Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes.

INTRODUCTION: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs). METHODS AND ANALYSIS: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation. ETHICS AND DISSEMINATION: Ethics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals. TRIAL REGISTRATION NUMBER: ISRCTN42908016.

Valuing breastfeeding: a qualitative study of women's experiences of a financial incentive scheme for breastfeeding.

BACKGROUND: A cluster randomised controlled trial of a financial incentive for breastfeeding conducted in areas with low breastfeeding rates in the UK reported a statistically significant increase in breastfeeding at 6-8 weeks. In this paper we report an analysis of interviews with women eligible for the scheme, exploring their experiences and perceptions of the scheme and its impact on breastfeeding to support the interpretation of the results of the trial. METHODS: Semi-structured interviews were carried out with 35 women eligible for the scheme during the feasibility and trial stages. All interviews were recorded and verbatim transcripts analysed using a Framework Analysis approach. RESULTS: Women reported that their decisions about infant feeding were influenced by the behaviours and beliefs of their family and friends, socio-cultural norms and by health and practical considerations. They were generally positive about the scheme, and felt valued for the effort involved in breastfeeding. The vouchers were frequently described as a reward, a bonus and something to look forward to, and helping women keep going with their breastfeeding. They were often perceived as compensation for the difficulties women encountered during breastfeeding. The scheme was not thought to make a difference to mothers who were strongly against breastfeeding. However, women did believe the scheme would help normalise breastfeeding, influence those who were undecided and help women to keep going with breastfeeding and reach key milestones e.g. 6 weeks or 3 months. CONCLUSIONS: The scheme was acceptable to women, who perceived it as rewarding and valuing them for breastfeeding. Women reported that the scheme could raise awareness of breastfeeding and encourage its normalisation. This provides a possible mechanism of action to explain the results of the trial. TRIAL REGISTRATION: The trial is registered with the ISRCTN registry, number 44898617 , https://www.isrctn.com.

Effect of Financial Incentives on Breastfeeding: A Cluster Randomized Clinical Trial.

Importance: Although breastfeeding has a positive effect on an infant's health and development, the prevalence is low in many communities. The effect of financial incentives to improve breastfeeding prevalence is unknown. Objective: To assess the effect of an area-level financial incentive for breastfeeding on breastfeeding prevalence at 6 to 8 weeks post partum. Design, Setting, and Participants: The Nourishing Start for Health (NOSH) trial, a cluster randomized trial with 6 to 8 weeks follow-up, was conducted between April 1, 2015, and March 31, 2016, in 92 electoral ward areas in England with baseline breastfeeding prevalence at 6 to 8 weeks post partum less than 40%. A total of 10 010 mother-infant dyads resident in the 92 study electoral ward areas where the infant's estimated or actual birth date fell between February 18, 2015, and February 17, 2016, were included. Areas were randomized to the incentive plus usual care (n = 46) (5398 mother-infant dyads) or to usual care alone (n = 46) (4612 mother-infant dyads). Interventions: Usual care was delivered by clinicians (mainly midwives, health visitors) in a variety of maternity, neonatal, and infant feeding services, all of which were implementing the UNICEF UK Baby Friendly Initiative standards. Shopping vouchers worth £40 (US$50) were offered to mothers 5 times based on infant age (2 days, 10 days, 6-8 weeks, 3 months, 6 months), conditional on the infant receiving any breast milk. Main Outcomes and Measures: The primary outcome was electoral ward area-level 6- to 8-week breastfeeding period prevalence, as assessed by clinicians at the routine 6- to 8-week postnatal check visit. Secondary outcomes were area-level period prevalence for breastfeeding initiation and for exclusive breastfeeding at 6 to 8 weeks. Results: In the intervention (5398 mother-infant dyads) and control (4612 mother-infant dyads) group, the median (interquartile range) percentage of women aged 16 to 44 years was 36.2% (3.0%) and 37.4% (3.6%) years, respectively. After adjusting for baseline breastfeeding prevalence and local government area and weighting to reflect unequal cluster-level breastfeeding prevalence variances, a difference in mean 6- to 8-week breastfeeding prevalence of 5.7 percentage points (37.9% vs 31.7%; 95% CI for adjusted difference, 2.7% to 8.6%; P < .001) in favor of the intervention vs usual care was observed. No significant differences were observed for the mean prevalence of breastfeeding initiation (61.9% vs 57.5%; adjusted mean difference, 2.9 percentage points; 95%, CI, -0.4 to 6.2; P = .08) or the mean prevalence of exclusive breastfeeding at 6 to 8 weeks (27.0% vs 24.1%; adjusted mean difference, 2.3 percentage points; 95% CI, -0.2 to 4.8; P = .07). Conclusions and Relevance: Financial incentives may improve breastfeeding rates in areas with low baseline prevalence. Offering a financial incentive to women in areas of England with breastfeeding rates below 40% compared with usual care resulted in a modest but statistically significant increase in breastfeeding prevalence at 6 to 8 weeks. This was measured using routinely collected data. Trial Registration: International Standard Randomized Controlled Trial Registry: ISRCTN44898617.

Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation.

BACKGROUND: Duchenne muscular dystrophy (DMD) is a rare disease that causes the progressive loss of motor abilities such as walking. Standard treatment includes physiotherapy. No trial has evaluated whether or not adding aquatic therapy (AT) to land-based therapy (LBT) exercises helps to keep muscles strong and children independent. OBJECTIVES: To assess the feasibility of recruiting boys with DMD to a randomised trial evaluating AT (primary objective) and to collect data from them; to assess how, and how well, the intervention and trial procedures work. DESIGN: Parallel-group, single-blind, randomised pilot trial with nested qualitative research. SETTING: Six paediatric neuromuscular units. PARTICIPANTS: Children with DMD aged 7-16 years, established on corticosteroids, with a North Star Ambulatory Assessment (NSAA) score of 8-34 and able to complete a 10-m walk without aids/assistance. Exclusions: > 20% variation between baseline screens 4 weeks apart and contraindications. INTERVENTIONS: Participants were allocated on a 1 : 1 ratio to (1) optimised, manualised LBT (prescribed by specialist neuromuscular physiotherapists) or (2) the same plus manualised AT (30 minutes, twice weekly for 6 months: active assisted and/or passive stretching regime; simulated or real functional activities; submaximal exercise). Semistructured interviews with participants, parents (n = 8) and professionals (n = 8) were analysed using Framework analysis. An independent rater reviewed patient records to determine the extent to which treatment was optimised. A cost-impact analysis was performed. Quantitative and qualitative data were mixed using a triangulation exercise. MAIN OUTCOME MEASURES: Feasibility of recruiting 40 participants in 6 months, participant and therapist views on the acceptability of the intervention and research protocols, clinical outcomes including NSAA, independent assessment of treatment optimisation and intervention costs. RESULTS: Over 6 months, 348 children were screened - most lived too far from centres or were enrolled in other trials. Twelve (30% of target) were randomised to AT (n = 8) or control (n = 4). People in the AT (n = 8) and control (n = 2: attrition because of parental report) arms contributed outcome data. The mean change in NSAA score at 6 months was -5.5 [standard deviation (SD) 7.8] for LBT and -2.8 (SD 4.1) in the AT arm. One boy suffered pain and fatigue after AT, which resolved the same day. Physiotherapists and parents valued AT and believed that it should be delivered in community settings. The independent rater considered AT optimised for three out of eight children, with other children given programmes that were too extensive and insufficiently focused. The estimated NHS costs of 6-month service were between £1970 and £2734 per patient. LIMITATIONS: The focus on delivery in hospitals limits generalisability. CONCLUSIONS: Neither a full-scale frequentist randomised controlled trial (RCT) recruiting in the UK alone nor a twice-weekly open-ended AT course delivered at tertiary centres is feasible. Further intervention development research is needed to identify how community-based pools can be accessed, and how families can link with each other and community physiotherapists to access tailored AT programmes guided by highly specialised physiotherapists. Bayesian RCTs may be feasible; otherwise, time series designs are recommended. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41002956. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 27. See the NIHR Journals Library website for further project information.

Cluster randomised controlled trial of a financial incentive for mothers to improve breast feeding in areas with low breastfeeding rates: the NOSH study protocol.

INTRODUCTION: Breast feeding can promote positive long-term and short-term health outcomes in infant and mother. The UK has one of the lowest breastfeeding rates (duration and exclusivity) in the world, resulting in preventable morbidities and associated healthcare costs. Breastfeeding rates are also socially patterned, thereby potentially contributing to health inequalities. Financial incentives have been shown to have a positive effect on health behaviours in previously published studies. METHODS AND ANALYSIS: Based on data from earlier development and feasibility stages, a cluster (electoral ward) randomised trial with mixed-method process and content evaluation was designed. The 'Nourishing Start for Health' (NOSH) intervention comprises a financial incentive programme of up to 6 months duration, delivered by front-line healthcare professionals, in addition to existing breastfeeding support. The intervention aims to increase the prevalence and duration of breast feeding in wards with low breastfeeding rates. The comparator is usual care (no offer of NOSH intervention). Routine data on breastfeeding rates at 6-8 weeks will be collected for 92 clusters (electoral wards) on an estimated 10,833 births. This sample is calculated to provide 80% power in determining a 4% point difference in breastfeeding rates between groups. Content and process evaluation will include interviews with mothers, healthcare providers, funders and commissioners of infant feeding services. The economic analyses, using a healthcare provider's perspective, will be twofold, including a within-trial cost-effectiveness analysis and beyond-trial modelling of longer term expectations for cost-effectiveness. Results of economic analyses will be expressed as cost per percentage point change in cluster level in breastfeeding rates between trial arms. In addition, we will present difference in resource use impacts for a range of acute conditions in babies aged 0-6 months. ETHICS AND DISSEMINATION: Participating organisations Research and Governance departments approved the study. Results will be published in peer-reviewed journals and at conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN44898617; Pre-results.

Application of CGEAN's Research Priorities: PhD, DNP Scholarship.

The Accountable Care Act of 2010 is stimulating rapid transformations of healthcare systems. The shift from a focus on providing healthcare in a closed system to improving the health of communities demands rapid innovation by nurse leaders. Nurse leaders prepared at the doctorate of nursing practice level and PhD-prepared nursing health services researchers are needed to develop and evaluate best practices as they emerge. This column expands on the findings from CGEAN's Delphi study.

Encouraging breastfeeding: financial incentives.

The NOSH (Nourishing Start for Health) three-phase research study is testing whether offering financial incentives for breastfeeding improves six-eight-week breastfeeding rates in low-rate areas. This article describes phase one development work, which aimed to explore views about practical aspects of the design of the scheme. Interviews and focus groups were held with women (n = 38) and healthcare providers (n = 53). Overall both preferred shopping vouchers over cash payments, with a total amount of £200-250 being considered a reasonable amount. There was concern that seeking proof of breastfeeding might impact negatively on women and the relationship with their healthcare providers. The most acceptable method to all was that women sign a statement that their baby was receiving breast milk: this was co-signed by a healthcare professional to confirm that they had discussed breastfeeding. These findings have informed the design of the financial incentive scheme being tested in the feasibility phase of the NOSH study.

Healthcare providers' views on the acceptability of financial incentives for breastfeeding: a qualitative study.

BACKGROUND: Despite a gradual increase in breastfeeding rates, overall in the UK there are wide variations, with a trend towards breastfeeding rates at 6-8 weeks remaining below 40% in less affluent areas. While financial incentives have been used with varying success to encourage positive health related behaviour change, there is little research on their use in encouraging breastfeeding. In this paper, we report on healthcare providers' views around whether using financial incentives in areas with low breastfeeding rates would be acceptable in principle. This research was part of a larger project looking at the development and feasibility testing of a financial incentive scheme for breastfeeding in preparation for a cluster randomised controlled trial. METHODS: Fifty-three healthcare providers were interviewed about their views on financial incentives for breastfeeding. Participants were purposively sampled to include a wide range of experience and roles associated with supporting mothers with infant feeding. Semi-structured individual and group interviews were conducted. Data were analysed thematically drawing on the principles of Framework Analysis. RESULTS: The key theme emerging from healthcare providers' views on the acceptability of financial incentives for breastfeeding was their possible impact on 'facilitating or impeding relationships'. Within this theme several additional aspects were discussed: the mother's relationship with her healthcare provider and services, with her baby and her family, and with the wider community. In addition, a key priority for healthcare providers was that an incentive scheme should not impact negatively on their professional integrity and responsibility towards women. CONCLUSION: Healthcare providers believe that financial incentives could have both positive and negative impacts on a mother's relationship with her family, baby and healthcare provider. When designing a financial incentive scheme we must take care to minimise the potential negative impacts that have been highlighted, while at the same time recognising the potential positive impacts for women in areas where breastfeeding rates are low.

The prognostic ability of early Braden Q Scores in critically ill children.

BACKGROUND: Pressure ulcer (PU) risk assessment tools are an important component of good nursing care; however, it is essential that these tools offer a good sensitivity and specificity, in addition to clinical utility in the population being assessed. OBJECTIVES: The aim of this study was to examine how the lowest Braden Q score recorded in the first 24 h of paediatric intensive care unit admission related to the risk of PU development in an English PICU (paediatric intensive care unit). METHODS: A retrospective cohort study was undertaken over 12 months in a single PICU in the North West of England. 891 critically ill children with a Braden Q score were evaluated. The lowest Braden Q score within the first 24 h of PICU admission was matched to reported PU development and grade. RESULTS: The Braden Q score was found to perform well in children aged 3 weeks to 8 years without congenital heart disease (CHD), which is the population it was validated on. At a cut off score of ≤16 it yielded a sensitivity of 100% specificity of 73.1%, positive predictive value (PPV) 2.56 and a negative predictive value (NPV) of 100 and an area under the curve (AUC) of 0.87(0.75-0.98). When used in other age groups and when it included children with CHD, it performed less well with lower AUC and wider confidence intervals, but it performed moderately well in the group of term to 14 years with a sensitivity of 75% specificity of 72.6%, PPV 1.5 and a NPV of 99.8 and AUC of 0.74 (0.49-0.98). CONCLUSION: Our results in a heterogeneous UK PICU population found the Braden Q score performed well in the specific population it was validated for (PICU children aged 3 weeks to 8 years without CHD), however, it performed moderately well in the more heterogonous PICU population of term to 14 years including children with CHD.

Detecting meaningful change using the North Star Ambulatory Assessment in Duchenne muscular dystrophy.

AIM: Clinician-reported outcome instruments such as the North Star Ambulatory Assessment (NSAA) need to be able to detect clinically important change to be suitable for clinical trials. However, in Duchenne muscular dystrophy (DMD), identifying changes in function is not straightforward. In this study, we use Rasch-transformed data to examine the responsiveness and minimal important difference (MID) of the NSAA in males with DMD receiving different corticosteroid regimes. METHOD: NSAA data were examined from 198 males (mean age at assessment was 8 y 6 mo [SD 2 y 6 mo] range 4 y-18 y; 805 assessments). Responsiveness was assessed using mean score changes (using Rasch-transformed data) between adjacent pairs of age groups, pairwise squared t-values from paired samples t-tests, and an effect size calculation. The MID was assessed using the effect size calculation and 0.5 standard deviation (SD) of mean score differences. RESULTS: Our findings revealed a difference in change scores over time between the two corticosteroid regimes. Mean NSAA person estimates were higher in the daily prednisolone group. The mean MID (0.5 SD) was 8.8 and 6.9 for the daily group and intermittent group respectively. INTERPRETATION: This study, based on Rasch-transformed NSAA data, provides an initial basis for the interpretation of clinical change in DMD over time and between corticosteroid regimes. Our proposed MIDs can be mapped back to differences in specific item content across the range of the NSAA.

Crossing our quality chasm: heeding the case for graduate preparation of nurse managers and leaders.

As outlined by the Institute of Medicine's Future of Nursing, it is expected that nurses in direct care will be baccalaureate prepared. What then should be the expectation for educating nurse managers? This article compares the Baccalaureate Essentials with the American Nurses Credentialing Center and American Organization of Nurse Executives certification examination content for nurse managers to evaluate if baccalaureate education prepares these leaders for management roles in order to provide additional support for graduate education of nurse managers.

Development of a functional assessment scale for ambulatory boys with Duchenne muscular dystrophy.

BACKGROUND AND PURPOSE: The aims of this study were to develop a clinical assessment scale to measure functional ability in ambulant boys with Duchenne muscular dystrophy and to determine the reliability of the scale in multiple centres in the UK. METHODS: Focus groups and workshops were held with experienced paediatric neuromuscular physiotherapists to determine scale content. A manual was prepared with accompanying videos, and training sessions were conducted. A total of 17 physiotherapists from participating centres used the videos to determine inter-rater reliability. Five determined the intra-rater reliability. RESULTS: Strength of agreement for these groups based on total subject scores was very good (0.95 and ≥ 0.93 for consistency and absolute agreement, respectively). Test-retest ability was high, with perfect agreement between occasions for all but two items of the scale. CONCLUSIONS: Our study indicates that the North Star Ambulatory Assessment is practical and reliable. It takes only 10 minutes to perform and incorporates both universally used timed tests as well as levels of activities, which allow assessment of high-functioning boys with Duchenne muscular dystrophy.

Moving towards meaningful measurement: Rasch analysis of the North Star Ambulatory Assessment in Duchenne muscular dystrophy.

AIM: Reliable measurement of disease progression and the effect of therapeutic interventions in Duchenne muscular dystrophy (DMD) require clinically meaningful and scientifically sound rating scales. Therefore, we need robust evidence to support such tools. The North Star Ambulatory Assessment (NSAA) is a promising, clinician-rated scale with potential uses spanning clinical practice and clinical trials. In this study, we used Rasch analysis to test its suitability in these roles as a measurement instrument. METHOD: NSAA data from 191 ambulant boys (mean age at assessment 7 y 8 mo, SD 2 y 4 mo; range 3 y 6 mo-15 y 5 mo) with a confirmed diagnosis of DMD were examined for psychometric properties including clinical meaning, targeting, response categories, model fit, reliability, dependency, stability, and raw to interval-level measurement. All analyses were performed using the Rasch Unidimensional Measurement Model. RESULTS: Overall, Rasch analysis supported the NSAA as being a reliable (high Person Separation Index of 0.91) and valid (good targeting, little misfit, no reversed thresholds) measure of ambulatory function in DMD. One item displayed misfit (lifts head, fit residual 6.9) and there was evidence for some local dependency (stand on right/left leg, climb and descend box step right/left leg, and hop on right/left leg, residual correlations >0.40), which we provide potential solutions for in future use of the NSAA. Importantly, our findings supported good clinical validity in that the hierarchy of items within the scale produced by the analyses was supported by clinical opinion, thus increasing the clinical interpretability of scale scores. INTERPRETATION: In general, Rasch analysis supported the NSAA as a psychometrically robust scale for use in DMD clinical research and trials. This study also demonstrates how Rasch analysis is a useful instrument to detect and understand the key measurement issues of rating scales.

Measurement in Duchenne muscular dystrophy: considerations in the development of a neuromuscular assessment tool.

A review of the measures relating to the monitoring of disease progression in Duchenne muscular dystrophy was undertaken as part of the work of the North Star Clinical Network for Paediatric Neuromuscular Disease Management developing a standardized assessment protocol for ambulant children in the UK. This article outlines the process of identifying possible measures. Detailed consideration has been given to key measures of muscle strength and function. As well as the usual assessment of the validity and reliability of the measures, three key characteristics were identified as necessary to the assessment of scales used in health care: (1) the type of scale used; (2) the clinical significance of the attribute being measured; and (3) the mathematical properties of the data provided. Consideration of such aspects in the early stage of a study facilitates the choice of measures, and the analysis and interpretation of data in the longer term.

A hospital care pathway for alcohol.

Inappropriate placing of alcohol misusers on gastroenterology wards spurred the two ward managers into leading a campaign for better diagnosis, placement and treatment of these patients.