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In this pragmatic trial, patients with asthma who required first-line controller therapy or were already using an inhaled glucocorticoid and needed additional therapy received a leukotriene-receptor antagonist (LTRA) or an inhaled glucocorticoid as first-line treatment or an LTRA or a long-acting beta 2 -agonist as an add-on. Results of double-blind, randomized, controlled trials provide, appropriately, the bedrock of evidence in determining the efficacy of therapeutic interventions. Proof of efficacy in the trial setting of optimized adherence and follow-up for selective patient populations does not, however, guarantee that a particular therapy will be effective in the diverse patient populations seen in clinical practice. 1 – 3 In the case of asthma, for example, the eligibility criteria in most such trials exclude an estimated 95% of patients with a current diagnosis of asthma, including smokers and those who have “insufficient” bronchodilator reversibility or impaired pulmonary function. 4 , 5 Moreover, the design of . . .

Background Influenza (flu) vaccination rates of Care home staff (CHS) in England are consistently lower (≈ 15% in 2023) than World Health Organisation recommendations (≥ 75%). The FluCare trial examined the effectiveness of a multi-component intervention (including on-site flu vaccination clinics, information materials including video, £850 incentive and monthly monitoring with feedback) designed to address known barriers to flu vaccine uptake amongst CHS. This paper reports an embedded process evaluation designed to understand implementation of the FluCare intervention and provide explanations for observed effects in the trial. Methods The FluCare cluster randomised controlled trial was conducted between November 2022 and March 2023. A mixed methods process evaluation was conducted employing questionnaires, semi-structured interviews, video analytics (no. clicks and duration of view) and clinic logs (no. clinics delivered, days/time clinics were delivered, and no. staff vaccinated). CHS (including managers) and vaccination providers (pharmacists, nurses and general practitioners) were purposively and conveniently selected, respectively, for the interviews. Descriptive statistics were obtained for quantitative data, and qualitative data were analysed thematically. Results FluCare intervention implementation varied across Care homes (CHs), with clinics and videos not being implemented in 35% and 43% of the intervention CHs respectively. In addition, clinic days and times varied depending on provider (pharmacy or general practice) and CH. Partial intervention implementation was partly influenced by managers’ engagement and sub-organisational cultures marked by negative narratives around vaccines. Contextual barriers included delivery of clinics late in the flu season. A greater indication of implementation fidelity was positively associated with change in staff attitudes and behaviours, with some getting vaccinated for the first time. Conclusions Variation in implementation of the FluCare intervention provides an explanation for detecting a difference where the intervention was fully implemented in the main trial. Manager and leader engagement is vital for both successful implementation and staff engagement. Avoidable contextual barriers, such as late timing of clinics, must be addressed to enhance flu vaccination uptake by CHS. More work is needed to understand the role of CH leaders in influencing intervention implementation, sub-organisational cultures and vaccination attitudes. Trial registration ISRCTN22729870. Registered on 24 August 2022.

BackgroundWhile almost half of older adults admitted to hospital are prescribed potentially inappropriate medicines, less than 1% have a medicine proactively deprescribed during admission in the UK. The CompreHensive geriAtRician-led MEdication Review (CHARMER) intervention is designed to address geriatricians’ and pharmacists’ barriers and enablers to deprescribing. The CHARMER definitive trial will evaluate effectiveness, cost-effectiveness and safety.MethodsA stepped-wedge cluster randomised controlled trial will be conducted in 20 hospitals in England, with four hospitals in reserve. All hospitals will collect baseline data. Every 3 months, five hospitals will be randomised to receive the intervention. The intervention, implemented by a local project manager, comprises a hospital action plan to set deprescribing as an organisational goal; workshops for pharmacists and geriatricians to change beliefs about deprescribing; weekly briefings between geriatricians and pharmacists to discuss opportunities for deprescribing; benchmarking reports to compare deprescribing performance across participating hospitals. With an average of 200 patients admitted and discharged during each step, the study will have 89.5% power at 5% significance level and intra-class correlation coefficient of 0.05 to detect a 3% difference in 90-day re-admission rate from 16.7% versus 13.7%. Anonymised routinely collected data, including readmissions, will be obtained for all patients admitted during the study period. Enhanced data collection periods of 1 month during control and intervention periods will be used to recruit patients and data for secondary outcomes and process evaluation.DiscussionA stepped-wedge design enabled a smaller number of hospitals and patients to be included than a traditional cluster-randomised design. The complexity of intervention implementation necessitated a project manager in addition to the principal investigator responsible for trial conduct. Using routinely collected data for the primary outcome measure should ensure that the trial has sufficient power on completion. Planned enhanced data collection for short periods of time improves trial efficiency.Trial registration numberISRCTN13248281.

Aim This study aims to explore the feasibility of using serial MRI without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot, in order to decide whether a large-scale trial is warranted. Methods A multicentre, randomised, prospective, two arm, open, feasibility study (CADOM) of people with diabetes with a suspected or confirmed diagnosis of Charcot neuroarthropathy. Participants were randomised (1:1) to ‘standard care plus’, including repeated foot temperature measurements and X-rays, or the intervention arm, with additional three-monthly MRI, until remission of Charcot neuroarthropathy or a maximum 12 months (active phase). Participants were then followed-up for a further 6 months, post remission to monitor for relapse of the Charcot neuroarthropathy (follow-up phase). Feasibility outcomes were recruitment, retention, data completeness, adherence to study procedures and safety of the intervention MRI. We also collected clinical efficacy outcomes, this included time in cast/off-loading device which will be the primary outcome of a future definitive trial. Finally, we collected patient reported outcomes, and data on health and social care usage. Results One-hundred and five people were assessed for eligibility at five sites. 64/105 potential participants meet the eligibility criteria to participate in the study. Forty-three participants were randomised: 20 to standard care plus and 23 to MRI intervention. The main reason for ineligibility was a previous episode of Charcot neuroarthropathy. Thirteen participants were withdrawn post-randomisation due to an alternative diagnosis being made. Of the remaining 30 participants, 19 achieved remission, 6 had not gone into remission at the end of the 12 month active phase so exited the study. Five participants were lost to follow-up. Of the MRIs that were not disrupted by COVID-19 pandemic 26/31 (84%) were completed. For the visits that were conducted face-to-face, completion rates of patient-reported outcome measures were between 71 and 100%. There were no safety incidents associated with the intervention MRI. As this was a feasibility study it was not designed to test the effectiveness of serial MRI in diagnosing remission. The time in cast/off-loading device was 235 (±108.3) days for the standard care plus arm compared to 292 (±177.4) days for the intervention arm. There was no statistical difference in the time in cast/off-loading device between the two arms of the study: Hazard Ratio (HR) 0.405 (95% CI 0.140–1.172), p  = 0.096. Discussion The findings support a definitive randomised controlled trial to evaluate the effectiveness of MRI in diagnosing remission in Charcot neuroarthropathy. The rates of recruitment, retention, data, and MRI completeness show that a definitive study is feasible. Study registration ISRCTN, 74101606 . Registered on 6 November 2017.

Background Influenza (flu) vaccination rates in UK care home staff are extremely low. Less than 40% of staff in care homes are vaccinated for influenza (flu), presenting risks to the health of frail residents and potential staff absence from cross-infection. Staff often do not perceive a need for vaccination and are unaware they are entitled to free flu vaccination. The FluCare study, a cluster randomised control trial (RCT), uses behavioural interventions to address barriers. Videos, posters, and leaflets are intended to raise awareness of flu vaccination benefits and debunk myths. On-site staff vaccination clinics increase accessibility. Financial incentives to care homes for improved vaccination rates and regular monitoring influence the environment. This paper outlines the planned process evaluation which will describe the intervention’s mechanisms of action, explain any changes in outcomes, identify local adaptations, and inform design of the implementation phase. Methods/design A mixed method process evaluation to inform the interpretation of trial findings. Objectives • Describe the intervention as delivered in terms of dose and fidelity, including adaptations and variations across care homes. • Explore the effects of individual intervention components on primary outcomes. • Investigate the mechanisms of impact. • Describe the perceived effectiveness of relevant intervention components (including videos, leaflets, posters, and flu clinics) from participant perspectives (care home manager, care home staff, flu clinic providers). • Describe the characteristics of care homes and participants to assess reach. A purposive sample of twenty care homes (ten in the intervention arm, ten in the control arm) for inclusion in the process evaluation. Data will include (1) study records including care home site profiles, (2) responses to a mechanism of action questionnaire, and (3) semi-structured interviews with care home staff and clinic providers. Quantitative data will be descriptively reported. Interview data will be thematically analysed and then categories mapped to the Theoretical Domains Framework. Discussion Adopting this systematic and comprehensive process evaluation approach will help ensure data is captured on all aspects of the trial, enabling a full understanding of the intervention implementation and RCT findings. Trial registration ISRCTN ISRCTN22729870. Registered on 24 August 2022.

Background/Objectives: Vaccinating care home staff is essential to protect vulnerable residents by reducing infection risks and creating a safer care environment. However, vaccine hesitancy amongst staff remains a challenge, particularly since the COVID-19 pandemic raised concerns about side effects and vaccination mandates. This study examines how the pandemic influenced flu vaccine hesitancy amongst UK care home staff. Methods: Data were collected from the FluCare trials conducted over the 2021–22 and 2022–23 winter seasons to explore the impact of concurrent mandatory and non-mandatory COVID-19 vaccination policies on flu vaccine uptake. A total of 52 interviews (21 from the feasibility study and 31 from the randomised control trial) were conducted with care home managers and staff. Thematic analysis identified key themes shaping staff attitudes toward flu vaccination. Results: Four central themes emerged regarding the impact of the pandemic on staff attitudes and the contextual influences shaping vaccine hesitance: (i) tension between autonomy and morals in vaccination decisions; (ii) the COVID ‘craze’ and the displacement of the flu vaccine; (iii) the role of the COVID ‘craze’ in staff vaccine fatigue; and (iv) conspiracies, (mis)information, and the significance of trust. Psychosocial theories on decision making and health behaviour were used to further interpret the findings. Conclusions: Our findings suggest that post-COVID-19 interventions in care home setting should address the issues of autonomy, vaccine fatigue, and trust to enhance vaccine uptake. Understanding these factors could support more effective strategies to address hesitancy amongst care home staff in future vaccination campaigns.

Background The needs of children in care are a government priority, yet the evidence base for effective interventions to support the emotional wellbeing of children in care is lacking. Research suggests that supporting the carer-child relationship, by promoting the carer’s reflective parenting, may be an effective approach to improving the wellbeing of these children. Methods The study comprises a definitive, superiority, two-armed, parallel, pragmatic, randomised controlled trial, with embedded process evaluation and economic evaluation, and an internal pilot, to evaluate the effectiveness, and cost-effectiveness, of the Reflective Fostering Programme. Randomisation is at the individual level using a 1:1 allocation ratio. The study is being conducted in local authority sites across England, and is targeted at foster carers (including kinship carers) looking after children aged 4 to 13. Consenting participants are randomly allocated to the Reflective Fostering Programme (intervention arm) in addition to usual support or usual support alone (control arm). The primary outcome is behavioural and emotional wellbeing of the child 12 months post-baseline, and secondary outcomes include the following: foster carer’s level of stress, quality of life, reflective capacity, compassion fatigue and burnout, placement stability, the quality of the child-carer relationship, child’s capacity for emotional regulation, and achievement of personalised goals set by the carer. Discussion A feasibility study has indicated effectiveness of the Programme in improving the child-carer relationship and emotional and behavioural wellbeing of children in care. This study will test the effectiveness and cost-effectiveness of implementing the Reflective Fostering Programme as an additional aid to the support already available to local authority foster carers. Trial registration ISRCTN 70832140 .

Newborn screening for cystic fibrosis might not be introduced if implementation and running costs are perceived as prohibitive. Compared with clinical diagnosis, newborn screening is associated with clinical benefit and reduced treatment needs. We estimate the potential savings in treatment costs attributable to newborn screening. Using the UK Cystic Fibrosis Database, we used a prevalence strategy to undertake a cost of illness retrospective snapshot cohort study. We estimated yearly costs of long-term therapies and intravenous antibiotics for 184 patients who were diagnosed as a result of screening as newborn babies, and 950 patients who were clinically diagnosed aged 1–9 years in 2002. Costs of adding cystic fibrosis screening to an established newborn screening service in Scotland were adjusted to 2002 prices and applied to the UK as a whole. Costs were recalculated in US$. Cost of therapy for patients diagnosed by newborn screening was significantly lower than equivalent therapies for clinically diagnosed patients: mean ($7228 vs $12 008, 95% CI of difference −6736 to −2028, p<0·0001) and median ($352 vs $2442, −1916 to −180, p<0·0001). When we limited the clinically diagnosed group to only those diagnosable with a 31 cystic fibrosis transmembrane regulator mutation assay and assumed similar disease progression in the clinically diagnosed group as in the newborn screening group, we showed that mean ($3 397 344) or median ($947 032) drug cost savings could have offset the estimated cost of adding cystic fibrosis to a UK national newborn screening service ($2 971 551). Including indirect costs savings, newborn screening for cystic fibrosis might have even greater financial benefits to society than our estimate shows. Clinical, social, and now economic evidence suggests that universal newborn screening programmes for cystic fibrosis should be adopted internationally.

The care home staff influenza vaccination rate in England is significantly lower than the 75% World Health Organisation recommendation. This represents a substantial potential for resident harm. Barriers to staff vaccination stem from individual and organisational levels. Existing interventions address some but not all barriers and are not underpinned by behavioural science theory. This study aims to estimate the effectiveness and cost-effectiveness of a theory-informed intervention to improve care home staff vaccination rates compared to routine practice. Set in care homes with both nursing and residential focus, and a range of ownership status, only homes providing long stay care to older people with a staff vaccination rate below 40% are eligible to participate. Participation expressions of interest will be sought using a variety of approaches prior to seeking consent. The primary outcome measure is the proportion of staff vaccinated at 6 months, with secondary outcome measures being proportion vaccinated at 3 months, numbers of staff sick days, general practitioner and nurse visits to care home, care home resident hospitalisations and mortality. Based on the assumptions that the mean cluster (care home) size is 54 staff, a coefficient of variation of 0.48, control vaccination rate is 55%, intervention 75%, intra-cluster correlation coefficient of 0.2 and with 90% power, and 20% attrition, we require 39 care homes per arm. Blocked randomisation will be at the level of care home, stratified by the proportion of non-white care home staff, and implemented by Norwich Clinical Trials Unit. The intervention comprises co-designed information videos and posters, provision of in-house staff vaccination clinics, and incentive scheme and monthly data collection on trial outcomes. Beyond usual practice, the control arm will additionally contribute monthly data. Data will be collected at the start, monthly and at 6 months, and analysis will be blind to allocation. Statistical analysis will use the intention-to-treat principle with the difference in vaccination rates between groups compared using a random effect logistic regression model at the staff-level. This will be the first study to use a theory-informed intervention designed to comprehensively address identified barriers to care home staff influenza vaccination. Trial registration: ISRCTN ISRCTN22729870 . Registered on 24 August 22. Secondary identifiers: R209939, IRAS 316820, CPMS 53812.