was 90-100% throughout the semester. Follow-up interviews with students and behavioural observations identified five themes elucidating why such benefits accrue from the use of VR in this educational context: 1) A shared, student-owned and purposive space was provided; 2) content was inherently highly spatial/3D; 3) natural group dynamics arose in activities; 4) students could express their identity and/or hide using their chosen/designed avatar; 5) many magical and informative interactions were possible. These themes are realized in an initial framework which can aid educators in considering the different ways in which VR can affect the socially oriented experience of their students.

Evidence to support clinical decision making must be based on safety data that have been captured, analysed and interpreted in a robust and reliable way. Randomised real-world evidence (RRWE) studies provide the opportunity to evaluate the use of medicines in patients and settings representative of routine clinical practice. However, elements that underpin the design of RRWE studies can have a significant impact upon the analysis, interpretation and implications of safety data. In this narrative review, we use data from the Salford Lung Study; two prospective, 12-month, open-label, parallel-group, phase III randomised controlled trials conducted in primary care in the UK; to highlight the importance of capturing treatment modifications when attempting to evaluate safety events according to actual treatment exposure. We demonstrate that analysing safety data by actual treatment received (i.e. accounting for the treatment modifications that occur routinely in the primary care setting) provides additional insight beyond analysing according to randomised treatment strategy only. It is therefore proposed that understanding of safety data from RRWE trials can be optimised by analysing both by randomised group and by actual treatment received., Using results from the Salford Lung Study, this review demonstrates that the understanding of safety data from randomised real-world evidence studies can be optimised by analysing both actual treatment received and randomisation group https://bit.ly/3p7zPXU

Background: SLS COPD was the first open-label randomised controlled trial demonstrating a reduction in moderate/severe COPD exacerbations with once-daily inhaled fluticasone furoate/vilanterol (FF/VI) in everyday clinical practice. Here we report FF/VI effectiveness and safety in predefined patient subgroups. Methods: Patients with COPD, exacerbation history, and receiving maintenance inhaler therapy, were randomised to initiate FF/VI 100/25 μg or continue usual care (UC) with 12 months’ follow-up. Annual rates of moderate/severe exacerbations (primary outcome), selected secondary outcomes, and incidence of pneumonia serious adverse events of special interest (SAESI) were compared between randomisation groups across various patient subgroups/baseline treatment strata. SAESI rates by actual treatment were also assessed. Results: Lower exacerbation rates were observed for FF/VI versus UC across all subgroups/strata, including ICS + LABA therapy subset (8.0% [0.1, 15.4]), except in patients without baseline airflow limitation (−0.5% [–29.8, 22.1]). Larger reductions compared to the overall analysis were observed for patients on ICS-containing regimens (excluding LAMA) before the study (15.6% [3.4, 26.3]), and with baseline CAT score

Active safety systems have the potential to reduce the risk to pedestrians by warning the driver and/or taking evasive action to reduce the effects of or avoid a collision. However, current systems are limited in the range of scenarios they can address using primary control interventions, and this arguably places more emphasis in some situations on warning the driver so that they can take appropriate action in response to pedestrian hazards. In a counterbalanced experimental design, we varied urgency (‘when’) based on the time-to-collision (TTC) at which the warning was presented (with associated false-positive alarms, but no false negatives, or ‘misses’), and modality (‘how’) by presenting warnings using audio-only and audio combined with visual alerts presented on a HUD. Results from 24 experienced drivers, who negotiated an urban scenario during twelve 6.0-min drives in a medium-fidelity driving simulator, showed that all warnings were generally rated ‘positively’ (using recognised subjective ‘acceptance’ scales), although acceptance was lower when warnings were delivered at the shortest (2.0 s) TTC. In addition, drivers indicated higher confidence in combined audio and visual warnings in all situations. Performance (based on safety margins associated with critical events) varied significantly between warning onset times, with drivers first fixating their gaze on the hazard, taking their foot off the accelerator, applying their foot on the brake, and ultimately bringing the car to a stop further from the pedestrian when warnings were presented at the longest (5.0 s) TTC. In addition, drivers applied the brake further from the pedestrian when combined audio and HUD warnings were provided (compared to audio-only), but only at 5.0 s TTC. Overall, the study indicates a greater margin of safety associated with the provision of earlier warnings, with no apparent detriment to acceptance, despite relatively high false alarm rates at longer TTCs. Also, that drivers feel more confident with a warning system present, especially when it incorporates auditory and visual elements, even though the visual cue does not necessarily improve hazard localisation or driving performance beyond the advantages offered by auditory alerts alone. Findings are discussed in the context of the design, evaluation and acceptance of active safety systems.

Lady Annie Brassey (1839–1887) was a well-known Victorian travel writer who was also a collector, photographer, ethnographer, zoologist, and botanist and who traveled around the world aboard the privately owned yacht the Sunbeam. During these voyages she amassed a collection of approximately six thousand objects. Much more than tourist souvenirs, the collection shows a rigorous academic understanding of the disciplines she was collecting within. The ethnographic material, which makes up one-third of the collection, has gained little attention. Using her travel writing as a primary source, this article will interrogate Brassey’s role as the maker of this collection, someone whose class allowed her to travel and to pursue museum collection, curation, and education to a near-professional level. Through three case studies this article will consider how she collected and curated her own museum and used her collection for public benefit.

Introduction In the IMPACT trial, single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduced moderate/severe exacerbation rates versus FF/VI or UMEC/VI dual therapy in patients with chronic obstructive pulmonary disease (COPD); however, pneumonia incidence was higher in FF-containing arms. As COPD is a growing problem in Asia, we compared the efficacy and safety of FF/UMEC/VI in Asia versus non-Asia regions. Methods IMPACT was a double-blind, 52-week trial in symptomatic COPD patients with ≥ 1 moderate/severe exacerbation in the prior year. This pre-specified analysis evaluated the annual rate of moderate/severe exacerbations, change from baseline in trough forced expiratory volume in 1 s, and St George’s Respiratory Questionnaire total score, mortality, and safety (including pneumonia) in Asia versus non-Asia regions. Results The intent-to-treat population comprised 10,355 patients (Asia n = 1644 [16%]). Rate ratios (95% confidence intervals) for moderate/severe exacerbations with FF/UMEC/VI were 0.89 (0.76–1.05) versus FF/VI and 0.86 (0.71–1.04) versus UMEC/VI in Asia, and 0.84 (0.79–0.90) and 0.74 (0.68–0.80) in non-Asia. Efficacy of FF/UMEC/VI on other endpoints was similar in both regions. There was an increased incidence of investigator-reported pneumonia in patients in Asia (FF/UMEC/VI: 13%; FF/VI: 14%; UMEC/VI: 6%) compared with non-Asia (FF/UMEC/VI: 6%; FF/VI: 5%; UMEC/VI: 4%). The increased risk of pneumonia in patients in Asia was most marked in patients with lower body mass index, lower lung function, and taking inhaled corticosteroids. In post hoc analysis of adjudicated on-treatment all-cause mortality, probabilities of death were numerically lower in both regions with FF/UMEC/VI (Asia: 1.16%; non-Asia: 1.35%) and FF/VI (Asia: 1.77%; non-Asia: 1.21%) versus UMEC/VI (Asia: 1.91%; non-Asia: 2.23%). Conclusions FF/UMEC/VI provides similar benefits in COPD patients in Asia and non-Asia regions. Clinical benefits of treatment, including reduction in mortality risk, should be weighed against risk of pneumonia, taking account of all known risk factors. Trial Registration ClinicalTrials.gov identification, NCT02164513. Electronic supplementary material The online version of this article (10.1007/s41030-020-00136-3) contains supplementary material, which is available to authorized users.

Currently, the visual demand incurred by vehicle displays is evaluated using time criteria (such as those provided by NHTSA). This 60-participant driving simulator study investigated to what extent glance time criteria applies to Head-up Display (HUD) imagery, considering 48 locations across the windshield (and 3 in-vehicle display positions). Participants were required to make a long controlled continuous glance to a sample of these locations. Consequently, the time at which lateral/longitudinal unsafe driving occurred (e.g. deviating out of lane, unacceptable time to collision) could then be assessed. Using the selected measures, the results suggest that drivers are able to maintain driving performance for longer than recommended NHTSA guidelines for in-vehicle displays whilst engaging with HUD imagery in various locations. Importantly, the data from this study provides initial maps for designers highlighting the visual demand implications of HUD imagery across the windshield.

Involvement of those with experience of using care services is now an important and mandatory part of health and social care research, including palliative and end of life care. Those with direct experience of using palliative and end of life care (patients, carers, friends or family members), such as hospices and care homes can enhance and shape research (Goodman et al., 2011). The distinction is made between ‘participants’ in studies who provide ‘data’ and research carried out ‘with’ or ‘by’ members of the public (as defined by INVOLVE). Involvement in these research areas, has its own challenges (Backhouse et al., 2016; Mockford et al., 2016) and innovative approaches are needed (Brighton et al., 2018). Seeking involvement from people with experience of care at an early stage of research development is key to ensure the research is user-friendly, feasible and has relevant outcomes. Three organisations ran a joint workshop focussing on palliative and end of life care to enable researchers to receive face to face comments from people with experience of palliative and end of life care on their research projects in a ‘dragon’s den’ style session. We will share 1) our experience of this approach to involvement, 2) the experiences of the people who took part and 3) findings from the post evaluation. We will also outline the challenges of involving people in this research area, the importance of ‘feedback’ to those taking part (Mathie et al, 2018) and our learning for the future.

Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.