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There is limited evidence on the effectiveness of parenting interventions to improve disruptive behaviour in children with intellectual developmental disabilities. This clinical trial evaluated whether an adapted group parenting intervention for preschool children with intellectual developmental disabilities who display challenging behaviour is superior to treatment as usual in England. 261 children aged 30-59 months with moderate to severe intellectual developmental disabilities and challenging behaviour were randomised to either the intervention (Stepping Stones Triple P) and treatment as usual or treatment as usual alone. The primary outcome was the parent-rated Child Behaviour Checklist at 52 weeks after randomisation. A health economic evaluation was also completed. We found no significant difference between arms on the primary outcome (mean difference -4.23; 95% CI: -9.99 to 1.53; p = 0.147). However, a subgroup analysis suggests the intervention was effective for participants randomised before the COVID-19 pandemic (mean difference -7.12; 95% CI: -13.44 to -0.81; p = 0.046). Furthermore, a complier average causal effects analysis (mean difference -11.53; 95% CI: -26.97 to 3.91; p = 0.143) suggests the intervention requires participants to receive a sufficient intervention dose. The intervention generated statistically significant cost savings (-£1,057.88; 95% CI -£3,218.6 to -£46.67) but the mean point estimate in Quality Adjusted Life Years was similar in both groups. This study did not find an effect of the intervention on reducing challenging behaviour, but this may have been influenced by problems with engagement. The intervention could be considered by services as an early intervention if families are supported to attend, especially given its low cost.

People with dementia living in care homes often experience clinically significant agitation; however, little is known about its economic impact. To calculate the cost of agitation in people with dementia living in care homes. We used the baseline data from 1,424 residents with dementia living in care homes (part of Managing Agitation and Raising QUality of lifE in dementia (MARQUE) study) that had Cohen-Mansfield Agitation Inventory (CMAI) scores recorded. We investigated the relationship between residents' health and social care costs and severity of agitation based on the CMAI total score. In addition, we assessed resource utilisation and compared costs of residents with and without clinically significant symptoms of agitation using the CMAI over and above the cost of the care home. Agitation defined by the CMAI was a significant predictor of costs. On average, a one-point increase in the CMAI will lead to a 0.5 percentage points (cost ratio 1.005, 95%CI 1.001 to 1.010) increase in the annual costs. The excess annual cost associated with agitation per resident with dementia was £1,125.35. This suggests that, on average, agitation accounts for 44% of the annual health and social care costs of dementia in people living in care homes. Agitation in people with dementia living in care homes contributes significantly to the overall costs increasing as the level of agitation increases. Residents with the highest level of agitation cost nearly twice as much as those with the lowest levels of agitation, suggesting that effective strategies to reduce agitation are likely to be cost-effective in this setting.

Background Intraventricular haemorrhage (IVH) is a common and severe complication of preterm birth, affecting nearly 500 neonates annually in the UK. Over 50% of infants with IVH develop post-haemorrhagic ventricular dilatation (PHVD), which is associated with significant long-term neurodevelopmental impairment. Current treatment strategies involve the use of temporary CSF diversion, through options such as ventricular access devices (VADs) or ventricular subgaleal shunts (VSGS). Neuroendoscopic lavage (NEL) is an emerging technique that aims to directly reduce the load of intraventricular blood and its breakdown products, potentially reducing the risk of secondary brain injury. The ENLIVEN-UK trial aims to assess whether the addition of NEL to standard temporising device placement improves neurodevelopmental outcomes at 2 years of corrected age compared to temporising device placement alone. Methods ENLIVEN-UK is a national, multicentre, parallel-group, assessor-blinded, superiority randomised controlled trial (RCT) that aims to enrol 100 preterm infants with severe IVH and PHVD across UK paediatric neurosurgical centres. Infants will be randomised in a 1:1 ratio to receive either standard temporising device placement or NEL in addition to temporising device placement. Randomisation will be performed using a secure online system (Sealed Envelope), with outcome assessors and statisticians blinded to treatment allocation. The primary outcome measure will be cognitive quotient (CQ) at 2 years of corrected age, assessed using the Bayley Scales of Infant and Toddler Development (4th edition, Bayley-IV). Secondary outcomes will include motor and language development, the requirement for permanent CSF diversion with a ventriculoperitoneal (VP) shunt, surgical complications, health-related quality of life (EQ-5D-5L, TAPQOL), and healthcare costs. Discussion This study aims to provide level 1 evidence regarding the efficacy and safety of NEL in preterm infants with IVH and PHVD. If successful, this trial has the potential to change the standard of care and improve long-term neurodevelopmental outcomes in this cohort of patients. Trial registration ISRCTN Trial Registration: ISRCTN14018410.

ObjectivesTo pilot a complex intervention to support healthcare and improve early detection and treatment for common health conditions experienced by nursing home (NH) residents.DesignPilot cluster randomised controlled trial.Setting14 NHs (7 intervention, 7 control) in London and West Yorkshire.ParticipantsNH residents, their family carers and staff.InterventionComplex intervention to support healthcare and improve early detection and treatment of urinary tract and respiratory infections, chronic heart failure and dehydration, comprising: (1) ‘Stop and Watch (S&W)’ early warning tool for changes in physical health, (2) condition-specific care pathway and (3) Situation, Background, Assessment and Recommendation tool to enhance communication with primary care. Implementation was supported by Practice Development Champions, a Practice Development Support Group and regular telephone coaching with external facilitators.Outcome measuresData on NH (quality ratings, size, ownership), residents, family carers and staff demographics during the month prior to intervention and subsequently, numbers of admissions, accident and emergency visits, and unscheduled general practitioner visits monthly for 6 months during intervention. We collected data on how the intervention was used, healthcare resource use and quality of life data for economic evaluation. We assessed recruitment and retention, and whether a full trial was warranted.ResultsWe recruited 14 NHs, 148 staff, 95 family carers and 245 residents. We retained the majority of participants recruited (95%). 15% of residents had an unplanned hospital admission for one of the four study conditions. We were able to collect sufficient questionnaire data (all over 96% complete). No NH implemented intervention tools as planned. Only 16 S&W forms and 8 care pathways were completed. There was no evidence of harm.ConclusionsRecruitment, retention and data collection processes were effective but the intervention not implemented. A full trial is not warranted.Trial registration numberISRCTN74109734 (https://doi.org/10.1186/ISRCTN74109734).Original protocolBMJ Open. 2019;9(5):e026510. doi:10.1136/bmjopen-2018-026510.

IntroductionFlexor tendons are traditionally repaired under either general anaesthesia (GA) or regional anaesthesia (RA), allowing for the use of an arm tourniquet to minimise blood loss and establish a bloodless surgical field. However, the use of tourniquets exposes the patient to certain risks, including skin, muscle and nerve injuries. A recent advancement in anaesthesia delivery involves the use of a wide-awake approach where no sedation nor tourniquets are used (wide-awake local anaesthesia no tourniquet (WALANT)). WALANT uses local anaesthetic with epinephrine to provide pain relief and vasoconstriction, reducing operative bleeding. Several studies revealed potential benefits for WALANT compared with GA or RA. However, there remains a paucity of high-quality evidence to support the use of WALANT. As a result of this uncertainty, the clinical practice varies considerably. We aim to evaluate the feasibility of WALANT as an alternative to GA and RA in patients undergoing surgical repair of flexor tendon injuries. This involves addressing factors such as clinician and patient support for a trial, clinical equipoise, trial recruitment and dropout and the most relevant outcomes measures for a future definitive trial.Methods and analysisWAFER is a multicentre, single-blinded, parallel group, randomised controlled trial (RCT) to assess the feasibility of WALANT versus RA and GA. The target population is patients with acute traumatic flexor tendon injuries, across 3 major hand surgery units in England involving a total of 60 participants. Outcome assessors will be blinded. The primary outcome will be the ability to recruit patients into the trial, while secondary outcomes include difference in functional outcome, patient-reported outcome measures, health-related quality of life, cost-effectiveness and complication rates.Ethics and disseminationEthical approval was obtained from the London—City and East Research Ethics Committee (22/PR/1197). Findings will be disseminated through peer-reviewed publication, conferences, patient information websites and social media networks.Trial registration numberISRCTN identifier: 15052559.

ObjectivesNosocomial transmission of SARS-CoV-2 has been a significant cause of mortality in National Health Service (NHS) hospitals during the COVID-19 pandemic. The COG-UK Consortium Hospital-Onset COVID-19 Infections (COG-UK HOCI) study aims to evaluate whether the use of rapid whole-genome sequencing of SARS-CoV-2, supported by a novel probabilistic reporting methodology, can inform infection prevention and control (IPC) practice within NHS hospital settings.DesignMulticentre, prospective, interventional, superiority study.Setting14 participating NHS hospitals over winter–spring 2020/2021 in the UK.ParticipantsEligible patients must be admitted to hospital with first-confirmed SARS-CoV-2 PCR-positive test result >48 hour from time of admission, where COVID-19 diagnosis not suspected on admission. The projected sample size is 2380 patients.InterventionThe intervention is the return of a sequence report, within 48 hours in one phase (rapid local lab processing) and within 5–10 days in a second phase (mimicking central lab), comparing the viral genome from an eligible study participant with others within and outside the hospital site.Primary and secondary outcome measuresThe primary outcomes are incidence of Public Health England (PHE)/IPC-defined SARS-CoV-2 hospital-acquired infection during the baseline and two interventional phases, and proportion of hospital-onset cases with genomic evidence of transmission linkage following implementation of the intervention where such linkage was not suspected by initial IPC investigation. Secondary outcomes include incidence of hospital outbreaks, with and without sequencing data; actual and desirable changes to IPC actions; periods of healthcare worker (HCW) absence. Health economic analysis will be conducted to determine cost benefit of the intervention. A process evaluation using qualitative interviews with HCWs will be conducted alongside the study.Trial registration numberISRCTN50212645. Pre-results stage. This manuscript is based on protocol V.6.0. 2 September 2021.

Childhood overweight and obesity have health and economic impacts on individuals and the wider society. Families participating in weight management programmes may foresee or experience monetary and other costs which deter them from signing up to or completing programmes. This is recognised in the health economics literature, though within this sparse body of work, costs to families are often narrowly defined and not fully accounted for. A societal perspective incorporating a broader array of costs may provide a more accurate picture. This paper brings together a review of the health economics literature on the costs to families attending child weight management programmes with qualitative data from families participating in a programme to manage child overweight and obesity. A search identified economic evaluation studies of lifestyle interventions in childhood obesity. The qualitative work drew on interviews with families who attended a weight management intervention in three UK regions. We identified four cost-effectiveness analyses that include information on costs to families. These were categorised as direct (e.g. monetary) and indirect (e.g. time) costs. Our analysis of qualitative data demonstrated that, for families who attended the programme, costs were associated both with participation on the scheme and with maintaining a healthy lifestyle afterwards. Respondents reported three kinds of cost: time-related, social/emotional and monetary. Societal approaches to measuring cost-effectiveness provide a framework for assessing the monetary and non-monetary costs borne by participants attending treatment programmes. From this perspective, all costs should be considered in any analysis of cost-effectiveness. Our data suggest that family costs are important, and may act as a barrier to the uptake, completion and maintenance of behaviours to reduce child obesity. These findings have implications for the development and implementation of child weight initiatives in particular, in relation to reducing inequalities in health.

Background Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities. Methods This trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30–59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual, whilst the Treatment as Usual only group receive other available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data will also be collected to carry out a cost effectiveness and utility evaluation. Discussion Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities. Trial registration number Clinicaltrials.gov , NCT03086876. Registered 22nd March 2017, https://clinicaltrials.gov/ct2/show/NCT03086876 .

Depression is common in people with dementia, and negatively affects quality of life. This paper aims to evaluate the cost-effectiveness of an intervention for depression in mild and moderate dementia caused by Alzheimer's disease over 12 months (PATHFINDER trial), from both the health and social care and societal perspectives. A total of 336 participants were randomised to receive the adapted PATH intervention in addition to treatment as usual (TAU) ( = 168) or TAU alone ( = 168). Health and social care resource use were collected with the Client Service Receipt Inventory and health-related quality-of-life data with the EQ-5D-5L instrument at baseline and 3-, 6- and 12-month follow-up points. Principal analysis comprised quality-adjusted life-years (QALYs) calculated from the participant responses to the EQ-5D-5L instrument. The mean cost of the adapted PATH intervention was estimated at £1141 per PATHFINDER participant. From a health and social care perspective, the mean difference in costs between the adapted PATH and control arm at 12 months was -£74 (95% CI -£1942 to £1793), and from the societal perspective was -£671 (95% CI -£9144 to £7801). The mean difference in QALYs was 0.027 (95% CI -0.004 to 0.059). At £20 000 per QALY gained threshold, there were 74 and 68% probabilities of adapted PATH being cost-effective from the health and social care and societal perspective, respectively. The addition of the adapted PATH intervention to TAU for people with dementia and depression generated cost savings alongside a higher quality of life compared with TAU alone; however, the improvements in costs and QALYs were not statistically significant.

Doxorubicin/ifosfamide is a first-line systemic chemotherapy for the majority of advanced soft tissue sarcoma (ASTS) subtypes. Trabectedin is indicated for the treatment of ASTS after failure of anthracyclines and/or ifosfamide; however it is being increasingly used off-label as a first-line treatment. This study estimated the cost effectiveness of these two treatments in the first-line management of ASTS in Italy, Spain, and Sweden. Methods. A Markov model was constructed to estimate the cost effectiveness of doxorubicin/ifosfamide compared to trabectedin monotherapy, defined as the cost per QALY gained, in each country. Results. First-line treatment with doxorubicin/ifosfamide resulted in lower two-year healthcare costs and more QALYs than first-line treatment with trabectedin monotherapy in all three countries. Probabilistic sensitivity analysis showed that at a cost per QALY threshold of €35,000, >90% of a cohort would be cost effectively treated with doxorubicin/ifosfamide compared to trabectedin monotherapy in all three countries. Conclusion. Within the model’s limitations, first-line treatment of patients with ASTS with doxorubicin/ifosfamide instead of trabectedin monotherapy affords a cost-effective use of publicly funded healthcare resources in Italy, Spain, and Sweden and is therefore the preferred treatment in all three countries. These findings support the recommendation that trabectedin should remain a second-line treatment.