Improving the Detection, Assessment, Management and Prevention of Delirium in Hospices (the DAMPen-D study): Feasibility study of a flexible and scalable implementation strategy to deliver guideline-adherent delirium care.

BACKGROUND: Delirium is a complex condition, stressful for all involved. Although highly prevalent in palliative care settings, it remains underdiagnosed and associated with poor outcomes. Guideline-adherent delirium care may improve its detection, assessment and management. AIM: To inform a future definitive study that tests whether an implementation strategy designed to improve guideline-adherent delirium care in palliative care settings improves patient outcomes (reduced proportion of in-patient days with delirium). DESIGN: With Patient Involvement members, we conducted a feasibility study to assess the acceptability of and engagement with the implementation strategy by hospice staff (intervention), and whether clinical record data collection of process (e.g. guideline-adherent delirium care) and clinical outcomes (evidence of delirium using a validated chart-based instrument;) pre- and 12-weeks post-implementation of the intervention would be possible. SETTING/PARTICIPANTS: In-patient admissions in three English hospices. RESULTS: Between June 2021 and December 2022, clinical record data were extracted from 300 consecutive admissions. Despite data collection during COVID-19, target clinical record data collection (n = 300) was achieved. Approximately two-thirds of patients had a delirium episode during in-patient stay at both timepoints. A 6% absolute reduction in proportion of delirium days in those with a delirium episode was observed. Post-implementation improvements in guideline-adherent metrics include: clinical delirium diagnosis 15%-28%; delirium risk assessment 0%-16%; screening on admission 7%-35%. CONCLUSIONS: Collection of data on delirium outcomes and guideline-adherence from clinical records is feasible. The signal of patient benefit supports formal evaluation in a large-scale study.

High INtensity Interval Training in pATiEnts with Intermittent Claudication: A Qualitative Acceptability Study.

BACKGROUND: A novel high-intensity interval training (HIIT) program has demonstrated feasibility for patients with intermittent claudication (IC). The aim of this study was to explore patient perspectives of the HIIT program to inform refinement and future research. METHODS: All patients screened and eligible for the 'high intensity interval training in patients with intermittent claudication (INITIATE)' study were eligible to take part in a semistructured interview. A convenience subsample of patients was selected from 3 distinct groups: 1) those who completed the HIIT program, 2) those who prematurely discontinued the HIIT program, and 3) those who declined the HIIT program. Interviews considered patients views of the program and experiences of undertaking and/or being invited to undertake it. Interviews were audio recorded, transcribed verbatim, and analyzed via thematic analysis. RESULTS: Eleven out of 31 participants who completed the program and 12 out of 38 decliners were interviewed. No participants who withdrew from the program agreed to interview. The 3 key themes were; personal reflections of the program; program facilitators and barriers; and perceived benefits. Completers enjoyed taking part, reported symptomatic improvement and would complete it again. Practical and psychological barriers exist, such as transport and motivation. Changes to the program were suggested. CONCLUSIONS: Findings support the acceptability of this novel HIIT program, which in combination with the feasibility findings, suggest that a fully powered randomized controlled trial, comparing HIIT to usual-care supervised exercise programs is warranted.

Patient influence on general practice service improvement decision making: a participatory research mixed-methods intervention study.

BACKGROUND: Health policy promotes patient participation in decision making about service organisation. In English general practice this happens through contractually required patient participation groups (PPGs). However, there are problems with the enactment of PPGs that have not been systematically addressed. AIM: To observe how a co-designed theory-informed intervention can increase representational legitimacy and facilitate power sharing to support PPGs to influence decision making about general practice service improvement. DESIGN AND SETTING: Participatory action research to implement the intervention in two general practices in the North of England was undertaken. The intervention combined two different participatory practices: partnership working involving externally facilitated meetings with PPG members and staff; and consultation with the wider patient population using a bespoke discrete choice experiment (DCE). METHOD: To illustrate decision making in PPGs, qualitative data are presented from participant observation notes and photographed visual data generated through participatory methods. The DCE results are summarised to illustrate how wider population priorities contributed to overall decision making. Observational data were thematically analysed using normalisation process theory with support from a multi-stakeholder co-research group. RESULTS: In both general practices, patients influenced decision making during PPG meetings and through the DCE, resulting in bespoke patient-centred action plans for service improvement. Power asymmetries were addressed through participatory methods, clarification of PPG roles in decision making, and addressing representational legitimacy through wider survey consultation. CONCLUSION: Combining participatory practices and facilitated participatory methods enabled patients to influence decision making about general practice service improvement. The policy of mandatory PPGs needs updating to recognise the need to resource participation in a meaningful way.

Associations between physical activity, sedentary behaviour, and alcohol consumption among UK adults: Findings from the Health Behaviours during the COVID-19 pandemic (HEBECO) study.

INTRODUCTION: The COVID-19 pandemic and attendant lockdowns have had a substantial negative effect on alcohol consumption and physical activity globally. Pre-pandemic evidence in the adult population suggests that higher levels of physical activity were associated with higher levels of drinking, but it is unclear how the pandemic may have affected this. Therefore, this study aims to assess the association between alcohol consumption and physical activity in a UK cohort established during the COVID-19 pandemic. METHODS: Analyses utilized data from the Health Behaviours during the COVID-19 pandemic (HEBECO) study involving 2,057 UK adults (≥18 years). Participants completed self-report measures of alcohol consumption [frequency, quantity, frequency of heavy episodic drinking (HED) and AUDIT-C score] and physical activity [moderate-vigorous physical activity (MVPA), frequency of muscle strengthening activity (MSA) and sedentary behaviour] between November 2020 and January 2021. Ordinal logistic regression models were conducted, adjusting for sociodemographic factors. RESULTS: Fifteen percent of the sample reported abstinence from drinking. Overall, 23.4% of participants drank ≥4 times/week, 13.9% drank more than 6 units/single drinking occasion (HED), 7.5% reported HED daily/almost daily and 4.2% scored ≥11 on AUDIT-C. MSA 3 days/week compared with no MSA was significantly associated with higher odds of alcohol frequency [OR (95 CI%) = 1.41 (1.04-1.91)], quantity [OR (95 CI%) = 1.38 (1.02-1.87)], HED [OR (95 CI%) = 1.42 (1.05-1.94)] and possible dependence [OR (95 CI%) = 1.47 (1.05-2.06)]. The association of MVPA and sedentary behaviour with drinking measures was not significant (p>0.05). CONCLUSION: In contrast with previous research, MSA rather than aerobic physical activity was associated with increased alcohol consumption during the COVID-19 pandemic. It is conceivable that during lockdown while drinking was used as a coping strategy, limited opportunities for aerobic exercise made MSA a more convenient form of physical activity. To guide public health interventions, more research is required to examine the temporal relationship between different forms of physical activity and alcohol consumption.

High-intensity interval training in patients with intermittent claudication.

OBJECTIVE: Provision, uptake, adherence, and completion rates for supervised exercise programs (SEP) for intermittent claudication (IC) are low. A shorter, more time-efficient, 6-week, high-intensity interval training (HIIT) program may be an effective alternative that is more acceptable to patients and easier to deliver. The aim of this study was to determine the feasibility of HIIT for patients with IC. METHODS: A single arm proof-of-concept study, performed in secondary care, recruiting patients with IC referred to usual-care SEPs. Supervised HIIT was performed three times per week for 6 weeks. The primary outcome was feasibility and tolerability. Potential efficacy and potential safety were considered, and an integrated qualitative study was undertaken to consider acceptability. RESULTS: A total of 280 patients were screened: 165 (59%) were eligible, and 40 (25%) were recruited. The majority (n = 31; 78%) of participants completed the HIIT program. The remaining nine patients were withdrawn or chose to withdraw. Completers attended 99% of training sessions, completed 85% of sessions in full, and performed 84% of completed intervals at the required intensity. There were no related serious adverse events. Maximum walking distance (+94 m; 95% confidence interval, 66.6-120.8 m) and the SF-36 physical component summary (+2.2; 95% confidence interval, 0.3-4.1) were improved following completion of the program. CONCLUSIONS: Uptake to HIIT was comparable to SEPs in patients with IC, but completion rates were higher. HIIT appears feasible, tolerable, and potentially safe and beneficial for patients with IC. It may provide a more readily deliverable, acceptable form of SEP. Research comparing HIIT with usual-care SEPs appears warranted.

Embedding new technology into clinical ultrasound practice: Is role extension for sonographers the key to improving patient pathways?

Introduction: MicroUS is a new imaging technique that may have potential to reliably monitor prostate disease and therefore release capacity in MRI departments. Firstly, however, it is essential to identify which healthcare staff may be suitable to learn to use this modality. Based on previous evidence, UK sonographers may be well placed to harness this resource. Topic: Currently, there is sparse evidence on the performance of MicroUS for monitoring prostate disease but early findings are encouraging. Although its uptake is increasing, it is believed that only two sites in the UK have MicroUS systems and only one of those uses just sonographers to undertake and interpret this new imaging technique. Discussion: UK sonographers have a history of role extension dating back several decades and have proven repeatedly that they are reliable and accurate when measured against a gold standard. We explore the background of UK sonographer role extension and postulate that sonographers are best placed to adopt and embed new imaging techniques and technology into routine clinical practice. This is of particular importance given the dearth of ultrasound focussed radiologists in the UK. To effectively introduce challenging new work streams, multi-professional collaboration in imaging, alongside sonographer role extension, will ensure precious resources are maximised thus ensuring optimum patient care. Conclusion: UK sonographers have repeatedly demonstrated reliability in many areas of role extension in various clinical settings. Early data indicate that the adoption of MicroUS for use in prostate disease surveillance may be another role suited to sonographers.

Extracorporeal shockwave therapy compared with standard care for diabetic foot ulcer healing: An updated systematic review.

Emerging evidence suggests that extracorporeal shockwave therapy (ESWT) may improve time to DFU healing. The aim of this review was to appraise the evidence on role of ESWT in DFU healing and impact of different ESWT doses. Databases were searched for trials comparing ESWT plus standard care to standard care alone in participants with DFUs. Search results were reviewed by two independent reviewers. The Cochrane Risk of Bias 2 tool and GRADE approach was used to assess bias and certainty. The primary outcome was time to healing. The search identified 345 papers after duplicates removed. Six trials consisting of 471 participants were included. There was unclear or high risk of bias across all domains. Time to ulcer healing was probably shorter in patients treated with ESWT compared with standard ulcer care alone (GRADE: low certainty). Patients treated with ESWT were more likely to heal at 20 weeks post-ESWT compared with those treated with standard ulcer care alone (GRADE: low certainty). There was significant heterogeneity. ESWT remains a promising new treatment but the translation into routine clinical practice is still limited by the low certainty of evidence surrounding its effectiveness, case selection and optimum dose.

Recruiting to surgical trials in the emergency setting: using a mixed methods study to understand clinician and patient perspectives.

BACKGROUND: Undertaking randomized clinical trials (RCTs) in emergency surgical settings is associated with methodological and practical challenges. This study explored patients' and clinicians' perspectives associated with the conduct of an RCT comparing laparoscopic and open colorectal surgery in the acute setting. METHODS: All eligible patients screened and enrolled for the 'Laparoscopic versus open colorectal surgery in the acute setting (LaCeS)' multicentre, randomized clinical feasibility trial in five UK NHS Trusts were invited to respond to a survey. Patients and healthcare professionals were also invited to take part in semi-structured interviews. Survey and interviews explored the acceptability of the feasibility trial. Interviews were audio recorded, transcribed verbatim, and analysed using thematic analysis. Survey data were analysed descriptively to assess patient views of the trial and intervention. RESULTS: Out of 72 patients enrolled for the LaCeS RCT, survey data were collected from 28 patients (38.9 per cent), and interviews were conducted with 16 patients and 14 healthcare professionals. Thirteen out of 28 patients (46 per cent) had treatment preferences but these were not strong enough to deter participation. Twelve of the patients interviewed believed that their surgeon preferred laparoscopic surgery, but this did not deter them from participating in the trial. Half of the surgeons interviewed expressed the view that laparoscopic surgery was of benefit in this setting, but recognized that the need for research evidence outweighed their personal treatment preferences. Eight of the 14 recruiters reported that the emergency setting affected recruitment, especially in centres with fewer recruiting surgeons. Interviewees reported that recruitment was helped significantly by using surgical trainees to consent patients. CONCLUSION: This study identified specific challenges for the LaCeS trial design to address and adds significant insights to our understanding of recruiting to emergency surgical trials more broadly.

Mapping and characterising electronic palliative care coordination systems and their intended impact: A national survey of end-of-life care commissioners.

OBJECTIVES: In England, Electronic Palliative Care Coordination Systems (EPaCCS) were introduced in 2008 to support care coordination and delivery in accordance with patient preferences. Despite policy supporting their implementation, there has been a lack of rigorous evaluation of EPaCCS and it is not clear how they have been translated into practice. This study sought to examine the current national implementation of EPaCCS, including their intended impact on patient and service outcomes, and barriers and facilitators for implementation. METHODS: We conducted a national cross-sectional online survey of end-of-life care commissioning leads for Clinical Commissioning Groups (CCGs) in England. We enquired about the current implementation status of EPaCCS, their role in information sharing and intended impact, and requested routine patient-level data relating to EPaCCS. RESULTS: Out of 135 CCGs, 85 (63.0%) responded, with 57 (67.1%) having operational EPaCCS. Use of EPaCCS were confined to healthcare providers with most systems (67%) not supporting information sharing with care homes and social care providers. Most systems (68%) sought to facilitate goal concordant care, although there was inconsonance between intended impacts and monitoring measures used. Common challenges to implementation included healthcare professionals' limited engagement. Only one-third of patients had an EPaCCS record at death with limited recording of patient preferences. CONCLUSIONS: Critical gaps exist in engagement with EPaCCS and their ability to facilitate information sharing across care providers. The limited alignment between stated goals of EPaCCS and their monitoring impedes efforts to understand which characteristics of systems can best support care delivery.

Understanding the long-term impact of flooding on the wellbeing of residents: A mixed methods study.

As the effects of climate change become more visible, extreme weather events are becoming more common. The effects of flooding on health are understood but the long-term impact on the well-being of those affected need to be considered. This mixed methods secondary analysis of a cross-sectional survey examined the extent to which being flooded in the past is associated with ongoing concerns about flooding. Survey data were collected from residents in Hull 11 years after the initial flooding event. Respondents were asked about the floods in 2007 and their current level of concern about flooding. Ordinal logistic regression explored the effect of age and tenancy status as predictors of current concern. Textual data were analyzed using thematic content analysis. Responses were received from 457 households, of whom 202 (48%) were affected by flooding in 2007. A fifth of respondents were very concerned about future flooding. Those who were not flooded were significantly less concerned about the risk of future flooding (U = 33391.0, z = 5.89, p < 0.001). Those who reported negative health and wellbeing effects from the floods were significantly more concerned about future flooding than those whose health was not affected (U = 7830.5, z = 4.43, p < 0.001). Whilst some residents were reassured by the introduction of new flood alleviation schemes, others did not feel these were adequate, and worried about the impact of climate change. The financial and emotional impacts of the floods still resonated with families 11 years after the event, with many fearing they would not cope if it happened again. Despite the 2007 floods in Hull happening over a decade ago, many of those affected continue to experience high levels of anxiety when storms are forecast. Residents feel powerless to protect themselves, and many remain unconvinced by the presence of new flood alleviation schemes. However, with the ongoing threat of climate change, it may be that other residents are unrealistic in their expectation to be 'protected' from flood events. Therefore, public health agencies need to be able to mobilize organizations to come together to pro-actively support families affected by flooding, to ensure those in need do not fall through the gaps of public healthcare delivery.

Improving the Detection, Assessment, Management and Prevention of Delirium in Hospices (the DAMPen-D study): protocol for a co-design and feasibility study of a flexible and scalable implementation strategy to deliver guideline-adherent delirium care.

INTRODUCTION: Delirium is a complex condition in which altered mental state and cognition causes severe distress and poor clinical outcomes for patients and families, anxiety and stress for the health professionals and support staff providing care, and higher care costs. Hospice patients are at high risk of developing delirium, but there is significant variation in care delivery. The primary objective of this study is to demonstrate the feasibility of an implementation strategy (designed to help deliver good practice delirium guidelines), participant recruitment and data collection. METHODS AND ANALYSIS: Three work packages in three hospices in the UK with public involvement in codesign, study management and stakeholder groups: (1) experience-based codesign to adapt an existing theoretically-informed implementation strategy (Creating Learning Environments for Compassionate Care (CLECC)) to implement delirium guidelines in hospices; (2) feasibility study to explore ability to collect demographic, diagnostic and delirium management data from clinical records (n=300), explanatory process data (number of staff engaged in CLECC activities and reasons for non-engagement) and cost data (staff and volunteer hours and pay-grades engaged in implementation activities) and (3) realist process evaluation to assess the acceptability and flexibility of the implementation strategy (preimplementation and postimplementation surveys with hospice staff and management, n=30 at each time point; interviews with hospice staff and management, n=15). Descriptive statistics, rapid thematic analysis and a realist logic of analysis will be used be used to analyse quantitative and qualitative data, as appropriate. ETHICS AND DISSEMINATION: Ethical approval obtained: Hull York Medical School Ethics Committee (Ref 21/23), Health Research Authority Research Ethics Committee Wales REC7 (Ref 21/WA/0180) and Health Research Authority Confidentiality Advisory Group (Ref 21/CAG/0071). Written informed consent will be obtained from interview participants. A results paper will be submitted to an open access peer-reviewed journal and a lay summary shared with study site staff and stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN55416525.

The role of diagnostic ultrasound imaging for patients with known prostate cancer within an active surveillance pathway: A systematic review.

BACKGROUND: The use of multiparametric magnetic resonance imaging (mpMRI) within active surveillance of prostate cancer programmes is identified by the UK National Institute for Health and Care Excellence (NICE guideline NG 131 2019) as having a role for monitoring disease. The widespread demands on mpMRI capacity may limit its use in surveillance. It is therefore timely to review the options that modern ultrasound imaging present to this cohort of patients in the monitoring of prostate cancer. METHODS: Between April and September 2020, 10 databases were searched to recruit studies for the review. Three reviewers evaluated the publications for inclusion. Characteristics including the inclusion criteria for the study cohort, how disease was determined, identification of disease progression, and the modality and mode of imaging used were reviewed. Given the paucity of full text articles, a meta-analysis was not possible. A narrative review was undertaken. RESULTS: In total, 12 studies, utilising the range of ultrasound parameters of B-mode, micro-ultrasound, colour Doppler, contrast ultrasound and elastography were included. The review demonstrated that micro-ultrasound offers promise as an imaging tool comparable with mpMRI. However, this is an emerging technology with limited availability. Analysis of the data further demonstrated that by combining the diagnostic features provided by multiple modes reviewed, ultrasound has a role in the diagnostic imaging of patients on active surveillance. CONCLUSION: Providing a multiparametric approach is utilised, stable ultrasound findings may allow for increased intervals between biopsy for men on surveillance. The advent of micro-US offers promise as an imaging modality within an active surveillance pathway but requires further verification.

A rapid review and meta-regression analyses of the toxicological impacts of microplastic exposure in human cells.

Humans are exposed to microplastics (MPs) daily via ingestion and inhalation. It is not known whether this results in adverse health effects and, if so, at what levels of exposure. Without epidemiological studies, human cell in vitro MP toxicological studies provide an alternative approach to this question. This review systematically synthesised all evidence and estimated thresholds of dose-response relationships. MEDLINE and Web of Science were searched from inception to March 2021 and study quality was rated using a novel risk of bias assessment tool. Seventeen studies were included in the rapid review and eight in the meta-regression. Four biological endpoints displayed MP-associated effects: cytotoxicity, immune response, oxidative stress, barrier attributes, and one did not (genotoxicity). Irregular shape was found to be the only MP characteristic predicting cell death, along with the duration of exposure and MP concentration (µg/mL). Cells showed varying cytotoxic sensitivity to MPs, with Caco-2 cells (human adenocarcinoma cell line) being the most susceptible. Minimum, environmentally-relevant, concentrations of 10 µg/mL (5-200 µm), had an adverse effect on cell viability, and 20 µg/mL (0.4 µm) on cytokine release. This work is the first to quantify thresholds of MPs effects on human cells in the context of risk assessment.

Through-knee versus above-knee amputation for vascular and non-vascular major lower limb amputations.

BACKGROUND: Diabetes and vascular disease are the leading causes of lower limb amputation. Currently, 463 million adults are living with diabetes, and 202 million with peripheral vascular disease, worldwide. When a lower limb amputation is considered, preservation of the knee in a below-knee amputation allows for superior functional recovery when compared with amputation at a higher level. When a below-knee amputation is not feasible, the most common alternative performed is an above-knee amputation. Another possible option, which is less commonly performed, is a through-knee amputation which may offer some potential functional benefits over an above-knee amputation. OBJECTIVES: To assess the effects of through-knee amputation compared to above-knee amputation on clinical and rehabilitation outcomes and complication rates for all patients undergoing vascular and non-vascular major lower limb amputation. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases; the World Health Organization International Clinical Trials Registry Platform; and the ClinicalTrials.gov trials register to 17 February 2021. We undertook reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: Published and unpublished randomised controlled trials (RCTs) comparing through-knee amputation and above-knee amputation were eligible for inclusion in this study. Primary outcomes were uncomplicated primary wound healing and prosthetic limb fitting. Secondary outcomes included time taken to achieve independent mobility with a prosthesis, health-related quality of life, walking speed, pain, and 30-day survival. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed all records identified by the search. Data collection and extraction were planned in line with recommendations outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of evidence using the GRADE approach. MAIN RESULTS: We did not identify RCTs that met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: No RCTs have been conducted to determine comparative clinical or rehabilitation outcomes of through-knee amputation and above-knee amputation, or complication rates. It is unknown whether either of these approaches offers improved outcomes for patients. RCTs are needed to guide practice and to ensure the best outcomes for this patient group.

Prostate cancer: unmet supportive and palliative care needs: national survey of patients and family carers.

OBJECTIVES: Men living with prostate cancer have supportive and palliative needs. However, few studies detail unmet needs (vs quality of life measurement) or include data from those with advanced disease. We aimed to identify unmet needs of people living with prostate cancer (men, family carers), including those with advanced disease. METHODS: Mixed-methods national survey (patient Supportive Care Needs Survey; Carer Support Needs Assessment Tool) and health status (EuroQol Visual Analogue Scale). Quantitative data were explored using regression analysis. Free text data were subjected to thematic analysis. RESULTS: 216 men (mean age 65±8.5 years; active cancer 136 [63%]) and 97 carers (68 (70%) spouse/partner) provided data. 133 men (62%) reported moderate-to-high need which was more likely in advanced disease. Men's health status was worse with active vs remitted disease (mean difference -11; 95% CI -17 to -5; p<0.001). 85 (88%) carers reported at least one unmet need relating to 'enabling them to care' and 83 (86%) relating to 'their own well-being'. Carers with chronic illnesses had more unmet needs (p=0.01 to p=0.04) and patient receipt of palliative care independently predicted higher unmet carer needs (p=0.02).Free text data demonstrated widespread burden with: (1) poor communication/information, including about palliative care; (2) poorly managed symptoms/concerns and (3) poor care co-ordination. Incontinence, sexual dysfunction and hormone side-effects were serious problems, often left unaddressed. CONCLUSIONS: Many living with prostate cancer continue with wide-ranging concerns. Lack of systematic, ongoing needs assessment and poor communication compound inadequate clinical pathways. Person-centred care, interdisciplinary working and integrated palliative care should be resourced.

The unique information and communication needs of men affected by prostate cancer: A qualitative study of men's experience.

OBJECTIVE: The objective of this study is to explore the specific information and communication needs of men affected by prostate cancer to inform the development of educational materials for clinicians. METHODS: This is a qualitative descriptive study. A purposive sampling strategy was used to identify men at different cancer stages and with experience of different treatment regimens. Semistructured interviews (25) were conducted with 19 men and six carers over the phone. Interview data were analysed using a framework approach. RESULTS: Four themes emerged: gaps in the information provided by secondary care doctors and nurses, communication skills needed in effective clinical information provision, a need for individualised information and alternative information sources used to meet unmet needs. Regardless of cancer stage and treatment, men with prostate cancer and their carers found information regarding common and burdensome adverse effects of prostate cancer treatment particularly lacking, and their ongoing and changing information needs often overlooked. They needed information delivered in a compassionate and individually tailored manner, considering content, timing and emotional support within the context of their unique life circumstances. CONCLUSION: Clinicians often fail to recognise the need for or deliver patient-centred conversations about treatment, managing side effects and prognosis. The findings will be used to develop clinician-facing educational materials.

A mixed-method feasibility study of a novel transitional regime of incremental haemodialysis: study design and protocol.

BACKGROUND: Incremental haemodialysis/haemodiafiltration (HD) may help reduce early mortality rates in patients starting HD. This mixed-method feasibility study aims to test the acceptability, tolerance and safety of a novel incremental HD regime, and to study its impact on parameters of patient wellbeing. METHOD: We aim to enrol 20 patients who will commence HD twice-weekly with progressive increases in duration and frequency, achieving conventional treatment times over 15 weeks (incremental group). Participants will be followed-up for 6 months and will undergo regular tests including urine collections, bio-impedance analyses and quality-of-life questionnaires. Semi-structured interviews will be conducted to explore patients' prior expectations from HD, their motivations for participation and experiences of receiving incremental HD. For comparison of safety and indicators of dialysis adequacy, a cohort of 40 matched patients who previously received conventional HD will be constructed from local dialysis records (historical controls). RESULTS: Data will be recorded on the numbers screened and proportions consented and completing the study (primary outcome). Incremental and conventional groups will be compared in terms of differences in blood pressure control, interdialytic weight changes, indicators of dialysis adequacy and differences in adverse and serious adverse events. In analyses restricted to incremental group, measurements of RRF, fluid load and quality-of-life during follow-up will be compared with baseline values. From patient interviews, a narrative description of key themes along with anonymised quotes will be presented. CONCLUSION: Results from this study will address a significant knowledge gap in the prescription HD therapy and inform the development novel future therapy regimens.

The Development of a Multilevel Intervention to Optimise Participant Engagement with an Obesity Prevention Programme Delivered in UK children's Centres.

Poor participant engagement threatens the potential impact and cost-effectiveness of public health programmes preventing meaningful evaluation and wider application. Although barriers and levers to engagement with public health programmes are well documented, there is a lack of proven strategies in the literature addressing these. This paper details the development of a participant engagement intervention aimed at promoting enrolment and attendance to a community-based pre-school obesity prevention programme delivered in UK children's centres; HENRY (Health, Exercise, Nutrition for the Really Young). The Behaviour Change Wheel framework was used to guide the development of the intervention. The findings of a coinciding focused ethnography study identified barriers and levers to engagement with HENRY that informed which behaviours should be targeted within the intervention to promote engagement. A COM-B behavioural analysis was undertaken to identify whether capability, opportunity or motivation would need to be influenced for the target behaviours to occur. APEASE criteria were used to agree on appropriate intervention functions and behaviour change techniques. A multi-level participant engagement intervention was developed to promote adoption of target behaviours that were proposed to promote engagement with HENRY, e.g. ensuring the programme is accurately portrayed when approaching individuals to attend and providing 'taster' sessions prior to each programme. At the local authority level, the intervention aimed to increase buy-in with HENRY to increase the level of resource dedicated to engagement efforts. At the centre level, managers were encouraged to widen promotion of the programme and ensure that staff promoted the programme accurately. HENRY facilitators received training to increase engagement during sessions, and parents that had attended HENRY were encouraged to recruit their peers. This paper describes one of the first attempts to develop a theory-based multi-level participant engagement intervention specifically designed to promote recruitment and retention to a community-based obesity prevention programme. Given the challenges to implementing public health programmes with sufficient reach, the process used to develop the intervention serves as an example of how programmes that are already widely commissioned could be optimised to enable greater impact.

Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study.

PURPOSE: High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible. MATERIALS AND METHODS: We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned. RESULTS: We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months. CONCLUSION: A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL.

Microplastic Contamination of Seafood Intended for Human Consumption: A Systematic Review and Meta-Analysis.

BACKGROUND: Microplastics (MPs) have contaminated all compartments of the marine environment including biota such as seafood; ingestion from such sources is one of the two major uptake routes identified for human exposure. OBJECTIVES: The objectives were to conduct a systematic review and meta-analysis of the levels of MP contamination in seafood and to subsequently estimate the annual human uptake. METHODS: MEDLINE, EMBASE, and Web of Science were searched from launch (1947, 1974, and 1900, respectively) up to October 2020 for all studies reporting MP content in seafood species. Mean, standard deviations, and ranges of MPs found were collated. Studies were appraised systematically using a bespoke risk of bias (RoB) assessment tool. RESULTS: Fifty studies were included in the systematic review and 19 in the meta-analysis. Evidence was available on four phyla: mollusks, crustaceans, fish, and echinodermata. The majority of studies identified MP contamination in seafood and reported MP content <1 MP/g, with 26% of studies rated as having a high RoB, mainly due to analysis or reporting weaknesses. Mollusks collected off the coasts of Asia were the most heavily contaminated, coinciding with reported trends of MP contamination in the sea. According to the statistical summary, MP content was 0-10.5 MPs/g in mollusks, 0.1-8.6 MPs/g in crustaceans, 0-2.9 MPs/g in fish, and 1 MP/g in echinodermata. Maximum annual human MP uptake was estimated to be close to 55,000 MP particles. Statistical, sample, and methodological heterogeneity was high. DISCUSSION: This is the first systematic review, to our knowledge, to assess and quantify MP contamination of seafood and human uptake from its consumption, suggesting that action must be considered in order to reduce human exposure via such consumption. Further high-quality research using standardized methods is needed to cement the scientific evidence on MP contamination and human exposures. https://doi.org/10.1289/EHP7171.