Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials.

BACKGROUND: Gepotidacin is a novel, bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct mechanism of action and a unique binding site, providing well balanced inhibition of two type II topoisomerase enzymes. Oral gepotidacin is under investigation to treat uncomplicated urinary tract infections. We aimed to compare the efficacy and safety of oral gepotidacin with that of nitrofurantoin in adolescent and adult female individuals with uncomplicated urinary tract infections. METHODS: EAGLE-2 and EAGLE-3 were phase 3, randomised, multicentre, double-blind, double-dummy, non-inferiority (10% margin) trials, in which patients were enrolled at 219 centres worldwide. Patients assigned female at birth, non-pregnant, aged 12 years or older, weighing 40 kg or more, with two or more symptoms of dysuria, frequency, urgency, or lower abdominal pain, and with evidence of urinary nitrite, pyuria, or both were eligible for inclusion. Patients were randomly assigned (1:1) centrally by interactive response technology to receive oral gepotidacin (1500 mg twice daily for 5 days) or oral nitrofurantoin (100 mg twice daily for 5 days), with randomisation stratified by age category and history of recurrent uncomplicated urinary tract infections. Patients, investigators, and the sponsor study team were masked to treatment assignment. The primary endpoint, therapeutic response (success or failure) at test-of-cure (ie, day 10-13), was evaluated in randomly assigned patients with nitrofurantoin-susceptible qualifying uropathogens (≥105 colony-forming units [CFU] per mL) and who received at least one dose of study treatment. Conforming to regulatory guidance, therapeutic success was defined as combined clinical success (ie, complete symptom resolution) and microbiological success (ie, reduction of qualifying uropathogens to <103 CFU/mL) without other systemic antimicrobial use. Safety analyses included patients who were randomly assigned and who received at least one dose of study treatment. The trials are registered with ClinicalTrials.gov, NCT04020341 (EAGLE-2) and NCT04187144 (EAGLE-3), and are completed. FINDINGS: Studies were undertaken from Oct 17, 2019, to Nov 30, 2022 (EAGLE-2), and from April 23, 2020, to Dec 1, 2022 (EAGLE-3). 1680 patients in EAGLE-2 and 1731 patients in EAGLE-3 were screened for eligibility, of whom 1531 and 1605 were randomly assigned, respectively (767 in the gepotidacin group and 764 in the nitrofurantoin group in EAGLE-2, and 805 in the gepotidacin group and 800 in the nitrofurantoin group in EAGLE-3). After an interim analysis, which was prospectively agreed as a protocol amendment, both studies were stopped for efficacy. Thus, the primary analysis population included only patients who, at the time of the interim analysis data cutoff, had the opportunity to reach the test-of-cure visit or were known to not have attained therapeutic success before the test-of-cure visit. In EAGLE-2, 162 (50·6%) of 320 patients assigned gepotidacin and 135 (47·0%) of 287 patients assigned nitrofurantoin had therapeutic success (adjusted difference 4·3%, 95% CI -3·6 to 12·1). In EAGLE-3, 162 (58·5%) of 277 patients assigned gepotidacin and 115 (43·6%) of 264 patients assigned nitrofurantoin had therapeutic success (adjusted difference 14·6%, 95% CI 6·4 to 22·8). Gepotidacin was non-inferior to nitrofurantoin in both studies and superior to nitrofurantoin in EAGLE-3. The most common adverse event with gepotidacin was diarrhoea (observed in 111 [14%] of 766 patients in EAGLE-2 and in 147 [18%] of 804 patients in EAGLE-3), whereas the most common adverse event with nitrofurantoin was nausea (in 29 [4%] of 760 patients in EAGLE-2 and in 35 [4%] of 798 patients in EAGLE-3). Cases were mostly mild or moderate. No life-threatening or fatal events occurred. INTERPRETATION: Gepotidacin is an efficacious oral antibiotic with acceptable safety and tolerability profiles. As a first-in-class investigational oral antibiotic with activity against common uropathogens, including clinically important drug-resistant phenotypes, gepotidacin has the potential to offer substantial benefit to patients. FUNDING: GSK and the US Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.

Intermethod comparability analyses of gepotidacin antimicrobial susceptibility tests using a large collection of globally collected Escherichia coli and Staphylococcus saprophyticus clinical isolates.

Gepotidacin (GSK2140944) is a novel, bactericidal, first in class triazaacenaphthylene bacterial type II topoisomerase inhibitor in development for the treatment of uncomplicated urinary tract infections and gonorrhea. The performance of several antimicrobial susceptibility methods (broth microdilution, gradient diffusion, and disk diffusion) for gepotidacin were evaluated using over 5800 recent Escherichia coli and Staphylococcus saprophyticus clinical isolates. Reference broth microdilution gepotidacin MICs showed an essential agreement of 95.9 % and 98.1 % with MICs by gradient diffusion for E. coli and S. saprophyticus isolates, respectively. Gepotidacin susceptibility using disks produced by 2 manufacturers had good agreement with an R2 values of 0.95 and 99.2 % of overall zone diameters agreeing within 3 mm. A correlation with an overall R2 value of 0.72 between MICs by broth microdilution and zone diameters by disk diffusion was observed. This data should assist in the clinical development of gepotidacin and provide reliable susceptibility methods to evaluate its activity.

Racehorse welfare across a training season.

Racehorse welfare is gaining increasing public attention, however scientific evidence in this area is lacking. In order to develop a better understanding of racehorse welfare, it must be measured and monitored. This is the first study to assess racehorse welfare using scientific objective methods across a training season. The aim of this study was threefold, firstly to investigate welfare measures which could be used in the first welfare assessment protocol for racehorses. Secondly, to understand the effect that a racing and training season had on individual racehorses and thirdly to identify risk factors for both good and poor welfare. Thirteen racehorse training yards were visited at the beginning and the peak of the racing season in England. Behavioral observations along with individual environmental and animal-based welfare measures were carried out on 353 horses in 13 training yards selected for variability. In our sample the horses were generally in good physical health: 94% of horses recorded as an ideal body condition score, no horses had signs of hoof neglect and 77.7% had no nasal discharge. The overall prevalence of external Mouth Corner Lesions was 12.9% and was significantly higher for Flat racing than Jump racing horses. The majority of horses (67.5%) showed positive horse human interactions. When stabled 54.1% horses had physical social contact and nasal discharge was not associated with increased physical contact. The training season significantly affected Human Reactivity Tests, Horse Grimace Scale scores and time spent resting and feeding. A total of 14.5% of horses displayed stereotypic behavior on at least two occasions. Horses with windows in their stables spent more time surveying their surroundings. Overall, in this population of racehorses, horses spent around a third of their daytime feeding (33.7%) followed by time spent standing resting (22.6%). The welfare assessment protocol used in this study is suitable for use in industry to collect welfare data on racehorses.

Antimicrobial Activity of Gepotidacin Tested against Escherichia coli and Staphylococcus saprophyticus Isolates Causing Urinary Tract Infections in Medical Centers Worldwide (2019 to 2020).

The in vitro activities of gepotidacin and comparator agents against 3,560 Escherichia coli and 344 Staphylococcus saprophyticus collected from female (81.1%) and male (18.9%) patients with urinary tract infections (UTIs) in a global prospective surveillance program in 2019 to 2020 were determined. Isolates collected from 92 medical centers in 25 countries, including the United States, Europe, Latin America, and Japan, were tested for susceptibility by reference methods in a central monitoring laboratory. Gepotidacin inhibited 98.0% (3,488/3,560 isolates) of E. coli and 100% (344/344 isolates) of S. saprophyticus at gepotidacin concentrations of ≤4 µg/mL and ≤0.25 µg/mL, respectively. This activity was largely unaffected with isolates that demonstrated resistance phenotypes to other oral standard-of-care antibiotics, including amoxicillin-clavulanic acid, cephalosporins, fluoroquinolones, fosfomycin, nitrofurantoin, and trimethoprim-sulfamethoxazole. Gepotidacin also inhibited 94.3% (581/616 isolates) of E. coli isolates with an extended-spectrum ß-lactamase-producing phenotype, 97.2% (1,085/1,129 isolates) of E. coli isolates resistant to ciprofloxacin, 96.1% (874/899) of E. coli isolates resistant to trimethoprim-sulfamethoxazole, and 96.3% (235/244 isolates) of multidrug-resistant E. coli isolates at gepotidacin concentrations of ≤4 µg/mL. In summary, gepotidacin demonstrated potent activity against a large collection of contemporary UTI E. coli and S. saprophyticus strains collected from patients worldwide. These data support the further clinical development of gepotidacin as a potential treatment option for patients with uncomplicated UTIs.

Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial.

BACKGROUND: Randomised sham-controlled trials of cranial electrostimulation with the Alpha-Stim Anxiety Insomnia and Depression (AID) device have reported improved anxiety and depression symptoms; however, no adequately powered sham-controlled trials in major depression are available. We investigated whether active Alpha-Stim AID is superior to sham Alpha-Stim AID in terms of clinical effectiveness for depression symptoms in major depression. METHODS: The Alpha-Stim-D trial was a multicentre, parallel group, double-blind, randomised controlled trial, recruiting participants from 25 primary care centres in two regions in England, UK. Eligible participants were aged 16 years or older with a current diagnosis of primary major depression, a score of 10-19 on the nine-item Patient Health Questionnaire, and had been offered or prescribed and reported taking antidepressant medication for at least 6 weeks in the previous 3 months. Main exclusion criteria were contraindications to Alpha-Stim AID device use, having persistent suicidal ideation or self-harm, neurological conditions, a substance use disorder or dependence, an eating disorder, bipolar disorder, or non-affective psychosis, or receiving psychological treatment in the past 3 months. Eligible participants were randomly assigned (1:1, minimised by region, anxiety disorder, and antidepressant use) to 1 h daily use of active (100 µA) or sham Alpha-Stim AID treatment for 8 weeks. Randomisation was via an independent web-based system, with participants, outcome assessors, and data analyst masked to treatment assignment. The primary outcome was change from baseline in score on the 17-item Hamilton Depression Rating Scale (HDRS-17, GRID version) at 16 weeks after randomisation, with participants analysed by intention to treat (ITT; all randomly assigned participants). Safety was assessed in all randomly assigned participants. The trial is registered with the ISRCTN registry (ISRCTN11853110); status completed. FINDINGS: Between Sept 8, 2020, and Jan 14, 2022, 236 eligible participants were randomly assigned to active or sham Alpha-Stim AID (n=118 each). 156 (66%) participants were women, 77 (33%) were men, and three (1%) self-reported as other gender; 200 (85%) were White British or Irish; and the mean age was 38·0 years (SD 15·3; range 16-83). 102 (86%) participants in the active Alpha-Stim AID group and 98 (83%) in the sham group were followed up 16 weeks after randomisation. In the ITT population, mean change in GRID-HDRS-17 at 16 weeks was -5·9 (95% CI -7·1 to -4·8) in the active Alpha-Stim AID group and -6·5 (-7·7 to -5·4) in the sham group (mean change difference -0·6 [95% CI -1·0 to 2·2], p=0·46). Among the 236 participants, 17 adverse events were reported in 17 (7%) participants (nine [8%] participants in the active Alpha-Stim AID group; and eight [7%] participants in the sham group). One serious adverse event of suicidal ideation leading to hospitalisation was reported in the sham group, which was judged to be unrelated to the device. INTERPRETATION: Active Alpha-Stim AID was safe and acceptable, but no more clinically effective than sham Alpha-Stim AID in major depression. FUNDING: National Institute for Health Research Applied Research Collaboration East Midlands and Electromedical Products International.

In vitro activity of gepotidacin against urine isolates of Escherichia coli from outpatient departments in Germany.

BACKGROUND: Escherichia coli is the leading pathogen of community-acquired urinary tract infections. Gepotidacin is a novel, bactericidal, first-in-class triazaacenaphthylene oral antibiotic that inhibits bacterial DNA replication by a distinct mechanism of action that confers activity against most strains of target pathogens, such as E. coli, Staphylococcus saprophyticus and Neisseria gonorrhoeae, including those resistant to other antibiotics. OBJECTIVES: This study assessed the in vitro activity of gepotidacin in comparison with ciprofloxacin and other oral standard-of-care antibiotics using a large collection of urine isolates of E. coli obtained from outpatients in Germany. METHODS: Four hundred and sixty E. coli collected from 23 laboratories during a surveillance study in 2019/2020 were tested. Forty-six isolates (10.0%) produced an ESBL of the CTX-M family, half of which belonged to MDR clonal subgroups of E. coli ST131. Antibiotic susceptibilities were tested at a reference laboratory by broth microdilution according to the standard ISO 20776-1. RESULTS: Fifty-three (11.5%) isolates were ciprofloxacin resistant, 25 (47.2%) of which also produced an ESBL. Overall, MIC50/90 values for gepotidacin were 2/4 mg/L (MIC range 0.125-16 mg/L), with no differences in activity between ciprofloxacin-susceptible and ciprofloxacin-resistant isolates, ESBL-producing and non-ESBL isolates, O25b-ST131 isolates, and isolates susceptible or resistant to fosfomycin, mecillinam or nitrofurantoin. CONCLUSIONS: Gepotidacin showed promising in vitro activity against urine isolates of E. coli, including ciprofloxacin-resistant isolates, ESBL-producing isolates and isolates resistant to oral standard-of-care antibiotics.

Prevalence and incidence of diabetes among Aboriginal people in remote communities of the Northern Territory, Australia: a retrospective, longitudinal data-linkage study.

OBJECTIVES: To assess the prevalence and incidence of diabetes among Aboriginal peoples in remote communities of the Northern Territory (NT), Australia. DESIGN: Retrospective cohort analysis of linked clinical and administrative data sets from 1 July 2012 to 30 June 2019. SETTING: Remote health centres using the NT Government Primary Care Information System (51 out of a total of 84 remote health centres in the NT). PARTICIPANTS: All Aboriginal clients residing in remote communities serviced by these health centres (N=21 267). PRIMARY OUTCOME MEASURES: Diabetes diagnoses were established using hospital and primary care coding, biochemistry and prescription data. RESULTS: Diabetes prevalence across all ages increased from 14.4% (95% CI: 13.9% to 14.9%) to 17.0% (95% CI: 16.5% to 17.5%) over 7 years. Among adults (≥20 years), the 2018/2019 diabetes prevalence was 28.6% (95% CI: 27.8% to 29.4%), being higher in Central Australia (39.5%, 95% CI: 37.8% to 41.1%) compared with the Top End region (24.2%, 95% CI: 23.3% to 25.1%, p<0.001). Between 2016/2017 and 2018/2019, diabetes incidence across all ages was 7.9 per 1000 person-years (95% CI: 7.3 to 8.7 per 1000 person-years). The adult incidence of diabetes was 12.6 per 1000 person-years (95% CI: 11.5 to 13.8 per 1000 person-years). CONCLUSIONS: The burden of diabetes in the remote Aboriginal population of the NT is among the highest in the world. Strengthened systems of care and public health prevention strategies, developed in partnership with Aboriginal communities, are needed.

Youth and parent preferences for an ideal AP system: It is all about reducing burden.

BACKGROUND: As new diabetes technologies improve to better manage glucose levels, users' priorities for future technologies may shift to prioritize burden reduction and ease of use. We used qualitative methods to explore youth and parent desired features of an "ideal" artificial pancreas (AP) system. METHODS: We conducted semi-structured interviews with 39 youth, ages 10-25 years, and 44 parents. Interviews were audio-recorded, transcribed, and coded using thematic analysis. RESULTS: Youth (79% female, 82% non-Hispanic white) were (M ± SD) ages 17.0 ± 4.7 years, with diabetes for 9.4 ± 4.9 years, and HbA1c of 8.4 ± 1.1%; 79% were pump-treated and 82% used CGM. Of parents, 91% were mothers and 86% were non-Hispanic white. Participants suggested various ways in which an ideal AP system could reduce physical and emotional burdens of diabetes. Physical burdens could be reduced by lessening user responsibilities to manage glucose for food and exercise, and wear or carry devices. Emotional burden could be reduced by mitigating negative emotional reactions to sound and frequency of alerts, while increasing feelings of normalcy. Youth and parents differed in their suggestions to reduce emotional burden. Participants suggested features that would improve glycemia, but nearly always in the context of how the feature would directly reduce their diabetes-specific burden. CONCLUSIONS: Although participants expressed interest in improving glucose levels, the pervasive desire among suggested features of an ideal AP system was to minimize the burden of diabetes. Understanding and addressing users' priorities to reduce physical and emotional burden will be necessary to enhance uptake and maintain use of future AP systems.

Capturing Beneficial Changes to Racehorse Veterinary Care Implemented during the COVID-19 Pandemic.

In March 2020, the World Health Organisation called for countries to take urgent and aggressive action against a global pandemic caused by COVID-19. Restrictions were introduced in many countries to reduce transmission of COVID-19 and ultimately deaths. Such restrictions have been colloquially referred to as "lockdown". Anecdotal evidence of the beneficial practices that facilitated safe veterinary treatment and equine care had been reported together with an increase in the use of electronic communication and information technologies during the first "lockdown". Thus, the aim of this qualitative study was to capture any beneficial changes to racehorse veterinary care that were implemented during the first "lockdown" period in the UK that lasted from 23 March to 12 May 2020. Ten equine veterinary surgeons who primarily treat racehorses and 10 racehorse trainers were interviewed either by telephone or by videoconferencing. After using thematic analysis from a critical realist social constructionist perspective, four themes were identified. These were, firstly, according to our participants, the trainer-vet relationship is predicated upon a good working relationship, secondly, there had been little or no change in the vet-trainer relationship during the first "lockdown" period. Thirdly, when COVID-19 restrictions were in force, more remote consultations took place using images or videos as well as telephone consults, viewed favourably by both trainers and vets, and finally, intermittent connectivity and poor-quality images and videos limited their effectiveness. In order to fully benefit from the positive changes employed by some vets and trainers in their working relationships, we recommend that rural connectivity is prioritised.

Associations of diabetes self-management characteristics, HbA1c, and psychosocial outcomes with depressive symptoms in a contemporary sample of adolescents with type 1 diabetes.

AIMS: We sought to examine the associations between diabetes self-management, HbA1c, and psychosocial outcomes with the frequency of depressive symptoms. METHODS: We surveyed 301 teens (50% male, 22% non-white), mean age of 15.0±1.3 years, diabetes duration of 6.5±3.7 years. Biomedical variables: daily frequency of blood glucose monitoring of 4.5±1.9, 63% insulin pump use, mean HbA1c 8.5±1.1% (69±12 mmol/mol); 15% of the sample achieved the target HbA1c of <7.5% (<58 mmol/mol). RESULTS: Nearly 1 in 5 (18%, n=54) adolescents reported significant depressive symptoms and, of those participants, slightly under half reported moderate/severe depressive symptoms. Teens with moderate/severe depressive symptoms (CES-D scores ≥24) were more likely to be female, have parents without a college education, and not utilize insulin pumps. Teens with more depressive symptoms reported higher diabetes family conflict, higher diabetes burden, and lower quality of life. In the group reporting no depressive symptoms (10%), scores on psychosocial variables and diabetes treatment variables were the most favorable. CONCLUSION: In our sample, the presence of depressive symptoms appears to relate to both diabetes treatment and quality of life. In addition, studying teens without depressive symptoms can help us learn more about protective factors that potentially buffer against depressive symptoms and that are associated with better outcomes.

Mental Health Providers' Assessment of Parents' Reactions to their Children's Elevated Depressive Symptoms.

This study assessed parental reactions to the report of elevated depressive symptoms in a sample of 29 youth with type 1 diabetes (ages 8-17 years; 48% female) who scored ≥15 on the Center for Epidemiologic Studies Depression Scale for Children (CES-DC). We also assessed parental depressive symptoms and how the presence of such symptoms was linked to parental reactions to the report of a positive screening score in their children and subsequent acceptance of a mental health referral. Mental health professionals contacted parents to discuss elevated scores and offer a mental health referral. Two coders reviewed the documentation of phone contacts made by mental health professionals and categorized parental responses to their child's elevated CES-DC score and the disposition plan. Youth and parent depressive symptoms were modestly correlated (r = 0.21, P = .01). About half (55%, 16/29) of parents were unaware of their child's depressive symptoms. Only 14% (4/29) of youth were already receiving mental health care while 28% (8/29) of parents accepted a referral. Parents with depressive symptoms were frequently unaware of their child's symptoms. Findings provide insight into parental reactions to learning of their child's depressive symptoms and highlight the need for more research on parental mood and reactions to their child's positive screen for depressive symptoms, as a potential barrier to mental health referral acceptance.

Innovative features and functionalities of an artificial pancreas system: What do youth and parents want?

AIMS: Participant-driven solutions may help youth and families better engage and maintain use of diabetes technologies. We explored innovative features and functionalities of an ideal artificial pancreas (AP) system suggested by youth with type 1 diabetes and parents. METHODS: Semi-structured interviews were conducted with 39 youth, ages 10-25 years, and 44 parents. Interviews were recorded, transcribed and coded using thematic analysis. RESULTS: Youth (72% female, 82% non-Hispanic white) were (M ± SD) ages 17.0 ± 4.7 years, with diabetes for 9.4 ± 4.9 years, and HbA1c of 68 ± 11 mmol/mol (8.4 ± 1.1%); 79% were pump-treated and 82% were continuous glucose monitor users. Of parents, 91% were mothers and 86% were non-Hispanic white, with a child 10.6 ± 4.5 years old. Youth and parents suggested a variety of innovative features and functionalities for an ideal AP system related to (1) enhancing the appeal of user interface, (2) increasing automation of new glucose management functionalities, and (3) innovative and commercial add-ons for greater convenience. Youth and parents offered many similar suggestions, including integration of ketone testing, voice activation, and location-tracking into the system. Youth seemed more driven by increasing convenience and normalcy while parents expressed more concerns with safety. CONCLUSIONS: Youth and parents expressed creative solutions for an ideal AP system to increase ease of use, enhance normalcy, and reduce burden of management. Designers of AP systems will likely benefit from incorporating the desired preferences by end users to optimize acceptance and usability by young persons with diabetes.

Text Message Intervention for Teens with Type 1 Diabetes Preserves HbA1c: Results of a Randomized Controlled Trial.

Aims: Teens with type 1 diabetes (T1D) often struggle with diabetes self-management, which may lead to suboptimal self-care and worsening hemoglobin A1c (HbA1c). Innovative strategies are needed to improve self-care and protect against glycemic decline, especially during adolescence. We aimed to assess the impact on HbA1c of two interventions, problem-solving and text messaging, in teens with T1D. Methods: In a two-site randomized controlled trial, teens (N = 301) 13-17 years of age with T1D were randomized to one of the four groups using a 2 × 2 factorial design: Teenwork (TW), Text Messaging (Text), TW+Text, or Usual Care. TW intervention included problem-solving aimed at improving T1D self-care for blood glucose (BG) monitoring and insulin bolus dosing. Text intervention involved text reminders to check BG. The primary outcome was change in HbA1c from baseline to 12 months. Results: At baseline, teens (51% female, 78% white, 59% pump-treated) were (mean ± SD) 15.0 ± 1.3 years, had diabetes duration of 6.5 ± 3.7 years, and HbA1c 8.5% ± 1.1%. There was no significant difference in HbA1c over time by study group. Responsiveness to text reminders by teens in the TEXT and TW+TEXT predicted glycemic benefit; TW did not. Conclusions: Despite no HbA1c difference by study group, greater response to text message reminders to check BG led to better glycemic control and no deterioration in HbA1c; the problem-solving intervention did not. Given the high penetration of mobile phones and the wide acceptance of text messaging among teens in general, it is encouraging that a text messaging intervention can preserve HbA1c, thus preventing the expected deterioration in glycemic control often seen in teens with T1D.

Play-Based Interventions Delivered by Child Life Specialists: Teachable Moments for Youth With Type 1 Diabetes.

INTRODUCTION: Certified child life specialists (CCLSs) are health care team members with advanced knowledge of child development. CCLSs can help establish a trajectory of engagement in diabetes self-management beginning in early childhood. METHOD: This article describes the child life interventions delivered in a pediatric diabetes clinic from 2003 to 2018. RESULTS: Over the 16 years, there were 43,549 child life interventions, grouped into six categories: medical play, developmentally appropriate recreational play, therapeutic activities, health education, coping and coaching support, and procedural support. Child life interventions occurred within the pediatric clinic in either the playroom, laboratory, or examination rooms. The CCLS team also organizes other events throughout each year, such as the Teddy Bear Clinic, to maintain child and family engagement. DISCUSSION: CCLSs may improve the experience of a child living with diabetes, setting the stage for a future that maintains engagement in self-care and encourages good health.

Necessary but not sufficient: identifying conditions for effective feedback during internal medicine residents' clinical education.

Competency-based medical education and programmatic assessment intend to increase the opportunities for meaningful feedback, yet these conversations remain elusive. By comparing resident and faculty perceptions of feedback opportunities within one internal medicine residency training program, we sought to understand whether and how principles underlying meaningful feedback could be supported or constrained across a variety of feedback opportunities. Using case-study qualitative methodology, interviews and focus groups were conducted to explore 19 internal medicine residents' and 7 faculty members' perceptions of feedback across a variety of feedback opportunities: coaching, mini-CEXs, in-training evaluation reports and routine clinical supervision. Our data analysis moved iteratively between developing conceptual understandings and fine-grained analyses, while attending to both deductive and inductive analysis. Our results suggest that all feedback opportunities, including those created through formalized assessments, can foster meaningful feedback if faculty establish a trusting relationship with the resident, base their feedback on direct observation and support resident learning. However, formalized assessments were often perceived as inhibiting the conditions for meaningful feedback. A coaching program provided a context in which meaningful feedback could arise, in part because faculty were supported in shifting their focus from patient to resident. Meaningful feedback in clinical education may be fostered across a variety of feedback opportunities, however, it is often constrained by assessment. We must consider whether increasing the frequency of formative assessments may inhibit efforts to improve our feedback cultures while, in contrast, freeing up faculty to focus on supporting resident learning could improve these cultures.

Stakeholder Perceptions of the Challenges to Racehorse Welfare.

The purpose of this paper is to highlight some of the key challenges to racehorse welfare as perceived by racing industry stakeholders. The paper draws upon statements and transcripts from 10 focus group discussions with 42 participants who were taking part in a larger study investigating stakeholders' perceptions of racehorse welfare, which participants recognised as maintaining the physical and mental well-being of a performance animal. Analysis of the 68 statements participants identified as challenges produced nine themes. Among these, 26% (18 statements) of the challenges were health related, whilst 41% (28 statements) focused on the effect staff shortages were having on the racing industry. Staff shortages were perceived as affecting standards of racehorse care and the opportunity to develop a human-horse relationship. Poor employee relations due to a lack of recognition, communication and respect were perceived as having a detrimental effect on employee attitudes, behaviour and staff retention which, in turn, can have a sequential effect on the welfare and health of horses in training. Although the number of challenges produced is small (68), they emphasise the perceptions of stakeholders closely associated with the racing industry.

Living the 'Best Life' or 'One Size Fits All'-Stakeholder Perceptions of Racehorse Welfare.

The purpose of the study was to explore the perceptions held by British racing industry stakeholders of factors influencing racehorse welfare. Ten focus groups were held across the UK with a total of 42 stakeholders from a range of roles within racehorse care including trainers, stable staff and veterinarians. Participants took part in three exercises. Firstly, to describe the scenarios of a 'best life' and the minimum welfare standards a horse in training could be living under. Secondly, to identify the main challenges for racehorse welfare and thirdly, to recall any innovative or uncommon practices to improve welfare they had witnessed. Using thematic analysis, eight themes emerged from the first exercise. Two strands, factors that contribute to maintaining health and the horse-human relationship ran through all eight themes. Across all themes horses living the 'best life' were perceived as being treated as individuals rather than being part of a 'one size fits all' life when kept under minimum welfare standards. Health was both perceived as the main challenge to welfare as well as one open to innovative practices such as improved veterinary treatments. Data obtained, informed by the knowledge and expertise of experienced stakeholders, combined with practical animal welfare science will be used to develop the first British racehorse welfare assessment protocol.

Working in the dead of night: exploring the transition to after-hours duty.

CONTEXT: Transitions, although often difficult, represent integral components of medical training. New postgraduate trainees (first-year residents) find themselves in an especially challenging transition as they are expected to fulfil both learning and service expectations concurrently. Workplace learning theory has been suggested as a lens through which to understand this unique educational, yet service-oriented, role. This tension may be further amplified overnight when residents are on-call with little to no support. OBJECTIVES: The aims of this study were to explore the transition from medical student to resident with respect to the on-call experience, and to provide theory-based suggestions to enhance learning during this unique transition. METHODS: We conducted an interpretivist qualitative study by interviewing eight medical students and 10 first-year residents from six different specialty training programmes across four academic sites. Each semi-structured interview was transcribed verbatim and anonymised. Resident interview transcripts were initially coded for major themes, after which medical student interview transcripts were coded for consistencies and discrepancies. RESULTS: Four interrelated themes were identified in students' and residents' descriptions of on-call experiences: (i) shift in responsibility; (ii) supervisory support; (iii) contextual conditions, and (iv) clarity of expectations. Generally, students were not able to anticipate the challenges they would face as residents on-call, and residents perceived the transition as sudden with little emphasis placed on learning. CONCLUSIONS: First-year residents face multiple challenges during on-call, which may prevent optimal learning in this setting. These challenges are amplified by the large gap between the respective roles of medical students and residents. We identified promoters of and barriers to effective learning in this environment and, by using workplace learning theory, provide recommendations for how we might be able to enhance medical students' preparation for and first-year residents' learning during experiences of being on-call.

Baseline Psychosocial Characteristics Predict Frequency of Continuous Glucose Monitoring in Youth with Type 1 Diabetes.

BACKGROUND: Consistent use of continuous glucose monitoring (CGM) has been associated with improved glycemic control in youth with type 1 diabetes (T1D). There are many barriers to device uptake and continued use. There is a need to understand patient-specific characteristics when considering CGM. We evaluated patterns of CGM use and associations between baseline psychosocial measures and frequency of CGM use over 1 year. METHODS: Youth with T1D (n = 120), ages 8-18 years, completed questionnaires at CGM initiation and after 6 and 12 months assessing depressive symptoms, diabetes burden, and diabetes-specific and generic quality of life (QOL). RESULTS: Youth (51% male and 95% white) had mean age 12.7 ± 2.7 years, diabetes duration 6.1 ± 3.6 years, and glycated hemoglobin (HbA1c) 8.0 ± 0.8%. Over 1 year, 35% of youth used CGM 6 to 7 days per week, 45% used CGM 3-5 days per week, and 20% used CGM only 0-2 days per week. Youth who used CGM 3-7 days per week over 12 months had lower HbA1c at months 9 and 12 than youth who used CGM 0-2 days per week (9 months: 7.9 ± 0.9% vs. 8.5 ± 1.1%, P = 0.006 and 12 months: 8.0 ± 0.9% vs. 8.5 ± 1.1%, P = 0.02). Those using CGM 0-2 days per week had greater endorsement of depressive symptoms and diabetes burden and reported lower QOL at baseline compared with those using CGM 3-7 days per week. CONCLUSIONS: CGM use for 3 or more days per week over 12 months had a protective effect on HbA1c. Providers should consider addressing psychosocial parameters when initiating CGM to maximize uptake and promote continued use in youth with T1D.

Associations between major life events and adherence, glycemic control, and psychosocial characteristics in teens with type 1 diabetes.

AIMS: This cross-sectional study assessed the type of major life events occurring in a contemporary sample of teens with type 1 diabetes and the association between event frequency and demographic, diabetes management, and psychosocial characteristics. METHODS: Parents of 178 teens completed the Life Events Checklist to report major events teens had experienced in the last year: 42% experienced 0 to 1 event (n = 75), 32% experienced 2 to 3 events (n = 57), and 26% experienced 4+ events (n = 46). Teens and parents completed validated measures of treatment adherence, diabetes-specific self-efficacy, quality of life, and diabetes-specific family conflict. Parent-youth interview and chart review provided demographics and diabetes management data. RESULTS: Mean number of events/teen was 2.6 ± 2.7 (range = 0-15). The most common events were "Hospitalization of a family member" (24%), "Getting a bad report card" (20%), "Serious arguments between parents" (19%), and "Serious illness/injury in a family member" (19%). Compared with teens experiencing 0 to 1 event, teens experiencing 4+ events were less likely to have married parents (P = .01) and a parent with a college degree (P = .006). Teens with 4+ events had significantly poorer adherence (P = .002 teen, P = .02 parent), lower self-efficacy (P = .03 teen, P < .0001 parent), poorer quality of life (P < .0001 teen, P < .0001 parent), and more conflict (P = .006 teen, P = .02 parent) than teens with fewer events. In a multivariate model (R 2 = 0.21, P < .0001) controlling for demographic and diabetes management characteristics, fewer events was associated with lower A1c (P = .0009). CONCLUSIONS: Occurrence of more major life events was associated with poorer diabetes care and A1c and more negative psychosocial qualities in teens with type 1 diabetes.