Bristol girls dance project feasibility study: Using a pilot economic evaluation to inform design of a full trial

Background: There is currently little guidance for pilot trial economic evaluation where health outcomes and costs are influenced by a range of wider determinants and factors. Objectives: This article presents the findings of a pilot economic evaluation study running alongside the Bristol Girls Dance Project (BGDP) feasibility study. Design: 3-arm, cluster randomised, controlled pilot trial and economic evaluation. 7 schools (n=210) from the Bristol and greater Bristol area, UK were randomly allocated to the intervention arm 3 schools (n=90) and the control arm 4 schools (n=120). Intervention: Girls aged 11-12 years with parental consent were provided with two, 90 min dance sessions per week for 9 weeks at school facilities. Economic outcome measures: Programme costs and girls' preferences for attributes of dance and preferences for competing leisure time activities were measured. Results: The mainstream average cost of the BGDP programme (not including research, control and dance teacher training costs) per school was $2126.40, £1329 and €1555 and per participant was$70.90, £44.31 and €51.84 in 2010-2011 prices. Discrete choice experiment (DCE) methods are acceptable to girls of this age indicating time available for other leisure activities on dance class days is the attribute girls valued most and 2 h leisure time remaining preferred to 3 h. Conclusions: This pilot study indicates that providing full cost data for a future trial of the BGDP programme is feasible and practical. There is no evidence from preference data to support adjustment to intervention design. A future economic evaluation is likely to be successful utilising the resource use checklist developed. The importance of categorising separately resources used to develop, prepare, deliver and maintain the programme to estimate mainstream costs accurately is demonstrated

Turning the gaze:Digital patient feedback and the silent pathology of the NHS

Online review and rating sites, where patients can leave feedback on their experience of the health-care encounter, are becoming an increasing feature of primary care in the NHS. Previous research has analysed how digital surveillance is re-shaping the clinical gaze, as health-care professionals are subject to increased public monitoring. Here, we draw on an empirical study of 41 GP practice staff to show how the gaze is turning, not simply from the patient to the health-care provider, but additionally to the body politic of the NHS. Drawing on focus group and interview data conducted in five UK practices, we show how discourses of online reviews and ratings are producing new professional subjectivities among health-care professionals and the extent to which the gaze extends not only to individual health-care interactions but to the health-care service writ large. We identify three counter-discourses characterising the evolving ways in which online reviews and ratings are creating new subjects in primary care practices: victimhood, prosumption versus traditional values and taking control. We show how the ways in which staff speak about online feedback are patterned by the social environment in which they work and the constraints of the NHS they encounter on a day-to-day basis

Ligand-Doped Copper Oxo-hydroxide Nanoparticles are Effective Antimicrobials.

Bacterial resistance to antimicrobial therapies is an increasing clinical problem. This is as true for topical applications as it is for systemic therapy. Topically, copper ions may be effective and cheap antimicrobials that act through multiple pathways thereby limiting opportunities to bacteria for resistance. However, the chemistry of copper does not lend itself to facile formulations that will readily release copper ions at biologically compatible pHs. Here we have developed nanoparticulate copper hydroxide adipate tartrate (CHAT) as a cheap, safe and readily synthesised material that should enable antimicrobial copper ion release in an infected wound environment. First, we synthesised CHAT and showed that this had disperse aquated particle sizes of 2-5 nm, and mean zeta potential of -40 mV. Next, when diluted into bacterial medium, CHAT demonstrated similar efficacy to copper chloride against Escherichia coli and Staphylococcus aureus, with dose-dependent activity occurring mostly around 12.5-50 mg/L of copper. Indeed, at these levels, CHAT very rapidly dissolved and, as confirmed by a bacterial copper biosensor, showed identical intracellular loading to copper ions derived from copper chloride. However, when formulated at 250 mg/L in a topically-applied matrix, namely hydroxyethyl cellulose, the benefit of CHAT over copper chloride was apparent. The former yielded rapid sustained release of copper within the bactericidal range but the copper chloride, which formed insoluble precipitates at such concentration and pH, achieved a maximum release of 10 ± 7 mg/L copper by 24 hours. We provide a practical formulation for topical copper - based antimicrobial therapy. Further studies, especially in vivo, are merited

Safety and Improvement of Movement Function After Stroke with Atomoxetine: A Pilot Randomized Trial

Background: Intensive, task-oriented motor training has been associated with neuroplastic reorganization and improved upper extremity movement function after stroke. However, to optimize such training for people with moderate-to-severe movement impairment, pharmacological modulation of neuroplasticity may be needed as an adjuvant intervention. Objective: Evaluate safety, as well as improvement in movement function, associated with motor training paired with a drug to upregulate neuroplasticity after stroke. Methods: In this double-blind, randomized, placebo-controlled study, 12 subjects with chronic stroke received either atomoxetine or placebo paired with motor training. Safety was assessed using vital signs. Upper extremity movement function was assessed using Fugl-Meyer Assessment, Wolf Motor Function Test, and Action Research Arm Test at baseline, post-intervention, and 1-month follow-up. Results: No significant between-groups differences were found in mean heart rate (95% CI, –12.4–22.6; p = 0.23), mean systolic blood pressure (95% CI, –1.7–29.6; p = 0.21), or mean diastolic blood pressure (95% CI, –10.4–13.3; p = 0.08). A statistically significant between-groups difference on Fugl-Meyer at post-intervention favored the atomoxetine group (95% CI, 1.6–12.7; p = 0.016). Conclusion: Atomoxetine combined with motor training appears safe and may optimize motor training outcomes after stroke

Safety and Improvement of Movement Function After Stroke with Atomoxetine: A Pilot Randomized Trial

BACKGROUND: Intensive, task-oriented motor training has been associated with neuroplastic reorganization and improved upper extremity movement function after stroke. However, to optimize such training for people with moderate-to-severe movement impairment, pharmacological modulation of neuroplasticity may be needed as an adjuvant intervention. OBJECTIVE: Evaluate safety, as well as improvement in movement function, associated with motor training paired with a drug to upregulate neuroplasticity after stroke. METHODS: In this double-blind, randomized, placebo-controlled study, 12 subjects with chronic stroke received either atomoxetine or placebo paired with motor training. Safety was assessed using vital signs. Upper extremity movement function was assessed using Fugl-Meyer Assessment, Wolf Motor Function Test, and Action Research Arm Test at baseline, post-intervention, and 1-month follow-up. RESULTS: No significant between-groups differences were found in mean heart rate (95% CI, -12.4-22.6; p = 0.23), mean systolic blood pressure (95% CI, -1.7-29.6; p = 0.21), or mean diastolic blood pressure (95% CI, -10.4-13.3; p = 0.08). A statistically significant between-groups difference on Fugl-Meyer at post-intervention favored the atomoxetine group (95% CI, 1.6-12.7; p = 0.016). CONCLUSION: Atomoxetine combined with motor training appears safe and may optimize motor training outcomes after stroke

Fragile X Newborn Screening: Lessons Learned From a Multisite Screening Study

BACKGROUND: Delays in the diagnosis of children with fragile X syndrome (FXS) suggest the possibility of newborn screening as a way to identify children earlier. However, FXS does not have a proven treatment that must be provided early, and ethical concerns have been raised about the detection of infants who are carriers. This article summarizes major findings from a multisite, prospective, longitudinal pilot screening study. METHODS: Investigators in North Carolina, California, and Illinois collaborated on a study in which voluntary screening for FXS was offered to parents in 3 birthing hospitals. FXS newborn screening was offered to >28 000 families to assess public acceptance and determine whether identification of babies resulted in any measurable harms or adverse events. Secondary goals were to determine the prevalence of FMR1 carrier gene expansions, study the consent process, and describe early development and behavior of identified children. RESULTS: A number of publications have resulted from the project. This article summarizes 10 "lessons learned" about the consent process, reasons for accepting and declining screening, development and evaluation of a decision aid, prevalence of carriers, father participation in consent, family follow-up, and maternal reactions to screening. CONCLUSIONS: The project documented public acceptance of screening as well as the challenges inherent in obtaining consent in the hospital shortly after birth. Collectively, the study provides answers to a number of questions that now set the stage for a next generation of research to determine the benefits of earlier identification for children and families

Bristol Girls Dance Project Feasibility Trial: Outcome and process evaluation results

Background: Many adolescent girls do not engage in sufficient physical activity (PA). This study examined the feasibility of conducting a cluster randomized controlled trial (RCT) to evaluate an after-school dance program to increase PA among 11-12 year old girls in Bristol, UK.Methods: Three-arm, cluster RCT. Three secondary schools were assigned to intervention arm. Intervention participants received a 9-week dance program with 2, 90-minute dance classes per week. Participants at 2 control schools received incentives for data collection. Participants at 2 additional control schools received incentives and a delayed dance workshop. Accelerometer data were collected at baseline (time 0), during the last week of the dance program (time 1) and 20 weeks after the start of the study (time 2). Weekly attendance, enjoyment and perceived exertion were assessed in intervention participants. Post-study qualitative work was conducted with intervention participants and personnel.Results: 40.1% of girls provided consent to be in the study. The mean number of girls attending at least one dance session per week ranged from 15.4 to 25.9. There was greater number of participants for whom accelerometer data were collected in control arms. The mean attendance was 13.3 sessions (maximum = 18). Perceived exertion ratings indicated that the girls did not find the sessions challenging. The dance teachers reported that the program content would benefit from revisions including less creative task time, a broader range of dance genres and improved behavioral management policies. At time 2, the 95% confidence intervals suggest between 5 and 12 minutes more weekday MVPA in the intervention group compared with the control incentives only group, and between 6 minutes fewer and 1 minute more compared with the control incentives plus workshop group. Between 14 and 24 schools would be required to detect a difference of 10 minutes in mean weekday MVPA between intervention and control groups.Conclusions: It is possible to recruit 11-12 year old girls to participate in an after-school dance study. An after-school dance intervention has potential to positively affect the PA levels of 11-12 year old girls but an adequately powered RCT is required to test this intervention approach. © 2012 Jago et al.; licensee BioMed Central Ltd

Incidence, risk factors and the healthcare cost of falls postdischarge after elective total hip and total knee replacement surgery: Protocol for a prospective observational cohort study

Introduction: The number of major joint replacement procedures continues to increase in Australia. The primary aim of this study is to determine the incidence of falls in the first 12 months after discharge from hospital in a cohort of older patients who undergo elective total hip or total knee replacement. Method and analyses: A prospective longitudinal observational cohort study starting in July 2015, enrolling patients aged ≥ 60 years who are admitted for elective major joint replacement (n = 267 total hip replacement, n = 267 total knee replacement) and are to be discharged to the community. Participants are followed up for 12 months after hospital discharge. The primary outcome measure is the rate of falls per thousand patient-days. Falls data will be collected by 2 methods: issuing a falls diary to each participant and telephoning participants monthly after discharge. Secondary outcomes include the rate of injurious falls and health-related quality of life. Patient-rated outcomes will be measured using the Oxford Hip or Oxford Knee score. Generalised linear mixed modelling will be used to examine the falls outcomes in the 12 months after discharge and to examine patient and clinical characteristics predictive of falls. An economic evaluation will be conducted to describe the nature of healthcare costs in the first 12 months after elective joint replacement and estimate costs directly attributable to fall events. Ethics and dissemination: The results will be disseminated through local site networks and will inform future services to support older people undergoing hip or knee joint replacement and also through peer-reviewed publications and medical conferences. This study has been approved by The University of Notre Dame Australia and local hospital human research ethics committees. Trial registration number: ACTRN12615000653561; Pre-results

Psychological preparation and postoperative outcomes for adults undergoing surgery under general anaesthesia

Acknowledgements We wish to dedicate this work to the memory of Christian Osmer, a dedicated, caring doctor who was committed to achieving the best care for his patients and their relatives. He saw his contribution to this project as a way of advancing best care for surgical patients. We are very grateful for his valuable input to this work and the pleasure we had in working with him. We are grateful to Karen Hovhanisyan (former Trials Search Co-ordinator, Cochrane Anaesthesia, Critical and Emergency Care Group (ACE)) for carrying out the electronic database searches and to Jane Cracknell (Managing Editor, ACE) for her support throughout the review process. We would also like to thank W Alastair Chambers and Manjeet Shehmar for clinical advice relating to judgements about general anaesthesia usage, and Yvonne Cooper and Louise Pike who retrieved documents and screened papers as research assistants in earlier stages of the review. We are grateful to the following colleagues who helped us with foreign language papers - either by screening papers or by providing translation: Stefano Carrubba, Chuan Gao, Chen Ji, Kate Rhie, Reza Roudsari and Alena Vasianovich. We would like to thank Andy Smith (content editor), Nathan Pace (statistical editor), Michael Donnelly, Allan Cyna and Michael Wang (peer reviewers), and Shunjie Chua (consumer referee) for their help and editorial advice during the preparation of this systematic review. We would also like to thank Andrew Smith (content editor), Nathan Pace (statistical editor), Michael Wang and Allan Cyna (peer reviewers), and Lynda Lane (Cochrane Consumer Network representative) for their help and editorial advice during the preparation of the protocol (Powell 2010). Sources of support Internal sources Manchester Centre for Health Psychology, University of Manchester, UK. An award of £2000 was received to support research assistant costs. External sources British Academy, UK. We received a small research grant of £7480 to support research assistant costs.Peer reviewedPublisher PD