The randomized controlled trial (NAVKIDS2) of a patient navigator program created for children with chronic kidney disease.

Patient navigators enable adult patients to circumnavigate complex health systems, improving access to health care and outcomes. Here, we aimed to evaluate the effects of a patient navigation program in children with chronic kidney disease (CKD). In this multi-center, randomized controlled trial, we randomly assigned children (aged 0-16 years) with CKD stages 1-5 (including children on dialysis or with kidney transplants), from low socioeconomic status backgrounds, and/or residing in remote areas, to receive patient navigation at randomization (immediate) or at six months (waitlist). The primary outcome was self-rated health (SRH) of participating children at six months, using intention to treat analysis. Secondary outcomes included caregivers' SRH and satisfaction with health care, children's quality of life, hospitalizations, and missed school days. Repeated measures of the primary outcome from baseline to six months were analyzed using cumulative logit mixed effects models. Semi-structured interviews were thematically evaluated. Of 398 screened children, 162 were randomized (80 immediate and 82 waitlist); mean age (standard deviation) of 8.8 (4.8) years with 64.8% male. SRH was not significantly different between the immediate and wait-listed groups at six months. There were also no differences across all secondary outcomes between the two groups. Caregivers' perspectives were reflected in seven themes: easing mental strain, facilitating care coordination, strengthening capacity to provide care, reinforcing care collaborations, alleviating family tensions, inability to build rapport and unnecessary support. Thus, in children with CKD, self-rated health may not improve in response to a navigator program, but caregivers gained skills related to providing and accessing care.

Advancing randomized controlled trial methodologies: The place of innovative trial design in eating disorders research.

Randomized controlled trials can be used to generate evidence on the efficacy and safety of new treatments in eating disorders research. Many of the trials previously conducted in this area have been deemed to be of low quality, in part due to a number of practical constraints. This article provides an overview of established and more innovative clinical trial designs, accompanied by pertinent examples, to highlight how design choices can enhance flexibility and improve efficiency of both resource allocation and participant involvement. Trial designs include individually randomized, cluster randomized, and designs with randomizations at multiple time points and/or addressing several research questions (master protocol studies). Design features include the use of adaptations and considerations for pragmatic or registry-based trials. The appropriate choice of trial design, together with rigorous trial conduct, reporting and analysis, can establish high-quality evidence to advance knowledge in the field. It is anticipated that this article will provide a broad and contemporary introduction to trial designs and will help researchers make informed trial design choices for improved testing of new interventions in eating disorders. PUBLIC SIGNIFICANCE: There is a paucity of high quality randomized controlled trials that have been conducted in eating disorders, highlighting the need to identify where efficiency gains in trial design may be possible to advance the eating disorder research field. We provide an overview of some key trial designs and features which may offer solutions to practical constraints and increase trial efficiency.

Platform trials for anaesthesia and perioperative medicine: a narrative review.

Large randomised trials provide the most reliable evidence of effectiveness of new treatments in clinical practice. However, the time and resources required to complete such trials can be daunting. An overarching clinical trial platform focused on a single condition or type of surgery, aiming to compare several treatments, with an option to stop any or add in new treatment options, can provide greater efficiency. This has the potential to accelerate knowledge acquisition and identify effective, ineffective, or harmful treatments faster. The master protocol of the platform defines the study population(s) and standardised procedures. Ineffective or harmful treatments can be discarded or study drug dose modified during the life cycle of the trial. Other adaptive elements that can be modified include eligibility criteria, required sample size for any comparison(s), randomisation assignment ratio, and the addition of other promising treatment options. There are excellent opportunities for anaesthetists to establish platform trials in perioperative medicine. Platform trials are highly efficient, with the potential to provide quicker answers to important clinical questions that lead to improved patient care.

Baseline characteristics of participants in the NAVKIDS2 trial: a patient navigator program in children with chronic kidney disease.

BACKGROUND: Children with chronic kidney disease (CKD) require multidisciplinary care to meet their complex healthcare needs. Patient navigators are trained non-medical personnel who assist patients and caregivers to overcome barriers to accessing health services through care coordination. This trial aims to determine the effectiveness of a patient navigator program in children with CKD. METHODS: The NAVKIDS2 trial is a multi-center, waitlisted, randomized controlled trial of patient navigators in children with CKD conducted at five sites across Australia. Children (0-16 years) with CKD from low socioeconomic status rural or remote areas were randomized to an intervention group or a waitlisted control group (to receive intervention after 6 months). The study primary and secondary endpoints include the self-rated health (SRH) (primary), and utility-based quality of life, progression of kidney dysfunction of the child, SRH, and satisfaction with healthcare of the caregiver at 6 months post-randomization. RESULTS: The trial completed recruitment in October 2021 with expected completion of follow-up by October 2022. There were 162 patients enrolled with 80 and 82 patients randomized to the immediate intervention and waitlisted groups, respectively. Fifty-eight (36%) participants were from regional/remote areas, with a median (IQR) age of 9.5 (5.0, 13.0) years, 46% were of European Australian ethnicity, and 65% were male. A total of 109 children (67%) had CKD stages 1-5, 42 (26%) were transplant recipients, and 11 (7%) were receiving dialysis. CONCLUSION: The NAVKIDS2 trial is designed to evaluate the effectiveness of patient navigation in children with CKD from families experiencing socioeconomic disadvantage. A higher resolution version of the Graphical abstract is available as Supplementary information.

A prospective cohort study comparing neonatal outcomes of waterbirth and land birth in an Australian tertiary maternity unit.

BACKGROUND: Maternal preference for warm water immersion (WWI) and waterbirth is increasing, but adoption into obstetric guidelines and clinical practice remains limited. Concerns regarding safety and a paucity of evidence have been cited as reasons for the limited adoption and uptake. AIM: The aim was to investigate maternal and neonatal outcomes after WWI and/or waterbirth compared with land birth. MATERIALS AND METHODS: A prospective cohort study was conducted in an Australian public maternity hospital between 2019 and 2020. Maternal and neonatal outcomes for 1665 women who had a vaginal birth were studied. Primary outcome was admission to the neonatal unit (NNU). Secondary outcomes included neonatal antibiotic administration, maternal intrapartum fever, epidural use and perineal injury. Multivariate logistical regression analyses compared the outcomes between three groups: waterbirth, WWI only and land birth. RESULTS: NNU admissions for a suspected infectious condition were significantly higher in the land birth group (P = 0.035). After accounting for labour duration, epidural use and previous birth mode, no significant difference was detected between groups in the odds of NNU admission (P = 0.167). No babies were admitted to NNU with water inhalation or drowning. Women birthing on land were more likely to be febrile (2 vs 0%; P = 0.007); obstetric anal sphincter injury and postpartum haemorrhage were similar between groups. Regional analgesia use was significantly lower in the WWI group compared to the land birth group (21.02 vs 38.58%; P = <0.001). There was one cord avulsion in the waterbirth group (0.41%). CONCLUSION: Maternal and neonatal outcomes were similar between groups, with no increased risk evident in the waterbirth and WWI groups.

Bayesian adaptive clinical trial designs for respiratory medicine.

The use of Bayesian adaptive designs for clinical trials has increased in recent years, particularly during the COVID-19 pandemic. Bayesian adaptive designs offer a flexible and efficient framework for conducting clinical trials and may provide results that are more useful and natural to interpret for clinicians, compared to traditional approaches. In this review, we provide an introduction to Bayesian adaptive designs and discuss its use in recent clinical trials conducted in respiratory medicine. We illustrate this approach by constructing a Bayesian adaptive design for a multi-arm trial that compares two non-invasive ventilation treatments to standard oxygen therapy for patients with acute cardiogenic pulmonary oedema. We highlight the benefits and some of the challenges involved in designing and implementing Bayesian adaptive trials.

Cost-effectiveness of screening tools for identifying depression in early pregnancy: a decision tree model.

BACKGROUND: Although the effectiveness of screening tools for detecting depression in pregnancy has been investigated, there is limited evidence on the cost-effectiveness. This is vital in providing full information to decision makers. This study aimed to explore the cost-effectiveness of different screening tools to identify depression in early pregnancy compared to no screening. METHODS: A decision tree was developed to model the identification and treatment pathways of depression from the first antenatal appointment to 3-months postpartum using the Whooley questions, the Edinburgh Postnatal Depression Scale (EPDS) and the Whooley questions followed by the EPDS, compared to no screening. The economic evaluation took an NHS and Personal Social Services perspective. Model parameters were taken from a combination of sources including a cross-sectional survey investigating the diagnostic accuracy of screening tools, and other published literature. Cost-effectiveness was assessed in terms of the incremental cost per quality adjusted life years (QALYs). Cost-effectiveness planes and cost-effectiveness acceptability curves were produced using a net-benefit approach based on Monte Carlo simulations of cost-outcome data. RESULTS: In a 4-way comparison, the Whooley, EPDS and Whooley followed by the EPDS each had a similar probability of being cost-effective at around 30% for willingness to pay values from £20,000-30,000 per QALY compared to around 20% for the no screen option. CONCLUSIONS: All three screening approaches tested had a higher probability of being cost-effective than the no-screen option. In the absence of a clear cost-effectiveness advantage for any one of the three screening options, the choice between the screening approaches could be made on other grounds, such as clinical burden of the screening options. Limitations include data availability and short time horizon, thus further research is needed. CLINICAL TRIALS REGISTRATION: N/A.

Psychogenic nonepileptic seizures treated as epileptic seizures in the emergency department.

OBJECTIVES: We aimed to estimate the rate of psychogenic nonepileptic seizures (PNES) among patients presenting to an emergency department with presumed seizures. We also wanted to identify factors that can assist health care professionals in determining whether these events are likely to be epileptic or nonepileptic. METHODS: We performed two retrospective audits on patients who were treated for seizures in the department of emergency medicine at the Princess Alexandra Hospital, Brisbane, Australia. Exploratory analyses and logistic regressions were conducted to investigate the characteristics of the presentations and the relationships between our variables of interest. RESULTS: In the group of all presentations with presumed seizures over a 3-month period (n = 157), a total of 151 presentations (96.2%) presentations were given a primary diagnosis of epileptic seizures. Of these 151 presentations, only 84 (55.6%) presented with epileptic seizures and 40 (26.5%) actually presented with PNES. In the group of patients who presented with prolonged and/or multiple events (n = 213) over a 1-year period, 196 (92.0%) were treated as epileptic seizures. Of these 196 presentations, only 85 (43.4%) presented with epileptic seizures and 97 (49.5%) actually presented with PNES. Several factors were identified to help risk stratify between epileptic seizures and PNES: Duration of events and of the postictal phase, number of events, presence of a structural brain pathology, mental health history, lactate levels and presence of tongue bite, incontinence, and/or vomiting. SIGNIFICANCE: A large proportion of people who present to emergency departments with events resembling epileptic seizures actually have PNES rather than epilepsy-particularly those patients who present with prolonged and/or multiple events. The rate of misdiagnosis was high. Efforts need to be made to recognize patients with psychogenic nonepileptic seizures earlier and diagnose them correctly to avoid unnecessary iatrogenic harm and to provide adequate treatment.

The challenges of trials in reproductive medicine: can a Bayesian approach help?

Reproductive medicine is imbued with debates over the results of key trials. This has resulted in heterogeneity in clinical practice and a disconnect between researchers and the patient group they aim to treat. The criticisms of trials originate from the nature of reproductive health conditions and limitations imposed in designing trials to assess effect in a patient group with heterogenous pathologies leading to the same condition. This leads to challenges in balancing the difficulties of recruiting an enriched patient cohort versus the dilutionary effect and need for subgroup analysis from wider recruitment. These challenges manifest as a failure to achieve traditional statistical significance. One potential solution to overcoming these inherent challenges is that of a Bayesian statistical approach. Using examples from the literature we demonstrate the benefits of a Bayesian approach. Taking published data and using a flat prior (no background information used), a Bayesian re-analysis of the PRISM and EAGeR trials is presented. This demonstrated a 94.7% chance of progesterone and a 95.3% probability of aspirin preventing miscarriage, in contrast to the original trial conclusions. These highlight the role a Bayesian approach can play in overcoming the challenges of trials within reproductive health.

Do we need to adjust for interim analyses in a Bayesian adaptive trial design?

BACKGROUND: Bayesian adaptive methods are increasingly being used to design clinical trials and offer several advantages over traditional approaches. Decisions at analysis points are usually based on the posterior distribution of the treatment effect. However, there is some confusion as to whether control of type I error is required for Bayesian designs as this is a frequentist concept. METHODS: We discuss the arguments for and against adjusting for multiplicities in Bayesian trials with interim analyses. With two case studies we illustrate the effect of including interim analyses on type I/II error rates in Bayesian clinical trials where no adjustments for multiplicities are made. We propose several approaches to control type I error, and also alternative methods for decision-making in Bayesian clinical trials. RESULTS: In both case studies we demonstrated that the type I error was inflated in the Bayesian adaptive designs through incorporation of interim analyses that allowed early stopping for efficacy and without adjustments to account for multiplicity. Incorporation of early stopping for efficacy also increased the power in some instances. An increase in the number of interim analyses that only allowed early stopping for futility decreased the type I error, but also decreased power. An increase in the number of interim analyses that allowed for either early stopping for efficacy or futility generally increased type I error and decreased power. CONCLUSIONS: Currently, regulators require demonstration of control of type I error for both frequentist and Bayesian adaptive designs, particularly for late-phase trials. To demonstrate control of type I error in Bayesian adaptive designs, adjustments to the stopping boundaries are usually required for designs that allow for early stopping for efficacy as the number of analyses increase. If the designs only allow for early stopping for futility then adjustments to the stopping boundaries are not needed to control type I error. If one instead uses a strict Bayesian approach, which is currently more accepted in the design and analysis of exploratory trials, then type I errors could be ignored and the designs could instead focus on the posterior probabilities of treatment effects of clinically-relevant values.

Comparison of Bayesian and frequentist group-sequential clinical trial designs.

BACKGROUND: There is a growing interest in the use of Bayesian adaptive designs in late-phase clinical trials. This includes the use of stopping rules based on Bayesian analyses in which the frequentist type I error rate is controlled as in frequentist group-sequential designs. METHODS: This paper presents a practical comparison of Bayesian and frequentist group-sequential tests. Focussing on the setting in which data can be summarised by normally distributed test statistics, we evaluate and compare boundary values and operating characteristics. RESULTS: Although Bayesian and frequentist group-sequential approaches are based on fundamentally different paradigms, in a single arm trial or two-arm comparative trial with a prior distribution specified for the treatment difference, Bayesian and frequentist group-sequential tests can have identical stopping rules if particular critical values with which the posterior probability is compared or particular spending function values are chosen. If the Bayesian critical values at different looks are restricted to be equal, O'Brien and Fleming's design corresponds to a Bayesian design with an exceptionally informative negative prior, Pocock's design to a Bayesian design with a non-informative prior and frequentist designs with a linear alpha spending function are very similar to Bayesian designs with slightly informative priors.This contrasts with the setting of a comparative trial with independent prior distributions specified for treatment effects in different groups. In this case Bayesian and frequentist group-sequential tests cannot have the same stopping rule as the Bayesian stopping rule depends on the observed means in the two groups and not just on their difference. In this setting the Bayesian test can only be guaranteed to control the type I error for a specified range of values of the control group treatment effect. CONCLUSIONS: Comparison of frequentist and Bayesian designs can encourage careful thought about design parameters and help to ensure appropriate design choices are made.

Prevalence and clinical characterisation of pregnant women with eating disorders.

OBJECTIVE: To estimate prevalence of lifetime and current eating disorders (ED) in a sample of pregnant women in South-East London and to describe their sociodemographic and clinical characteristics. METHOD: Secondary analysis of data from a cross-sectional survey. Using a stratified sampling design, 545 pregnant women were recruited. Diagnostic interviews were administered to assess lifetime and current ED, depression, anxiety, and borderline personality disorder. Data were extracted from maternity records to assess identification of ED in antenatal care. Estimates of population prevalence of ED were obtained using sampling weights to account for the stratified sampling design. RESULTS: Weighted prevalence of lifetime ED was 15.35% (95% confidence interval [CI] [11.80, 19.71]), and current ED was 1.47% (95% CI [0.64, 3.35]). Depression, anxiety, and history of deliberate self-harm or attempted suicide were common in pregnant women with ED. Identification of ED in antenatal care was low. CONCLUSIONS: Findings indicate that by early pregnancy, a significant proportion of pregnant women will have had ED, although less typically during pregnancy, and psychiatric comorbidity is common. Yet ED were poorly recognised in antenatal care. The findings highlight the importance of increasing awareness about maternal ED to improve identification and response to the healthcare needs of pregnant women with ED.

Using Bayesian adaptive designs to improve phase III trials: a respiratory care example.

BACKGROUND: Bayesian adaptive designs can improve the efficiency of trials, and lead to trials that can produce high quality evidence more quickly, with fewer patients and lower costs than traditional methods. The aim of this work was to determine how Bayesian adaptive designs can be constructed for phase III clinical trials in critical care, and to assess the influence that Bayesian designs would have on trial efficiency and study results. METHODS: We re-designed the High Frequency OSCillation in Acute Respiratory distress syndrome (OSCAR) trial using Bayesian adaptive design methods, to allow for the possibility of early stopping for success or futility. We constructed several alternative designs and studied their operating characteristics via simulation. We then performed virtual re-executions by applying the Bayesian adaptive designs using the OSCAR data to demonstrate the practical applicability of the designs. RESULTS: We constructed five alternative Bayesian adaptive designs and identified a preferred design based on the simulated operating characteristics, which had similar power to the original design but recruited fewer patients on average. The virtual re-executions showed the Bayesian sequential approach and original OSCAR trial yielded similar trial conclusions. However, using a Bayesian sequential design could have led to a reduced sample size and earlier completion of the trial. CONCLUSIONS: Using the OSCAR trial as an example, this case study found that Bayesian adaptive designs can be constructed for phase III critical care trials. If the OSCAR trial had been run using one of the proposed Bayesian adaptive designs, it would have terminated at a smaller sample size with fewer deaths in the trial, whilst reaching the same conclusions. We recommend the wider use of Bayesian adaptive approaches in phase III clinical trials. TRIAL REGISTRATION: OSCAR Trial registration ISRCTN, ISRCTN10416500 . Retrospectively registered 13 June 2007.

Psychometric Properties and Factor Structure of a Long and Shortened Version of the Cognitive and Behavioural Responses Questionnaire.

OBJECTIVE: Symptoms of chronic fatigue syndrome (CFS) can be perpetuated by cognitive and behavioral responses to the illness. We aimed to determine the factor structure, reliability, and validity of the 40-item Cognitive and Behavioural Responses Questionnaire (CBRQ) using data gathered from CFS patients. We also propose a short-version CBRQ for greater clinical utility. METHODS: The psychometric analysis was performed on data sets drawn from two sources: a clinical service for CFS patients (n = 576) and the PACE randomized controlled trial of CFS treatments (n = 640). An exploratory factor analysis was conducted on the clinical data set and a confirmatory factor analysis was performed on the randomized controlled trial data set. Using these results, a short version of the CBRQ was proposed. Reliability, metric invariance across age and sex, and construct validity were assessed. RESULTS: The exploratory factor analysis (relative χ = 2.52, root mean square error of approximation = 0.051, comparative fit index = 0.964, Taylor-Lewis Index = 0.942) and confirmatory factor analysis (relative χ = 4.029, root mean square error of approximation = 0.069, comparative fit index = 0.901, Taylor-Lewis Index = 0.892) revealed that eight-factor models fitted the data well. Satisfactory Cronbach's α values were obtained for the final subscales (≥0.76). The shortened CBRQ was obtained by removing items that cross-loaded onto other factors and/or were the lowest loading items in each factor. The shortened CBRQ contained 18 items that had high factor loadings, good face validity, and reliability (Cronbach's α = 0.67-0.88). CONCLUSIONS: The CBRQs, long and short versions, are reliable and valid scales for measuring cognitive and behavioral responses of patients with CFS. Further research is needed to examine the utility of the CBRQ in other long-term conditions.

Accuracy of the Whooley questions and the Edinburgh Postnatal Depression Scale in identifying depression and other mental disorders in early pregnancy.

BACKGROUND: There is limited evidence on the prevalence and identification of antenatal mental disorders. Aims To investigate the prevalence of mental disorders in early pregnancy and the diagnostic accuracy of depression-screening (Whooley) questions compared with the Edinburgh Postnatal Depression Scale (EPDS), against the Structured Clinical Interview DSM-IV-TR. METHOD: Cross-sectional survey of women responding to Whooley questions asked at their first antenatal appointment. Women responding positively and a random sample of women responding negatively were invited to participate. RESULTS: Population prevalence was 27% (95% CI 22-32): 11% (95% CI 8-14) depression; 15% (95% CI 11-19) anxiety disorders; 2% (95% CI 1-4) obsessive-compulsive disorder; 0.8% (95% CI 0-1) post-traumatic stress disorder; 2% (95% CI 0.4-3) eating disorders; 0.3% (95% CI 0.1-1) bipolar disorder I, 0.3% (95% CI 0.1-1%) bipolar disorder II; 0.7% (95% CI 0-1) borderline personality disorder. For identification of depression, likelihood ratios were 8.2 (Whooley) and 9.8 (EPDS). Diagnostic accuracy was similar in identifying any disorder (likelihood ratios 5.8 and 6). CONCLUSIONS: Endorsement of Whooley questions in pregnancy indicates the need for a clinical assessment of diagnosis and could be implemented when maternity professionals have been appropriately trained on how to ask the questions sensitively, in settings where a clear referral and care pathway is available. Declaration of interest L.M.H. chaired the National Institute for Health and Care Excellence CG192 guidelines development group on antenatal and postnatal mental health in 2012-2014.

Principles of Experimental Design for Big Data Analysis.

Big Datasets are endemic, but are often notoriously difficult to analyse because of their size, heterogeneity and quality. The purpose of this paper is to open a discourse on the potential for modern decision theoretic optimal experimental design methods, which by their very nature have traditionally been applied prospectively, to improve the analysis of Big Data through retrospective designed sampling in order to answer particular questions of interest. By appealing to a range of examples, it is suggested that this perspective on Big Data modelling and analysis has the potential for wide generality and advantageous inferential and computational properties. We highlight current hurdles and open research questions surrounding efficient computational optimisation in using retrospective designs, and in part this paper is a call to the optimisation and experimental design communities to work together in the field of Big Data analysis.

Targeted Bleeding Management Reduces the Requirements for Blood Component Therapy in Lung Transplant Recipients.

OBJECTIVE: Lung transplantation is associated with high rates of bleeding and frequent blood transfusion. The authors aimed to determine if point-of-care coagulation testing (POCCT) reduced transfusion requirements. DESIGN, SETTINGS, AND PARTICIPANTS: A before-and-after cohort analysis conducted at a single tertiary referral center. Ninety-three sequential adult patients between January 2010 and January 2014 undergoing isolated lung transplant without preoperative extracorporeal support were analyzed. INTERVENTION: ROTEM and multi-plate POCCT were introduced on July 1, 2012, with an associated algorithm based on the results. MEASUREMENTS AND MAIN RESULTS: Statistically significant decreases in the proportion of patients receiving PRBCs (87% v 65%; p = 0.015), FFP (72% v 30%; p<0.0001) and platelets (70% v 37%; p = 0.002) were found after the intervention. There were small decreases in median chest tube blood loss at 2 hours (300 mLs v 215 mLs; p = 0.03) and 4 hours (440 mLs v 350 mLs; p = 0.050) but not at 12 hours postoperatively. There were no changes in reoperation for bleeding (9% v 4%; p = 0.158) or in-hospital mortality (6% v 2%; p = 0.617). The cost of blood products administered decreased from a median of $3,935.00 to $991.00 (p<0.001). CONCLUSIONS: Use of POCCT in lung-transplant surgery is associated with significant reductions in blood product use and cost. There were no detectable changes in outcome aside from a small decrease in early postoperative bleeding.

Two-year follow-up of the MOSAIC trial: A multicenter randomized controlled trial comparing two psychological treatments in adult outpatients with broadly defined anorexia nervosa.

OBJECTIVE: This study reports follow-up data from a multicenter randomized controlled trial (n = 142) comparing the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with broadly defined anorexia nervosa (AN). At 12 months postrandomization, all patients had statistically significant improvements in body mass index (BMI), eating disorder (ED) symptomatology and other outcomes with no differences between groups. MANTRA was more acceptable to patients. The present study assessed whether gains were maintained at 24 months postrandomization. METHODS: Follow-up data at 24 months were obtained from 73.2% of participants. Outcome measures included BMI, ED symptomatology, distress, impairment, and additional service utilization during the study period. Outcomes were analyzed using linear mixed models. RESULTS: There were few differences between groups. In both treatment groups, improvements in BMI, ED symptomatology, distress levels, and clinical impairment were maintained or increased further. Estimated mean BMI change from baseline to 24 months was 2.16 kg/m(2) for SSCM and 2.25 kg/m(2) for MANTRA (effect sizes of 1.75 and 1.83, respectively). Most participants (83%) did not require any additional intensive treatments (e.g., hospitalization). Two SSCM patients became overweight through binge-eating. DISCUSSION: Both treatments have value as outpatient interventions for patients with AN. © 2016 Crown copyright. International Journal of Eating Disorders. (Int J Eat Disord 2016; 49:793-800).

Implementation outcomes of a digital, trauma-informed care, educational intervention targeting health professionals in a paediatric burns setting: A mixed methods process evaluation.

Trauma-informed care practices are associated with a culture of safety following traumatic experiences, including medical trauma. An interactive, web-based training package ('Responsive CARE') was developed for voluntary uptake by paediatric burns health professionals to increase staff knowledge about trauma-informed practice. This paper reports on a mixed methods process evaluation conducted alongside a preliminary effectiveness study of 'Responsive CARE'. The process evaluation was conducted using The Consolidated Framework for Implementation Research (CFIR) and a logic model, to examine feasibility of both the intervention and implementation strategy. Health practitioners (including senior managers) delivering care to children and caregivers attending an outpatient burns service were eligible to enrol in 'Responsive CARE'. Qualitative interview data and quantitative metadata were used to evaluate the implementation outcomes (adoption, acceptability, fidelity, feasibility and preliminary effectiveness). Children and caregivers attending an outpatient service for change of burn wound dressing or burn scar management during the 3-month control or 3-month intervention period were eligible to enrol in the effectiveness study. The impact on child pain and distress, as well as cost, was investigated using a pretest-posttest design. Thirteen (from anticipated 50 enrolled) health professionals (all female) with mean 10 years (SD=11) of experience with paediatric burns hospital-based outpatient care completed an average of 65% (range 36% to 88%) of available content. Twenty-five semi-structured interviews were completed with health practitioners (21 female) and with 14 caregivers (11 female). Four themes were identified as influencing feasibility and acceptability of the intervention: 1) Keeping a trauma-informed lens; 2) Ways of incorporating trauma-informed care; 3) Working within system constraints; and 4) Being trauma-informed. Preliminary effectiveness data included 177 participants (median age 2 years, and median total body surface area burn 1%). Causal assumptions within the logic model were unable to be fully tested, secondary to lower-than-expected adoption and fidelity. We found no significant difference for pain, distress and per-patient hospital care costs between groups (pre- and post-intervention). Future implementation strategies should include organizational support to keep a trauma-informed lens and to incorporate trauma-informed principles within a medical model of care. Despite efforts to co-design a staff education intervention and implementation approach focused on stakeholder engagement, adaptations are indicated to both the intervention and implementation strategies to promote uptake highlighting the complexity of changing clinician behaviours.

A longitudinal analysis of resting energy expenditure and body composition in people with spinal cord injury undergoing surgical repair of pressure injuries: a pilot study.

BACKGROUND: Data informing energy needs of people with spinal cord injury (SCI) and pressure injuries are scarce, the impact of surgical repair unknown, and the role of body composition in healing unexplored. The study aims were to investigate resting energy expenditure (REE) over the course of pressure injury surgical repair, compare with available energy prediction equations, and explore associations between body composition and wound healing. METHODS: Indirect calorimetry measured REE pre-surgery, post-surgery, at suture removal and hospital discharge. A clinically significant change was defined as +/-10% difference from pre-surgery. Eight SCI-specific energy prediction equations were compared to pre-surgery REE. Wound breakdown (Yes/No), weight, waist circumference (WC), and body composition (fat mass [FM], fat-free mass [FFM], bioimpedance spectroscopy) were measured. RESULTS: Twenty people underwent pressure injury surgical repair (95% male, mean age 56 ± 12 years, 70% paraplegia). Between pre-surgery and discharge, mean REE increased (+118 kcal/d, p = 0.005), but with <10% change at any timepoint. An energy prediction equation incorporating FFM showed greatest agreement (rc = 0.779, 95% CI: 0.437, 0.924). Those with wound breakdown (65%) had a higher weight (12.7 kg, 95% CI: -4.0, 29.3), WC (17.8 cm, 95% CI: -5.1, 40.7), and FM % (36.0% [IQR 31.8, 40.2] vs 26.0% [IQR 15.6, 41.3]) than those without wound breakdown, although statistical significance was not reached. CONCLUSION: The presence of pressure injuries and subsequent surgical repair did not impact REE and energy prediction equations incorporating FFM performed best. While not statistically significant, clinically important differences in body composition were observed in those with wound breakdown.