Nottingham City Council

Background Indwelling urinary catheters are drainage devices inserted into the bladder and are held in place by an inflatable balloon. The use of urinary catheters, while essential to bladder management, places the user at risk of catheter-associated urinary tract infections. Prevention of such infections in long-term catheter users could improve quality of life, and antimicrobial catheters may be more cost-effective compared with current plain catheters. We have developed and extensively characterised an indwelling antimicrobial urinary catheter impregnated with rifampicin, sparfloxacin and triclosan. We aimed to assess the effect of the antimicrobial urinary catheter on the number of catheter-associated urinary tract infections, blockages, unscheduled catheter changes, quality of life and resource use compared to usual care, over a 1-year period. We also aimed to assess the relative long-term safety, acceptability and cost-effectiveness of the novel catheter compared to current practice. Methods Before the clinical trial could be undertaken, the antimicrobial catheters had to be manufactured and validated by an industry partner in a multistage process. Validation included impregnation, accelerated ageing and biocompatibility testing. Progress and challenges Extensive device testing methods were developed and validated, including methods for determining the antimicrobial content of the catheters, detection of residual solvents and for an accelerated ageing process. A randomised clinical trial protocol was developed in parallel, in conjunction with patient advocates. A Trial Steering Committee was convened and a network of urology clinics created. The most significant challenge was that the industry partner was unable to consistently manufacture antimicrobial urinary catheters to the product specification. Much closer oversight of manufacturers processing the catheters is necessary to ensure compliance with protocols. The regulatory requirements for the novel catheters were also more extensive than anticipated and are subject to change. Delays accrued from these challenges, and there was uncertainty around the ability of the industry partner to produce a catheter. Ultimately, the project funder withdrew the funding before the clinical trial commenced. Conclusion Catheter-associated urinary tract infections remain a serious problem, especially to long-term urinary catheter users, and there is currently no effective prophylactic strategy. Protocols for validation of impregnation and sterilisation steps for biocompatibility testing and accelerated ageing studies have been established and can be applied to future manufacture of antimicrobial urinary catheters. A protocol for a randomised trial of such medical device has been developed and can be deployed once a antimicrobial urinary catheter has been correctly manufactured. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation programme as award number NIHR127982.

Coronavirus disease-2019 was associated with significant mortality and morbidity in care homes in 2020-1. Repurposed antiviral drugs might reduce morbidity and mortality through reducing viral transmission, infection, replication and inflammation. We aimed to compare the safety and efficacy of potential antiviral drugs in care home residents. We designed a cluster-randomised, open-label, blinded end-point platform trial to test drugs in a postexposure prophylaxis paradigm. Participants aged 65+ years from United Kingdom care homes, with or without nursing, were eligible for participation. Care homes were to be allocated at random by computer to administer 42 days of antiviral agent (ciclesonide or niclosamide) plus standard care versus standard care alone to residents. The primary outcome at 60 days after randomisation comprised the most serious outcome, which was defined as all-cause mortality, all-cause hospitalisation, severe acute respiratory syndrome coronavirus 2 infection or no infection. Analysis would be by intention to treat using ordinal logistic regression. Other outcomes included individual components of the primary outcome, transmission, plus health economic and process evaluation outcomes. The planned sample size was 300 care homes corresponding to 9600 residents. With ~40% of care homes predicted to develop an outbreak during the trial, we needed to recruit 750 homes/24,000 residents. We initiated the trial including protocol, approvals, insurance, website, database, data algorithms, intervention selection and training materials. We built a network of principal investigators and staff (91) and care homes (299) to support the trial. However, we never contracted care homes or general practitioners since the trial was stopped in September 2021, as vaccination in care homes had significantly reduced infections. Multiple delays significantly delayed the start date, such as: (1) reduced prioritisation of pandemic trials in 2021; (2) cumbersome mechanisms for choosing the investigational medicinal products; (3) contracting between National Institute for Health and Care Research and the investigational medicinal product manufacturers; (4) publicising the investigational medicinal products; (5) identification of sufficient numbers of care homes; (6) identification and contracting with several thousand general practitioners; (7) limited research nurse availability and (8) identification of adequate insurance to cover care homes for research. Generic challenges included working across the four home nations with their different structures and regulations. The feasibility of contracting between the sponsor and the principal investigators, general practitioners and care homes; screening, consent and treatment of care home residents; data acquisition and the potential benefit of postexposure prophylaxis were never tested. The success of vaccination meant that the role of postexposure prophylaxis of coronavirus disease-2019 in care home residents was not tested. Significant progress was made in developing the infrastructure and expertise necessary for a large-scale clinical trial of investigational medicinal products in United Kingdom care homes. The role of postexposure prophylaxis of coronavirus disease-2019 in care home residents remains undefined. Significant logistical barriers to conducting research in care homes need to be removed urgently before future studies are possible. Further work is required to develop the infrastructure for clinical trials of investigational medicinal products in care homes. Serious consideration should be given to building and then hibernating a pandemic-ready platform trial suitable for care home research. This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR133443.

Older people living in the community are at risk of preventable nighttime falls. Technology can support falls interventions but there is a lack of research into this area. A new bedside device called Bide senses movement and changes in light levels and plays a prerecorded message encouraging the user to follow falls prevention advice when trying to mobilise at night. To test the feasibility of using the Bide device in a community health service. Healthcare workers were trained in the use of the Bide device and asked to identify potential participants. The research team subsequently recruited participants, provided them with a device and explained how to use it. After four weeks, participants took part in face-to-face semi-structured interviews regarding the acceptability of the device. Participants' fear of falling was calculated before and after the intervention using the Falls Efficacy Scale-International. The Bide device appeared to increase patients' confidence to mobilise at night and no adverse events were reported from its use. The device was generally found to be acceptable and easy to use, although one participant found it irritating. Healthcare workers flagged up very few potential participants to the research team, which may have been due to workload pressures and a disconnect between healthcare workers and technology. It appears feasible to study the use of the Bide device for nighttime falls prevention in the community. To enhance recruitment, a member of the research team may be embedded in the clinical team with the aim of proactively identifying potential participants.

A faecal immunochemical tests (FIT) cut-off of ≥10 μg Hb/g faeces is now recommended in the UK as a gateway to urgent (suspected cancer) investigation for colorectal cancer (CRC), based on an expected CRC risk threshold of 3%. To quantify the risk of CRC at FIT cut-offs by age, haemoglobin and platelet strata. A cohort study of a symptomatic CRC pathway based on primary care FIT tests in Nottingham, UK (November 2017-2021) with 1-year follow-up. Heat maps showed the cumulative 1-year CRC risk using Kaplan-Meier estimates. In total, 514 (1.5%) CRCs were diagnosed following 33,694 index FIT requests. Individuals with a FIT ≥ 10 μg Hb/g faeces had a >3% risk of CRC, except patients under the age of 40 years (CRC risk 1.45% [95% CI: 0.03%-2.86%]). Non-anaemic patients with a FIT < 100 μg Hb/g faeces had a CRC risk of <3%, except those between the age of 70 and 85 years (5.26% 95% CI: 2.72%-7.73%). Using a ≥3% CRC threshold in patients <55 years calculated using FIT, age and anaemia might allow 160-220 colonoscopies per 10,000 FITs to be re-purposed, at a cost of missing 1-2 CRCs. FIT alone with a single cut-off is unlikely to be a panacea for optimising CRC diagnosis, as risk varies by FIT, age and anaemia when faecal haemoglobin levels are below 100 μg Hb/g. Tailored FIT cut-offs for investigation on a CRC pathway could reduce the number of investigations needed at a 3% CRC risk threshold.

Abstract Introduction Clinicians are often required to decide about patients’ potential to respond to rehabilitation. ‘Rehabilitation potential’ can determine what services patients can access. In acute hospitals clinicians have limited time to assess and deliver rehabilitation which takes into account the complexities of frailty and ageing. We set out to evaluate whether the Rehabilitation Potential Assessment Tool (RePAT)—a 15 item assessment tool and training package which emphasises person-centred approaches—was feasible and could aid rehabilitation decisions. Method A non-randomised feasibility study with nested semi-structured interviews, set in the acute hospital, explored whether RePAT was deliverable and acceptable to staff, patient and carers. A maximum variation sample of physiotherapists and occupational therapists was recruited. Patient and carer participants were recruited from Healthcare of Older People wards. Staff and patient characteristics were summarised using descriptive statistics. Interview data were analysed thematically. Fidelity of completed RePAT items was assessed on how closely they matched tool guidance by two reviewers. Mean values of the two scores were calculated. Results Six staff participants were recruited and trained, and assessed a total of 26 patient participants using RePAT. Mean patient age was 86.16 (±6.39) years. 32% were vulnerable or mildly frail, 42% moderately frail and 26% severely or very severely frail using the Clinical Frailty Scale. Mean time to complete RePAT was 32.7 (±9.6) minutes. 13 out of 15 RePAT items achieved fidelity. RePAT was acceptable and tolerated by staff and patients. Staff participants reported RePAT enabled them to consider the complex and dynamic nature of rehabilitation decisions in a more structured and consistent way. Conclusion RePAT was found to be acceptable and tolerated by staff, carers and patients. It allowed clinicians to make explicit their reasoning behind rehabilitation potential decision-making and encouraged them to become more cognisant of ethical dilemmas and biases.

Nottingham is both the birthplace and the global centre of the machine-made lace industry and is home to the Nationally Designated collection of machine-made lace and machinery. In 2017 Lace Unravelled was launched with the aim to conserve the collection and connect with local ‘industry mentors’ to learn more about its objects. This led to wider collaborations and the exhibition ‘Lace Unarchived’, held at Nottingham Trent University intended to reveal the legacy of the art school, established in 1843, and its impact on the generations of lace designers it educated. This paper proposes to explore the project’s achievements, what it revealed, and what it has meant for the interpretation and understanding of the collection, and wider understanding of ‘Nottingham Lace’.

"The essential guide to using cognitive behaviour therapy with children and young people." Educational Psychology in Practice, 36(2), pp. 225–226

This article discusses the history of natalizumab (Tysabri), the first monoclonal antibody used to treat multiple sclerosis. It reviews how the medication's difficult beginnings and controversial past have changed how this treatment is monitored. The article looks at the role of clinicians in maintaining patient safety, the benefits and risk profile of this treatment and ways of optimising practice to provide gold standard nationalised natalizumab services throughout the UK.