A feasibility study of signed consent for the collection of patient identifiable information for a national paediatric clinical audit database

Objectives: To investigate the feasibility of obtaining signed consent for submission of patient identifiable data to a national clinical audit database and to identify factors influencing the consent process and its success. Design: Feasibility study. Setting: Seven paediatric intensive care units in England. Participants: Parents/guardians of patients, or patients aged 12-16 years old, approached consecutively over three months for signed consent for submission of patient identifiable data to the national clinical audit database the Paediatric Intensive Care Audit Network (PICANet). Main outcome measures: The numbers and proportions of admissions for which signed consent was given, refused, or not obtained (form not returned or form partially completed but not signed), by age, sex, level of deprivation, ethnicity (South Asian or not), paediatric index of mortality score, length of hospital stay (days in paediatric intensive care). Results: One unit did not start and one did not fully implement the protocol, so analysis excluded these two units. Consent was obtained for 182 of 422 admissions (43%) (range by unit 9% to 84%). Most (101/182; 55%) consents were taken by staff nurses. One refusal (0.2%) was received. Consent rates were significantly better for children who were more severely ill on admission and for hospital stays of six days or more, and significantly poorer for children aged 10-14 years. Long hospital stays and children aged 10-14 years remained significant in a stepwise regression model of the factors that were significant in the univariate model. Conclusion: Systematically obtaining individual signed consent for sharing patient identifiable information with an externally located clinical audit database is difficult. Obtaining such consent is unlikely to be successful unless additional resources are specifically allocated to training, staff time, and administrative support

How, in what contexts, and why do quality dashboards lead to improvements in care quality in acute hospitals? Protocol for a realist feasibility evaluation

Introduction: National audits are used to monitor care quality and safety and are anticipated to reduce unexplained variations in quality by stimulating quality improvement (QI). However, variation within and between providers in the extent of engagement with national audits means that the potential for national audit data to inform QI is not being realised. This study will undertake a feasibility evaluation of QualDash, a quality dashboard designed to support clinical teams and managers to explore data from two national audits, the Myocardial Ischaemia National Audit Project (MINAP) and the Paediatric Intensive Care Audit Network (PICANet). Methods and analysis: Realist evaluation, which involves building, testing and refining theories of how an intervention works, provides an overall framework for this feasibility study. Realist hypotheses that describe how, in what contexts, and why QualDash is expected to provide benefit will be tested across five hospitals. A controlled interrupted time series analysis, using key MINAP and PICANet measures, will provide preliminary evidence of the impact of QualDash, while ethnographic observations and interviews over 12 months will provide initial insight into contexts and mechanisms that lead to those impacts. Feasibility outcomes include the extent to which MINAP and PICANet data are used, data completeness in the audits, and the extent to which participants perceive QualDash to be useful and express the intention to continue using it after the study period. Ethics and dissemination: The study has been approved by the University of Leeds School of Healthcare Research Ethics Committee. Study results will provide an initial understanding of how, in what contexts, and why quality dashboards lead to improvements in care quality. These will be disseminated to academic audiences, study participants, hospital IT departments and national audits. If the results show a trial is feasible, we will disseminate the QualDash software through a stepped wedge cluster randomised trial

Preserved differentiation between physical activity and cognitive performance across young, middle, and older adulthood over 8 years.

Objectives: A critical question in the activity engagement literature is whether physical exercise alters the trajectory of age-related cognitive decline (differential preservation) or is associated with enhanced baseline cognitive ability (preserved differentiation). Further, investigations considering that these relations may differ across young, middle, and older adulthood are rare. Method: We evaluated data from the PATH Through Life Project, where participants aged 20-24, 40-44, and 60-64 years at baseline (n = 6,869) completed physical activity (PA; mild, moderate, and vigorous) and cognitive measurements thrice over 8 years. Results: Multilevel models accounting for employment status, sex, education, health, and mental and social activity showed that between-person differences in PA participation positively predicted baseline performance on fluid cognitive ability (perceptual speed, short-term memory, working memory, and episodic memory). These effects were similar across age groups, but strongest for the youngest cohort, for whom there was also evidence of covariation between within-person change in PA and cognitive score. PA was not associated with change in cognition over time. DISCUSSION: Results support preserved differentiation, where physically active adults have higher initial cognitive ability, and the advantage is maintained over time. PA appears to be unique in showing differences across young, middle, and older adulthood in predicting cognition

Routine gastric residual volume measurement to guide enteral feeding in mechanically ventilated infants and children : the GASTRIC feasibility study

Background The routine measurement of gastric residual volume to guide the initiation and delivery of enteral feeding, is widespread in paediatric intensive care and neonatal units, but has little underlying evidence to support it. Objective(s) To answer the question: Is it feasible to conduct a trial of not measuring gastric residual volume on clinical outcomes in mechanically ventilated infants and children in the UK? Design A mixed methods study involving five linked work packages in two parallel arms, neonatal units and paediatric intensive care units. 1. A survey of units to establish current UK practice. 2. qualitative interviews with healthcare professionals and caregivers of children admitted to either setting. 3. A modified two-round e-Delphi survey to investigate health care professionals’ opinions on trial design issues and to obtain consensus on outcomes. 4. National databases were examined to determine the potential eligible populations. 5. Two consensus meetings, of health care professionals and parents to review the data and agreed consensus on outcomes that had not reached consensus in the e-Delphi. Participants and setting Parents of children with experience of ventilation and tube feeding in both neonatal units and in paediatric intensive care units, and health care professionals working in neonatal units and paediatric intensive care units. Results Baseline surveys showed the practice of gastric residual volume measurement was very common: 96% PICUs and 65% in neonatal units. Ninety percent of parents both from neonatal units and paediatric intensive care units supported a future trial, whilst highlighting concerns around possible delays in detecting complications. Health care professionals also indicated a trial was feasible, with 84% of staff willing to participate in a trial. Concerns expressed by junior nurses about the intervention arm of not measuring gastric residual volumes were addressed by developing a simple flowchart and education package. The trial design survey and e-Delphi study gained consensus on trial 12 PICU and 9 neonatal unit outcome measures and identified acceptable inclusion and exclusion criteria. Given the differences in physiology, disease processes, environments, staffing and outcomes of interest, two different trials are required in the two settings. Database analyses subsequently showed trials were feasible in both settings in terms of patient numbers. Of 16222 children who met the inclusion criteria in PICU 12 629 stayed > 3 days. In neonatal units, 15 375 neonates <32 weeks age. Finally, the two consensus meetings demonstrated ‘buy in’ from the wider UK neonatal communities and paediatric intensive care units and enabled us to discuss and vote on the outcomes that did not achieve consensus in the e-Delphi study. Conclusions and future work Two separate UK trials (one in neonatal units and one in paediatric intensive care units) are feasible to conduct, but they cannot be combined due to differences in outcome measures and treatment protocols, reflecting the distinctness of the two specialties

Observation of B+ to Lambda Lambdabar K+

We report the first observation of the charmless hyperonic B decay, B^+ --> Lambda Lambdabar K^+, using a 140 fb^-1 data sample recorded at the Upsilon(4S) resonance with the Belle detector at the KEKB e^+e^- collider. The measured branching fraction is B(B^+ --> Lambda Lambdabar K^+) = 2.91 ^{+0.90}_{-0.70} +/- 0.38 *10^-6 . We also perform a search for the related decay mode B^+ --> Lambda Lambdabar pi^+, but do not find a significant signal. We set a 90% confidence-level upper limit of B(B^+ --> Lambda Lambdabar pi^+) < 2.8 * 10^-6.Comment: 9 pages, 3 figures, submitted to Phys. Rev. Let

Co-ordinated multidisciplinary intervention to reduce time to successful extubation for children on mechanical ventilation: the SANDWICH cluster stepped-wedge RCT

BACKGROUND: Daily assessment of patient readiness for liberation from invasive mechanical ventilation can reduce the duration of ventilation. However, there is uncertainty about the effectiveness of this in a paediatric population. OBJECTIVES: To determine the effect of a ventilation liberation intervention in critically ill children who are anticipated to have a prolonged duration of mechanical ventilation (primary objective) and in all children (secondary objective). DESIGN: A pragmatic, stepped-wedge, cluster randomised trial with economic and process evaluations. SETTING: Paediatric intensive care units in the UK. PARTICIPANTS: Invasively mechanically ventilated children (aged < 16 years). INTERVENTIONS: The intervention incorporated co-ordinated multidisciplinary care, patient-relevant sedation plans linked to sedation assessment, assessment of ventilation parameters with a higher than usual trigger for undertaking an extubation readiness test and a spontaneous breathing trial on low levels of respiratory support to test extubation readiness. The comparator was usual care. Hospital sites were randomised sequentially to transition from control to intervention and were non-blinded. MAIN OUTCOME MEASURES: The primary outcome measure was the duration of invasive mechanical ventilation until the first successful extubation. The secondary outcome measures were successful extubation, unplanned extubation and reintubation, post-extubation use of non-invasive ventilation, tracheostomy, post-extubation stridor, adverse events, length of intensive care and hospital stay, mortality and cost per respiratory complication avoided at 28 days. RESULTS: The trial included 10,495 patient admissions from 18 paediatric intensive care units from 5 February 2018 to 14 October 2019. In children with anticipated prolonged ventilation (n = 8843 admissions: control, n = 4155; intervention, n = 4688), the intervention resulted in a significantly shorter time to successful extubation [cluster and time-adjusted median difference -6.1 hours (interquartile range -8.2 to -5.3 hours); adjusted hazard ratio 1.11, 95% confidence interval 1.02 to 1.20; p = 0.02] and a higher incidence of successful extubation (adjusted relative risk 1.01, 95% confidence interval 1.00 to 1.02; p = 0.03) and unplanned extubation (adjusted relative risk 1.62, 95% confidence interval 1.05 to 2.51; p = 0.03), but not reintubation (adjusted relative risk 1.10, 95% confidence interval 0.89 to 1.36; p = 0.38). In the intervention period, the use of post-extubation non-invasive ventilation was significantly higher (adjusted relative risk 1.22, 95% confidence interval 1.01 to 1.49; p = 0.04), with no evidence of a difference in intensive care length of stay or other harms, but hospital length of stay was longer (adjusted hazard ratio 0.89, 95% confidence interval 0.81 to 0.97; p = 0.01). Findings for all children were broadly similar. The control period was associated with lower, but not statistically significantly lower, total costs (cost difference, mean £929.05, 95% confidence interval -£516.54 to £2374.64) and significantly fewer respiratory complications avoided (mean difference -0.10, 95% confidence interval -0.16 to -0.03). LIMITATIONS: The unblinded intervention assignment may have resulted in performance or detection bias. It was not possible to determine which components were primarily responsible for the observed effect. Treatment effect in a more homogeneous group remains to be determined. CONCLUSIONS: The intervention resulted in a statistically significant small reduction in time to first successful extubation; thus, the clinical importance of the effect size is uncertain. FUTURE WORK: Future work should explore intervention sustainability and effects of the intervention in other paediatric populations

Improved Measurements of Partial Rate Asymmetry in B -> h h Decays

We report improved measurements of the partial rate asymmetry (Acp) in B -> h h decays with 140fb^-1 of data collected with the Belle detector at the KEKB e+e- collider. Here h stands for a charged or neutral pion or kaon and in total five decay modes are included: K-+ pi+-, K0s pi-+, K-+ pi0, pi-+ pi0 and K0s pi0. The flavor of the last decay mode is determined from the accompanying B meson. Using a data sample 4.7 times larger than that of our previous measurement, we find Acp(K-+ pi+-) -0.088+-0.035+-0.013, 2.4 sigma from zero. Results for other decay modes are also presented.Comment: 9 pages, 1 figur

Does owning a pet protect older people against loneliness?

This article has been made available through the Brunel Open Access Publishing Fund.Pet ownership is thought to make a positive contribution to health, health behaviours and the general well-being of older people. More specifically pet ownership is often proposed as a solution to the problem of loneliness in later life and specific 'pet based' interventions have been developed to combat loneliness. However the evidence to support this relationship is slim and it is assumed that pet ownership is a protection against loneliness rather than a response to loneliness. The aim of this paper is to examine the association between pet ownership and loneliness by exploring if pet ownership is a response to, or protection against, loneliness using Waves 0-5 from the English Longitudinal Study of Ageing (ELSA)