Why surveys are 'very hard': exploring challenges and insights for collection of authentic patient experience information with speakers of Australian First Nations languages.

INTRODUCTION: Health services collect patient experience data to monitor, evaluate and improve services and subsequently health outcomes. Obtaining authentic patient experience information to inform improvements relies on the quality of data collection processes and the responsiveness of these processes to the cultural and linguistic needs of diverse populations. This study explores the challenges and considerations in collecting authentic patient experience information through survey methods with Australians who primarily speak First Nations languages. METHODS: First Nations language experts, interpreters, health staff and researchers with expertise in intercultural communication engaged in an iterative process of critical review of two survey tools using qualitative methods. These included a collaborative process of repeated translation and back translation of survey items and collaborative analysis of video-recorded trial administration of surveys with languages experts (who were also receiving dialysis treatment) and survey administrators. All research activities were audio- or video-recorded, and data from all sources were translated, transcribed and inductively analysed to identify key elements influencing acceptability and relevance of both survey process and items as well as translatability. RESULTS: Serious challenges in achieving equivalence of meaning between English and translated versions of survey items were pervasive. Translatability of original survey items was extensively compromised by the use of metaphors specific to the cultural context within which surveys were developed, English words that are familiar but used with different meaning, English terms with no equivalent in First Nations languages and grammatical discordance between languages. Discordance between survey methods and First Nations cultural protocols and preferences for seeking and sharing information was also important: the lack of opportunity to share the 'full story', discomfort with direct questions and communication protocols that preclude negative or critical responses constrained the authenticity of the information obtained through survey methods. These limitations have serious implications for the quality of information collected and result in frustration and distress for those engaging with the survey. CONCLUSION: Profound implications for the acceptability of a survey tool as well as data quality arise from differences between First Nations cultural and communication contexts and the cultural context within which survey methods have evolved. When data collection processes are not linguistically and culturally congruent there is a risk that patient experience data are inaccurate, miss what is important to First Nations patients and have limited utility for informing relevant healthcare improvement. Engagement of First Nations cultural and language experts is essential in all stages of development, implementation and evaluation of culturally safe and effective approaches to support speakers of First Nations languages to share their experiences of health care and influence change.

Pharmacotherapy and Lung Function Decline in Patients with Chronic Obstructive Pulmonary Disease. A Systematic Review.

Rationale: Whether pharmacological therapy alters decline in FEV1 in chronic obstructive pulmonary disease remains controversial. Because pharmacotherapy improves health status, exacerbation rate, and symptoms, it may be unethical to complete placebo-controlled long-term studies aimed at modifying FEV1 decline.Objectives: We conducted a systematic review of placebo-controlled pharmacological trials lasting ≥1 year to address the question of whether therapy alters FEV1 decline.Methods: A literature search for randomized trials that included repeated spirometry with at least one active and one placebo arm was conducted. Articles were excluded if study duration was <1 year, <3 spirometric measurements, or <100 subjects per arm. Study design was assessed using the Jadad score. To combine studies and find the estimated effect, we used random effects methodology to account for both within-study and between-study variation.Measurements and Main Results: There were 33,051 patients in the analysis (active component, n = 21,941; placebo, n = 11,110 in nine studies). The active treatment arms demonstrated a 5.0 ml/yr reduction (95% confidence interval, 0.8-9.1 ml/yr; P < 0.001) in the rate of FEV1 decline compared with the placebo arms. The relative FEV1 differences between active and placebo arms were within the range of differences reported for health status and for the exacerbation rate in the same studies.Conclusions: In chronic obstructive pulmonary disease, pharmacotherapy ameliorates rate of lung function decline. The relative benefit observed is within the range of those reported for health status and exacerbations in the same studies. Guidelines should be adjusted according to these findings.

Multiecho complex total field inversion method (mcTFI) for improved signal modeling in quantitative susceptibility mapping.

PURPOSE: Typical quantitative susceptibility mapping (QSM) reconstruction steps consist of first estimating the magnetization field from the gradient-echo images, and then reconstructing the susceptibility map from the estimated field. The errors from the field-estimation steps may propagate into the final QSM map, and the noise in the estimated field map may no longer be zero-mean Gaussian noise, thus, causing streaking artifacts in the resulting QSM. A multiecho complex total field inversion (mcTFI) method was developed to compute the susceptibility map directly from the multiecho gradient echo images using an improved signal model that retains the Gaussian noise property in the complex domain. It showed improvements in QSM reconstruction over the conventional field-to-source inversion. METHODS: The proposed mcTFI method was compared with the nonlinear total field inversion (nTFI) method in a numerical brain with hemorrhage and calcification, the numerical brains provided by the QSM Challenge 2.0, 18 brains with intracerebral hemorrhage scanned at 3T, and 6 healthy brains scanned at 7T. RESULTS: Compared with nTFI, the proposed mcTFI showed more accurate QSM reconstruction around the lesions in the numerical simulations. The mcTFI reconstructed QSM also showed the best image quality with the least artifacts in the brains with intracerebral hemorrhage scanned at 3T and healthy brains scanned at 7T. CONCLUSION: The proposed multiecho complex total field inversion improved QSM reconstruction over traditional field-to-source inversion through better signal modeling.

Prioritization of Pesticides for Assessment of Risk to Aquatic Ecosystems in Canada and Identification of Knowledge Gaps.

Pesticides can enter aquatic environments via direct application, via overspray or drift during application, or by runoff or leaching from fields during rain events, where they can have unintended effects on non-target aquatic biota. As such, Fisheries and Oceans Canada identified a need to prioritize current-use pesticides based on potential risks towards fish, their prey species, and habitats in Canada. A literature review was conducted to: (1) Identify current-use pesticides of concern for Canadian marine and freshwater environments based on use and environmental presence in Canada, (2) Outline current knowledge on the biological effects of the pesticides of concern, and (3) Identify general data gaps specific to biological effects of pesticides on aquatic species. Prioritization was based upon recent sales data, measured concentrations in Canadian aquatic environments between 2000 and 2020, and inherent toxicity as represented by aquatic guideline values. Prioritization identified 55 pesticides for further research nationally. Based on rank, a sub-group of seven were chosen as the top-priority pesticides, including three herbicides (atrazine, diquat, and S-metolachlor), three insecticides (chlorpyrifos, clothianidin, and permethrin), and one fungicide (chlorothalonil). A number of knowledge gaps became apparent through this process, including gaps in our understanding of sub-lethal toxicity, environmental fate, species sensitivity distributions, and/or surface water concentrations for each of the active ingredients reviewed. More generally, we identified a need for more baseline fish and fish habitat data, ongoing environmental monitoring, development of marine and sediment-toxicity benchmarks, improved study design including sufficiently low method detection limits, and collaboration around accessible data reporting and management.

"It was one of those complicated cases": health practitioners' perspectives and practices of providing end-of-life care for people with profound intellectual and multiple disability.

BACKGROUND: Due to developments in health and social care, people with profound intellectual and multiple disability (PIMD) are living longer than ever before, meaning they are increasingly experiencing life-threatening health conditions requiring palliative care. Little is known about providing end-of-life care for people with PIMD. The aim of this study was to explore health practitioners' perspectives and practices relating to end-of-life decision-making and planning for people with PIMD. METHODS: Seven in-depth semi-structured interviews were conducted with health practitioners employed in a range of hospital and community services throughout Melbourne, Australia. Questions were designed to gather information about their experience, perceptions, and attitudes relating to people with PIMD during and at the end of their life. Each interview, ranging from 40 to 60 min in length, was audio recorded and transcribed. Inductive thematic analysis was used to analyse the data. RESULTS: Four main themes emerged: limited participation, bias, dignity, and quality of death. Health practitioners indicated that people with PIMD are frequently excluded from participating in decision-making related to end-of-life care. Participants discussed reasons for this exclusion including challenges with communication and cognition. Participants reported a need for additional support and guidance in providing care for people with PIMD at the end of life. Professional and family bias played a role in end-of-life decision-making for people with PIMD. Participants reported a disproportional focus by palliative care practitioners on physical as opposed to emotional and spiritual well-being for patients with PIMD at the end of life. Finally, participants reported that people with PIMD generally did not die in specialised palliative care settings, but in segregated supported living environments. CONCLUSIONS: Due to negative perceptions of a person with PIMD's decision-making capacity, people with PIMD are likely to be assessed as unable to express choice and preference regarding end-of-life care and are offered limited opportunity to be involved in their own end-of-life care. This research provides guidance for the development of training and professional development relating to people with PIMD at the end of life. It is hoped that this will increase the accessibility of end-of-life services for people with PIMD, ensuring that a respectful and dignified death can be a reality for all humankind regardless of disability.

Active travelling to school is not associated with increased total daily physical activity levels, or reduced obesity and cardiovascular/pulmonary health parameters in 10-12-year olds: a cross-sectional cohort study.

BACKGROUND/OBJECTIVES: Childhood obesity has increased enormously. Several lifestyle factors have been implicated, including decreased physical activity, partially involving a decline in active travel to school. We aimed to establish the association between school transport mode and physical activity levels of primary 6 and 7 children (aged 10-12). Secondary outcomes were body mass index standard deviation scores, blood pressure levels and lung function. SUBJECTS/METHODS: A cross-sectional study was conducted with a total number of 432 children from three primary schools in North East Scotland. Actigraph accelerometers were used to provide objective measures of physical activity. Ninety-two children in primary 6 and 90 children in primary 7 (40 in common) had adequate data. Modes of transport to school were assessed by a questionnaire. Two hundred and seventeen children in primary 6 and one hundred and sixty-five in primary 7 returned adequate questionnaires. Children who used active transport modes for >70% of their journeys to school over the week were coded as active travellers and <30% were coded as passive travellers. All children also had height, weight, blood pressure levels and lung function measured. RESULTS: Children who lived further away from school, and in more expensive properties were more likely to travel passively to school. Actively commuting children (70% walking) had significantly higher activity levels than passive commuters during the 30 min that encompassed their journey to and from school. However, there were no significant differences between active and passive school travellers in total daily physical activity, BMI SDS, and both systolic and diastolic blood pressure and lung function. CONCLUSIONS: There was no evidence that more days of active travel to school had a significant influence on total physical activity, obesity and related health parameters. Public health interventions promoting active travel to school may have limited success in quelling the childhood obesity epidemic.

Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial.

BACKGROUND: Adjudicated cause-specific mortality has been used in major trials of chronic obstructive pulmonary disease. However, there is less experience with adjudicated major adverse cardiovascular events as a key efficacy outcome in chronic obstructive pulmonary disease trials. The Study to Understand Mortality and Morbidity in chronic obstructive pulmonary disease trial required a Clinical Endpoint Committee to adjudicate the outcomes of modified major adverse cardiovascular events and cause-specific mortality. METHODS AND RESULTS: A six-member Clinical Endpoint Committee reviewed adverse event and serious adverse event reports included in a list of 204 Medical Dictionary for Regulatory Activities terms. Adverse events were triaged by one Clinical Endpoint Committee member, and then reviewed by three reviewers (round 1). If these three disagreed on the adjudication, the event was discussed by the full committee to reach a consensus (round 2). Among 16,485 participants, 48,105 adverse events were reported, among which 3314 were reviewed by the Clinical Endpoint Committee. After triage, 1827 were adjudicated in round 1; 338 required committee consensus in round 2, yielding 450 myocardial infarctions, strokes, unstable anginas or transient ischaemic attacks. Only 20/1627 (1%) non-serious adverse events were adjudicated as cardiovascular events. Only 45/204 Medical Dictionary for Regulatory Activities terms reviewed yielded cardiovascular events. A total of 430 deaths were adjudicated in round 1 and 631 in round 2, yielding 459 cardiovascular deaths. Adjudication of chest pain and sudden death often required additional information from site investigators. Site assessment of cardiovascular death was moderately specific (501/602 = 83%) but not sensitive (256/459 = 56%). CONCLUSION: A Clinical Endpoint Committee is useful for adjudication of major adverse cardiovascular events in chronic obstructive pulmonary disease trials but requires considerable resources and effort by investigators. This process can be streamlined by reviewing only serious adverse events and filtering by selected Medical Dictionary for Regulatory Activities terms.

The effects of financial incentives on diabetes prevention program attendance and weight loss among low-income patients: the We Can Prevent Diabetes cluster-randomized controlled trial.

BACKGROUND: Penetration and participation of real life implementation of lifestyle change programs to prevent type 2 diabetes has been challenging. This is particularly so among low income individuals in the United States. The purpose of this study is to examine the effectiveness of financial incentives on attendance and weight loss among Medicaid beneficiaries participating in the 12-month Diabetes Prevention Program (DPP). METHODS: This is a cluster-randomized controlled trial with two financial incentive study arms and an attention control study arm. Medicaid beneficiaries with prediabetes from 13 primary care clinics were randomly assigned to individually earned incentives (IND; 33 groups; n = 309), a hybrid of individual- and group-earned incentives (GRP; 30 groups; n = 259), and an attention control (AC; 30 groups; n = 279). Up to $520 in incentives could be earned for attaining attendance and weight loss goals over 12 months. Outcomes are percent weight loss from baseline, achieving 5% weight loss from baseline, and attending 75% of core and 75% of maintenance DPP sessions. Linear mixed models were used to examine weight change and attendance rates over the 16 weeks and 12 months. RESULTS: The percent weight change at 16 weeks for the IND, GRP, and AC participants were similar, at - 2.6, - 3.1%, and - 3.4%, respectively. However, participants achieving 5% weight loss in the IND, GRP, and AC groups was 21.5, 24.0% (GRP vs AC, P < 0.05), and 15.2%. Attendance at 75% of the DPP core sessions was significantly higher among IND (60.8%, P < 0.001) and GRP (64.0%, P < 0.001) participants than among AC (38.6%) participants. Despite substantial attrition over time, attendance at 75% of the DPP maintenance sessions was also significantly higher among IND (23.0%, P < 0.001) and GRP (26.1%, P < 0.001) participants than among AC (11.0%) participants. CONCLUSIONS: Financial incentives can improve the proportion of Medicaid beneficiaries attending the 12-month DPP and achieving at least 5% weight loss. TRIAL REGISTRATION: ClinicalTrials.gov NCT02422420 ; retrospectively registered April 21, 2015.

VarSight: prioritizing clinically reported variants with binary classification algorithms.

BACKGROUND: When applying genomic medicine to a rare disease patient, the primary goal is to identify one or more genomic variants that may explain the patient's phenotypes. Typically, this is done through annotation, filtering, and then prioritization of variants for manual curation. However, prioritization of variants in rare disease patients remains a challenging task due to the high degree of variability in phenotype presentation and molecular source of disease. Thus, methods that can identify and/or prioritize variants to be clinically reported in the presence of such variability are of critical importance. METHODS: We tested the application of classification algorithms that ingest variant annotations along with phenotype information for predicting whether a variant will ultimately be clinically reported and returned to a patient. To test the classifiers, we performed a retrospective study on variants that were clinically reported to 237 patients in the Undiagnosed Diseases Network. RESULTS: We treated the classifiers as variant prioritization systems and compared them to four variant prioritization algorithms and two single-measure controls. We showed that the trained classifiers outperformed all other tested methods with the best classifiers ranking 72% of all reported variants and 94% of reported pathogenic variants in the top 20. CONCLUSIONS: We demonstrated how freely available binary classification algorithms can be used to prioritize variants even in the presence of real-world variability. Furthermore, these classifiers outperformed all other tested methods, suggesting that they may be well suited for working with real rare disease patient datasets.

Association of platelet count with all-cause mortality and risk of cardiovascular and respiratory morbidity in stable COPD.

BACKGROUND: Platelet count is a prognostic indicator in the general population and elderly. Thrombocytosis during acute exacerbation of COPD (AECOPD) has been associated with mortality; however, the relationship between platelet count and mortality in stable COPD is unknown. METHODS: We performed post hoc secondary analysis on a subsample of 1797 patients in the Study to Understand Mortality and Morbidity in COPD (SUMMIT) who had blood samples drawn at baseline. Participants were current or former smokers, 40-80 years old with moderate COPD and history or increased risk of cardiovascular (CV) disease. The primary outcome was on and post-treatment all-cause mortality. Secondary outcomes included first-on-treatment moderate/severe AECOPD and on-treatment CV composite event (CV death, myocardial infarction, stroke, unstable angina and transient ischemic attack). Multivariable Cox proportional hazards models were used to investigate study endpoint associations with platelet count quintile grouping, continuous platelet count utilizing two-term fractional polynomials, and categories of low, normal and high platelet count (< 150, ≥150 to < 300, ≥300 × 109/L). RESULTS: Patients were followed for 2.3 ± 0.9 years for vital status and 1.6 ± 1.1 years for morbidity endpoints during which 105 (5.8%) died, 651 (36.2%) experienced AECOPD (159 with severe AECOPD) and 86 (4.8%) experienced a CV event. A U-shaped association between platelet count and all-cause mortality was observed. Compared to the third quintile group (Q3) of platelet count, risk of death was increased in the lowest quintile group (Q1; hazard ratio [HR]: 1.73; 95% confidence interval [CI]: 0.93-3.23) and highest quintile group (Q5; HR: 1.66; 95%CI: 0.89-3.10), though point estimates were imprecise. Using clinical cutoffs, compared with normal platelet counts (≥150 to < 300 × 109/L), risk of all-cause mortality was nominally increased among patients with thrombocytopenia (HR: 1.46; 95%CI: 0.81-2.64) and high platelet count (HR: 1.66; 95%CI: 0.96-2.86). Compared with Q3, CV events were nominally increased for Q5 (HR: 1.71; 95%CI: 0.83-3.49) and Q1 (HR: 1.41; 95%CI: 0.70, 2.85). There was no association between platelet count and AECOPD. CONCLUSIONS: In stable COPD platelet count demonstrated a U-shaped association with increased risk of 3-year all-cause mortality, though a platelet count level above or below which risk of mortality was increased could not be definitively identified. TRIAL REGISTRATION: ClinicalTrials.gov NCT01313676 .

Effects of thioTEPA chemotherapy on cognition and motor coordination.

Cancer survivorship has increased greatly as therapies have become more advanced and effective. Thus, we must now focus on improving the quality of life of patients after treatment. After chemotherapy, many patients experience chemotherapy-induced cognitive decline, indicating a need to investigate pathologies associated with this condition. In this study, we addressed cognitive impairment after thioTEPA treatment by assessing behavior and assaying cytokine production and the structure of dendrites in the hippocampus. Male mice were given three intraperitoneal injections of thioTEPA. Five weeks later, the mice underwent behavior testing, and brains were collected for Golgi staining and cytokine analysis. Behavior tests included y-maze and Morris water maze and licking behavioral task. Cytokines measured include: IL-1α, IL-1ß, IL-2, IL-3, IL-4, IL-5, IL-10, IL-12p70, MCP-1, TNF-α, GMCSF, and RANTES. We observed decreased memory retention in behavioral tasks. Also, dendritic arborization and length were decreased after chemotherapy treatment. Finally, thioTEPA decreased cytokine production in animals treated with chemotherapy, compared to saline-treated controls. Here, we used a mouse model to correlate the decreases in dendritic complexity and inflammatory cytokine production with cognitive impairment after chemotherapy.

Exacerbations of Chronic Obstructive Pulmonary Disease and Cardiac Events. A Post Hoc Cohort Analysis from the SUMMIT Randomized Clinical Trial.

RATIONALE: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are common, associated with acute inflammation, and may increase subsequent cardiovascular disease (CVD) risk. OBJECTIVES: Determine whether AECOPD events are associated with increased risk of subsequent CVD. METHODS: We performed a secondary cohort analysis of the SUMMIT (Study to Understand Mortality and Morbidity) trial, a convenience sample of current/former smokers with moderate COPD from 1,368 centers in 43 countries. All had CVD or increased CVD risk. AECOPD was defined as an increase in respiratory symptoms requiring treatment with antibiotics, systemic corticosteroids, and/or hospitalization. CVD events were a composite outcome of cardiovascular death, myocardial infarction, stroke, unstable angina, and transient ischemic attack. All CVD events were adjudicated. Cox proportional hazards models compared the hazard for a CVD event before AECOPD versus after AECOPD. MEASUREMENTS AND MAIN RESULTS: Among 16,485 participants in SUMMIT, 4,704 participants had at least one AECOPD and 688 had at least one CVD event. The hazard ratio (HR) for CVD events after AECOPD was increased, particularly in the first 30 days after AECOPD (HR, 3.8; 95% confidence interval, 2.7-5.5) and was elevated up to 1 year after AECOPD. The 30-day HR after hospitalized AECOPD was more than twofold greater (HR, 9.9; 95% confidence interval, 6.6-14.9). CONCLUSIONS: In patients with COPD with CVD or risk factors for CVD, exacerbations confer an increased risk of subsequent CVD events, especially in hospitalized patients and within the first 30 days after exacerbation. Patients and clinicians should have heightened vigilance for early CVD events after AECOPD. Clinical trial registered with www.clinicaltrials.gov (NCT 01313676).

Fluticasone Furoate, Vilanterol, and Lung Function Decline in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk.

RATIONALE: Many patients with chronic obstructive pulmonary disease (COPD) have an accelerated loss of lung function. It is unclear whether drug treatment can modify this in patients with moderately severe disease. OBJECTIVES: In a prespecified analysis of the key secondary outcome in SUMMIT (Study to Understand Mortality and Morbidity), we investigated whether the inhaled corticosteroid fluticasone furoate (FF; 100 µg), the long-acting ß-agonist vilanterol (VI; 25 µg), or their combination (FF/VI) modified the rate of decline in FEV1 compared with placebo. We also investigated how baseline covariates affected this decline. METHODS: Spirometry was measured every 12 weeks in this event-driven, randomized, placebo-controlled trial of 16,485 patients with moderate COPD and heightened cardiovascular risk. An average of seven spirometric assessments per subject among the 15,457 patients with at least one on-treatment measurement were used in the analysis of rate of FEV1 decline. All statistical comparisons are considered nominal. MEASUREMENTS AND MAIN RESULTS: The adjusted rates of FEV1 decline were -46 ml/yr (-3.0% of baseline) with placebo, -47 ml/yr (-3.1%) with VI, -38 ml/yr (-2.5%) with FF, and -38 ml/yr (-2.3%) with FF/VI. FF-containing regimens had lower rates of decline than placebo (P < 0.03), and FF/VI had a lower rate of decline than VI alone (P < 0.005). The FEV1 decline was faster in current smokers, those with a lower body mass index, males, and patients with established cardiovascular disease. CONCLUSIONS: In patients with moderate COPD and heightened cardiovascular risk, FF alone or in combination with VI appears to reduce the rate of FEV1 decline. Clinical trial registered with www.clinicaltrials.gov (NCT01313676).

Blood pressure, heart rate, and mortality in chronic obstructive pulmonary disease: the SUMMIT trial.

Aims: To characterize the relationship between blood pressure (BP) or heart rate and mortality and morbidity in chronic obstructive pulmonary disease (COPD). Methods and results: We performed post hoc analysis of baseline BP or heart rate and all-cause mortality and cardiovascular events in the SUMMIT trial. SUMMIT was a randomized double-blind outcome trial of 16 485 participants (65 ± 8 years, 75% male, and 47% active smokers) enrolled at 1368 sites in 43 countries. Participants with moderate COPD with or at risk for cardiovascular disease (CVD) were randomized to placebo, long-acting beta agonist, inhaled corticosteroid, or their combination. All-cause mortality increased in relation to high systolic [≥140 mmHg; hazard ratio (HR) 1.27, 95% confidence interval (CI) 1.12-1.45] or diastolic (≥90 mmHg; HR 1.35, 95% CI 1.14-1.59) BP and low systolic (<120 mmHg; HR 1.36, 95% CI 1.13-1.63) or diastolic (<80 mmHg; HR 1.15, 95% CI 1.00-1.32) BP. Higher heart rates (≥80 per minute; HR 1.39, 95% CI 1.21-1.60) and pulse pressures (≥80 mmHg; HR 1.39, 95% CI 1.07-1.80) were more linearly related to increases in all-cause mortality. The risks of cardiovascular events followed similar patterns to all-cause mortality. Similar findings were observed in subgroups of patients without established CVD. Conclusion: A 'U-shaped' relationship between BP and all-cause mortality and cardiovascular events exists in patients with COPD and heightened cardiovascular risk. A linear relationship exists between heart rate and all-cause mortality and cardiovascular events in this population. These findings extend the prognostic importance of BP to this growing group of patients and raise concerns that both high and low BP may pose health risks.

A Comparison of the Efficacy of Enema Solutions in Pediatric Emergency Department Patients.

BACKGROUND: Children presenting to pediatric emergency departments (EDs) are frequently given enemas for relief of constipation symptoms; there is very little literature guiding solution selection. OBJECTIVE: Our aim was to assess and compare the efficacy of the various enema solutions used in a pediatric ED, including the "pink lady," a previously unreported compounded combination of docusate, magnesium citrate, mineral oil, and sodium phosphate. METHODS: We identified all children who received any enema over a 5-year period in an urban, quaternary care pediatric ED for inclusion in the study via electronic record review. Physician investigators retrospectively reviewed routine visit documentation to confirm the type and dosage of enema and assess comorbidities, indications, efficacy, and side effects. Subjective descriptions of output were classified as none, small, medium, or large by reviewer consensus. RESULTS: There were 768 records included. Median age was 6.2 years (interquartile range 3.3-10.3 years). Solutions used were sodium phosphate (n = 396), pink lady (n = 198), soap suds (n = 160), and other (n = 14). There was no significant difference in output by solution type (p = 0.88). Volume delivered was highest for pink lady, with no significant association between volume delivered and output (p = 0.48). Four percent of patients had side effects. Soap suds had a significantly higher rate of side effects (10.6%; p = 0.0003), primarily abdominal pain. CONCLUSIONS: There was no significant difference in reported stool output produced by sodium phosphate, soap suds, and pink lady enemas in children treated in an ED. Further study via randomized controlled trials would be beneficial in guiding selection of enema solution.

Otherwise Healthy 15-Month-Old With Rapid-Onset Soft Tissue Swelling.

Necrotizing soft tissue infections are a serious medical emergency that involve necrosis within the soft tissue space including the dermis, subcutaneous tissue, superficial fascia, deep fascia, and muscle. Inciting factors include recent varicella infection, omphalitis, trauma, intramuscular injections, perianal trauma, and surgery. Unlike adult cases, children presenting with necrotizing soft tissue infections are more likely to be immunocompetent and without underlying chronic illnesses. Although rare in children, familiarity with the clinical manifestations of necrotizing soft tissue infections is essential for early diagnosis and surgical debridement, as significant mortality is associated with advanced disease.

Beyond what, to how: Different ways African American adolescents receive ethnic and racial socialization messages.

OBJECTIVES: Modes of transmission (MOT) of message content reveal nuances about how ethnic socialization and racial socialization occur. This study shifts the focus beyond "what" messages adolescents receive from caregivers to include "how" messages are communicated about ethnicity and race. METHOD: African American adolescents (N = 55, 72% female, Mage = 16.8) participated in semistructured interviews that were analyzed with theory-driven content analysis and quantitative procedures to derive patterns from the data. RESULTS: Various forms of verbal and nonverbal MOT were discussed by adolescents. Two patterns of associations between MOT and message content were found: Ethnic content was conveyed more often through nonverbal MOT, whereas racial content occurred more often through verbal MOT. These patterns were revealed at both the response and individual levels. CONCLUSIONS: This study links the expression aspect of MOT with ethnic and racial content in interviews that highlight teenagers' voices about how verbal and nonverbal messages about ethnicity and race are received. Further research that examines MOT in relation to message content will provide fuller awareness of ethnic and racial socialization processes. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Comparing Human Amniotic Allograft and Standard Wound Care When Using Total Contact Casting in the Treatment of Patients with Diabetic Foot Ulcers.

OBJECTIVE: This prospective, randomized study compared two treatments for diabetic foot ulcers: total contact cast and a skin substitute versus total contact cast and standard wound care. PARTICIPANTS: Researchers screened 270 adult outpatients in a Midwestern wound care clinic for inclusion. Adults 18 years or older with type 1 or 2 diabetes and a diabetic foot ulcer located on the plantar surface larger than 0.5 cm in area were invited to participate if they had not demonstrated a 50% reduction in wound area following 4 weeks of standard treatment. Thirteen patients were randomized into two intervention groups. The majority of the participants had type 2 diabetes. INTERVENTIONS: Group A treatment: total contact cast and a skin substitute (human amniotic allograft); group B treatment: total contact cast and standard wound care. OUTCOME MEASURES: Mean ulcer surface area, time to closure, recurrence rates, satisfaction with total contact casting, infection, and hemoglobin A1c were measured. RESULTS: The majority of participants experienced wound closure during the course of the study (92.3%). Two participants did not achieve closure, both of whom had Charcot foot. Group A, which had a higher mean hemoglobin A1c at study outset, experienced a longer mean time to closure (29.50 days) compared with group B (26.20 days). The 90-day recurrence rates were different for the two groups, with only one recurrence for group A (14.29%) but five recurring ulcers in group B (83.33%). CONCLUSIONS: Although significance was not established because of sample size, there was a definite trend toward significance that merits further investigation with human amniotic allograft.

The Role of Executive Function in Developmental Stuttering.

Developmental stuttering is a complex disorder and children who stutter form a heterogeneous group. Most contemporary researchers would agree that multiple factors, including those associated with linguistic, motor, sensory, and emotional processes, are likely involved in its development and/or maintenance. There is growing evidence, however, that cognitive processes also play a role. In this article, we briefly review behavioral and parent-report studies of executive function in children who stutter, the findings of which have generally suggested that these skills may be challenging for at least some children who stutter. We then consider how deficits in executive function could provide an explanatory account for not only the multifactorial nature of developmental stuttering but also the considerable amount of variability that exists among individuals who stutter.

Effect of Fluticasone Furoate and Vilanterol on Exacerbations of Chronic Obstructive Pulmonary Disease in Patients with Moderate Airflow Obstruction.

RATIONALE: Inhaled corticosteroids have been shown to decrease exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Their effects in patients with milder airflow obstruction remain unclear. OBJECTIVES: This was an analysis of exacerbations in the SUMMIT (Study to Understand Mortality and Morbidity) study. METHODS: In a double-blind, randomized controlled trial, once-daily inhaled placebo, fluticasone furoate (FF; 100 µg), vilanterol (VI; 25 µg), or the combination of FF/VI was administered. The primary outcome was all-cause mortality. Exacerbations of COPD were an additional predefined endpoint. A total of 1,368 centers in 43 countries and 16,485 patients with moderate COPD and heightened cardiovascular risk were included in the study. MEASUREMENTS AND MAIN RESULTS: Compared with placebo, FF/VI reduced the rate of moderate and/or severe exacerbations by 29% (95% confidence interval [CI], 22-35; P < 0.001) and the rate of hospitalized exacerbations by 27% (95% CI, 13-39; P < 0.001). These relative effects were similar regardless of whether subjects had a history of exacerbation in the year before the study or an FEV1 <60% or ≥60% of predicted. The number needed to treat was not influenced by baseline FEV1 but was influenced by the history of exacerbations. FF/VI also reduced the rate of exacerbations treated with corticosteroids alone or with corticosteroids and antibiotics but not the rates of those treated with antibiotics alone. CONCLUSIONS: Patients with moderate chronic airflow obstruction experienced a reduction in exacerbations with FF/VI compared with placebo, irrespective of a history of exacerbations or baseline FEV1. Clinical trial registered with www.clinicaltrials.gov (NCT 01313676; GSK Study number 113782).