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Abstract Microbial communities contribute to many essential ecological functions, from carbon cycling in soil to healthy functioning of the human body. Yet, determining how the make‐up of microbial communities is causally linked to a particular function remains a huge challenge. Despite improved tools for characterizing microbiomes at increasingly finer phylogenetic and functional scales, researchers are still unable to perform direct experimental hypothesis testing as is performed in plant and animal ecology. However, microbial ecology is not the only scientific field tasked with drawing firm causal inferences from correlational data. Here we introduce microbial ecologists to a framework used by epidemiologists: the Bradford Hill Causal Criteria. Hill posited that as a field accrues different types of evidence to support a hypothesis, it increases confidence in claiming that the hypothesized relationship is causal. A set of nine criteria help distinguish different types of evidence. Our goal was to illustrate how these causal criteria can be used in microbial ecology to retrospectively evaluate a body of research to determine the strength of a causal claim and judge the value of future research directions. We illustrate how this framework can help researchers organize their understanding of a body of literature to reveal knowledge gaps and analytical approaches that have been underutilized. We then discuss the types of causality and illustrate how investigating multicausal systems requires an updated application of older frameworks that assume one causal agent is at play for each functional outcome. We also examine analytical approaches that are appropriate for distinguishing the types of causality.

Microbial communities contribute to many essential ecological functions, from carbon cycling in soil to healthy functioning of the human body. Yet, determining how the make‐up of microbial communities is causally linked to a particular function remains a huge challenge. Despite improved tools for characterizing microbiomes at increasingly finer phylogenetic and functional scales, researchers are still unable to perform direct experimental hypothesis testing as is performed in plant and animal ecology. However, microbial ecology is not the only scientific field tasked with drawing firm causal inferences from correlational data. Here we introduce microbial ecologists to a framework used by epidemiologists: the Bradford Hill Causal Criteria. Hill posited that as a field accrues different types of evidence to support a hypothesis, it increases confidence in claiming that the hypothesized relationship is causal. A set of nine criteria help distinguish different types of evidence. Our goal was to illustrate how these causal criteria can be used in microbial ecology to retrospectively evaluate a body of research to determine the strength of a causal claim and judge the value of future research directions. We illustrate how this framework can help researchers organize their understanding of a body of literature to reveal knowledge gaps and analytical approaches that have been underutilized. We then discuss the types of causality and illustrate how investigating multicausal systems requires an updated application of older frameworks that assume one causal agent is at play for each functional outcome. We also examine analytical approaches that are appropriate for distinguishing the types of causality. [ABSTRACT FROM AUTHOR]

Aims, Design and Setting: The aim of this study was to determine which combination(s) of five e-cigarette-orientated intervention components, delivered on-line, affect smoking cessation. An on-line (UK) balanced five-factor (2 x 2 x 2 x 2 x 2 = 32 intervention combinations) randomized factorial design guided by the multi-phase optimization strategy (MOST) was used. Participants: A total of 1214 eligible participants (61% female; 97% white) were recruited via social media. Interventions: The five on-line intervention components designed to help smokers switch to exclusive e-cigarette use were: (1) tailored device selection advice; (2) tailored e-liquid nicotine strength advice; (3): tailored e-liquid flavour advice; (4) brief information on relative harms; and (5) text message (SMS) support. Measurements: The primary outcome was 4-week self-reported complete abstinence at 12 weeks post-randomization. Primary analyses were intention-to-treat (loss to follow-up recorded as smoking). Logistic regressions modelled the three- and two-way interactions and main effects, explored in that order. Findings: In the adjusted model the only significant interaction was a two-way interaction, advice on flavour combined with text message support, which increased the odds of abstinence (odds ratio = 1.55, 95% confidence interval = 1.13-2.14, P = 0.007, Bayes factor = 7.25). There were no main effects of the intervention components. Conclusions: Text-message support with tailored advice on flavour is a promising intervention combination for smokers using an e-cigarette in a quit attempt. [ABSTRACT FROM AUTHOR]

Platform trials allow efficient evaluation of multiple interventions for a specific disease. The HEALEY ALS Platform Trial is testing multiple investigational products in parallel and sequentially in persons with amyotrophic lateral sclerosis (ALS) with the goal of rapidly identifying novel treatments to slow disease progression. Platform trials have considerable operational and statistical efficiencies compared with typical randomized controlled trials due to their use of shared infrastructure and shared control data. We describe the statistical approaches required to achieve the objectives of a platform trial in the context of ALS. This includes following regulatory guidance for the disease area of interest and accounting for potential differences in outcomes of participants within the shared control (potentially due to differences in time of randomization, mode of administration, and eligibility criteria). Within the HEALEY ALS Platform Trial, the complex statistical objectives are met using a Bayesian shared parameter analysis of function and survival. This analysis serves to provide a common integrated estimate of treatment benefit, overall slowing in disease progression, as measured by function and survival while accounting for potential differences in the shared control group using Bayesian hierarchical modeling. Clinical trial simulation is used to provide a better understanding of this novel analysis method and complex design. ANN NEUROL 2023;94:547–560 [ABSTRACT FROM AUTHOR]

Background: The Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS; Tennant et al., 2007) is yet to be validated in the intellectual disability (ID) population. The aim of this study was to report the development process and assess the psychometric properties of a newly adapted version of the WEMWBS and the Short WEMWBS for individuals with mild to moderate IDs (WEMWBS‐ID/SWEMWBS‐ID). Method: The WEMWBS item wordings and response options were revised by clinicians and researchers expert in the field of ID, and a visual aid was added to the scale. The adapted version was reviewed by 10 individuals with IDs. The measure was administered by researchers online using screenshare, to individuals aged 16+ years with mild to moderate IDs. Data from three UK samples were collated to evaluate the WEMWBS‐ID (n = 96). A subsample (n = 22) completed the measure again 1 to 2 weeks later to assess test–retest reliability, and 95 participants additionally completed an adapted version of the adapted Rosenberg Self‐Esteem Scale to examine convergent validity. Additional data from a Canadian sample (n = 27) were used to evaluate the SWEMWBS‐ID (n = 123). Results: The WEMWBS‐ID demonstrated good internal consistency (ω = 0.77–0.87), excellent test–retest reliability [intraclass correlation coefficient (ICC) =.88] and good convergent validity with the self‐esteem scale (r =.48–.60) across samples. A confirmatory factor analysis for a single factor model demonstrated an adequate fit. The SWEMWBS‐ID showed poor to good internal consistency (ω = 0.36–0.74), moderate test–retest reliability (ICC =.67) and good convergent validity (r =.48–.60) across samples, and a confirmatory factor analysis indicated good model fit for a single factor structure. Conclusions: The WEMWBS‐ID and short version demonstrated promising psychometric properties, when administered virtually by a researcher. Further exploration of the scales with larger, representative samples is warranted. [ABSTRACT FROM AUTHOR]

Embracing accountability to others for one's responsibilities within relationships is important for flourishing, yet underexamined. An interdisciplinary team defined the construct of accountability and developed an 11-item single-factor Accountability Scale. In national samples with US census demographic representation (total N = 1257), we conducted psychometric analyses using methods from classical test theory (exploratory and confirmatory factor analyses) and item response theory. The Accountability Scale demonstrated internal consistency, construct validity, test-retest reliability, and incremental validity. Accountability correlated positively with relational variables (agreeableness, empathy) responsibility-oriented variables (conscientiousness, self-regulation), virtues (gratitude, forgiveness, limitations-owning humility), relational repair, perceived meaning presence, and flourishing, inversely with symptoms (personality disorders, temper, anxiety, depression), and weakly with searching for meaning and social desirability. Accountability scores superseded demographic variables, conscientiousness, and agreeableness to predict relational repair, perceived presence of meaning in life, and flourishing. We offer the accountability construct and scale to advance human flourishing research and applied work. [ABSTRACT FROM AUTHOR]

Ecological dynamics are strongly influenced by the relationship between prey density and predator feeding behavior—that is, the predatory functional response. A useful understanding of this relationship requires us to distinguish between competing models of the functional response, and to robustly estimate the model parameters. Recent advances in this topic have revealed bias in model comparison, as well as in model parameter estimation in functional response studies, mainly attributed to the quality of data. Here, we propose that an adaptive experimental design framework can mitigate these challenges. We then present the first practical demonstration of the improvements it offers over standard experimental design. Our results reveal that adaptive design can efficiently identify the preferred functional response model among the competing models, and can produce much more precise posterior distributions for the estimated functional response parameters. By increasing the efficiency of experimentation, adaptive experimental design will lead to reduced logistical burden. [ABSTRACT FROM AUTHOR]

Objective: Improving the quality of life (QoL) of older people is a key priority for governments, clinicians, researchers and service providers worldwide. However, the lack of culturally appropriate QoL tools for First Nations people is a major barrier to such efforts. The purpose of this study was to evaluate the psychometric properties of the Good Spirit, Good Life (GSGL) QoL tool for older Aboriginal Australians. Methods: One hundred and twenty older Aboriginal people living in Perth and Melbourne, Australia, were administered the GSGL tool, along with several other instruments assessing cognition (KICA‐Cog), depression (KICA‐Dep), anxiety (GAI‐SF), health and well‐being (EQ‐5D‐5L and ICECAP‐O) and resilience (ARRQ‐25). Associations between these instruments and the GSGL tool were explored to determine concurrent and known‐groups validity. Internal consistency was assessed with split‐half reliability and Cronbach's alpha. Exploratory factor analysis was performed to investigate construct validity. Results: GSGL scores were positively correlated with ICECAP‐O and ARRQ‐25 scores, and negatively correlated with EQ‐5D‐5L score. GSGL scores differed significantly between participants with a probable anxiety disorder or depression, but not those with cognitive impairment. The Spearman–Brown prophecy estimate was 0.83 and Cronbach's alpha was 0.75. Principal component analysis identified two factors, which were labelled foundation and external. Conclusions: The GSGL tool is a valid tool to assess quality of life in older Aboriginal Australians. The tool demonstrates acceptable convergent, concurrent and known‐groups validity. It was co‐designed at all stages with older Aboriginal people contributing to its strong face and content validity. [ABSTRACT FROM AUTHOR]

Objective Non-Hispanic Black birthing individuals are at increased risk of preterm birth compared to other racial and ethnic groups. In our clinical setting, we offer a tailored package of recommendations to reduce the risk of preterm birth known as an individualized prematurity prevention plan (IP3). Patient-centered, community engaged interventions that address patient-perceived barriers to preterm birth prevention are urgently needed. Materials and methods We engaged a group of stakeholders to develop a mutli-level (patient-centered and community-involved) intervention that will increase adherence to an individualized prematurity prevention plan (IP3) by addressing barriers identified during our prior qualitative studies. Results The intervention includes trained doulas from a community-led, Black owned doula group. The doulas will moderate group prenatal social support sessions. In between the group sessions, participants will be encouraged to continue interacting with one another and the doulas using a private Facebook™ group page. We will pilot test the intervention in a cohort of pregnant, self-identified non-Hispanic Black patients with a history of prior preterm birth. Conclusion We present a novel, patient-centered, community engaged intervention to reduce preterm birth in high-risk non-Hispanic Black birthing individuals. If the intervention is feasible based on the pilot study findings, we anticipate conducting an appropriately powered study to determine whether the intervention achieves our goal of reducing preterm birth. [ABSTRACT FROM AUTHOR]

The antidiabetic medication metformin has been proposed to be the first drug tested to target aging and extend healthspan in humans. While there is extensive epidemiological support for the health benefits of metformin in patient populations, it is not clear if these protective effects apply to those free of age-related disease. Our previous data in older adults without diabetes suggest a dichotomous change in insulin sensitivity and skeletal muscle mitochondrial adaptations after metformin treatment when co-prescribed with exercise. Those who entered the study as insulin-sensitive had no change to detrimental effects while those who were insulin-resistant had positive changes. The objective of this clinical trial is to determine if (a) antecedent metabolic health and (b) skeletal muscle mitochondrial remodeling and function mediate the positive or detrimental effects of metformin monotherapy, independent of exercise, on the metabolism and biology of aging. In a randomized, double-blind clinical trial, adults free of chronic disease (n = 148, 40–75 years old) are stratified as either insulin-sensitive or resistant based on homeostatic model assessment of insulin resistance (≤2.2 or ≥2.5) and take 1 500 mg/day of metformin or placebo for 12 weeks. Hyperinsulinemic-euglycemic clamps and skeletal muscle biopsies are performed before and after 12 weeks to assess primary outcomes of peripheral insulin sensitivity and mitochondrial remodeling and function. Findings from this trial will identify clinical characteristics and cellular mechanisms involved in modulating the effectiveness of metformin treatment to target aging that could inform larger Phase 3 clinical trials aimed at testing aging as a treatment indication for metformin. Clinical Trials Registration Number : NCT04264897. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has led to radical disruptions to the routines of individuals and families, but there are few psychometrically assessed measures for indexing behavioural responses associated with a modern pandemic. Given the likelihood of future pandemics, valid tools for assessing pandemic-related behavioral responses relevant to mental health are needed. This need may be especially salient for studies involving families, as they may experience higher levels of stress and maladjustment related to school and business closures. We therefore created the Pandemic Avoidance and Concern Scales (PACS) to assess caregivers' and youths' adjustment to COVID-19 and future pandemics. Concern and Avoidance factors derived from exploratory factor analyses were associated with measures of internalizing symptoms, as well as other indices of pandemic-related disruption. Findings suggest that the PACS is a valid tool for assessing pandemic-related beliefs and behaviors in adults and adolescents. Preliminary findings related to differential adjustment between caregivers and youths are discussed. [ABSTRACT FROM AUTHOR]

The Interpersonal Psychological Theory of Suicide has a growing base of empirical support for use with adolescents. Of the two interpersonal constructs that make up the theory, perceived burdensomeness demonstrates a stronger relationship with suicidal ideation and appears more resistant to change over the course of treatment than thwarted belongingness. Despite this, there are few clinical interventions directly informed by theoretical models of suicide. Qualitative methodology is currently underutilized in better understanding the manifestation of theoretical constructs among suicidal youth and may shed light on how to harness this information during intervention development. Qualitative interviews about perceived burdensomeness were conducted with adolescents with a history of suicidality (n = 10), their parents (n = 10), and clinicians administering care to this population (n = 10). Perceived burdensomeness was widely recognized and described as relevant by all participants. Parents and clinicians expressed limited success when trying to directly address these cognitions with adolescents. Results from this exploratory study elucidated a close relationship with thwarted belongingness, especially in regard to how burden cognitions can lead to behaviors that damage social connectedness. An enhanced clinical model of perceived burdensomeness is proposed that identifies possible mechanisms of change when targeting this construct in a clinical setting. Potential interventions informed by these results are also outlined. Highlights: Cognitions of burdensomeness cause levels of thwarted belongingness to rise. Qualitative methods allow for a deeper understanding of theories of suicide. Interventions targeting cognitions of burdensomeness among youth are needed. [ABSTRACT FROM AUTHOR]

Memories are encoded in a manner that depends on our knowledge and expectations ("schemas"). Consistent with this, expertise tends to improve memory: Experts have elaborated schemas in their domains of expertise, allowing them to efficiently represent information in this domain (e.g., chess experts have enhanced memory for realistic chess layouts). On the other hand, in most situations, people tend to remember abnormal or surprising items best—those that are also rare or out-of-the-ordinary occurrences (e.g., surprising—but not random—chess board configurations). This occurs, in part, because such images are distinctive relative to other images. In the current work, we ask how these factors interact in a particularly interesting case—the domain of radiology, where experts actively search for abnormalities. Abnormality in mammograms is typically focal but can be perceived in the global "gist" of the image. We ask whether, relative to novices, expert radiologists show improved memory for mammograms. We also test for any additional advantage for abnormal mammograms that can be thought of as unexpected or rare stimuli in screening. We find that experts have enhanced memory for focally abnormal images relative to normal images. However, radiologists showed no memory benefit for images of the breast that were not focally abnormal, but were only abnormal in their gist. Our results speak to the role of schemas and abnormality in expertise; the necessity for spatially localized abnormalities versus abnormalities in the gist in enhancing memory; and the nature of memory and decision-making in radiologists. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the study was to develop and validate a probe word list and scoring system to assess speech motor skills in preschool and school-age children with motor speech disorders. Method: This article describes the development of a probe word list and scoring system using a modified word complexity measure and principles based on the hierarchical development of speech motor control known as the Motor Speech Hierarchy (MSH). The probe word list development accounted for factors related to word (i.e., motoric) complexity, linguistic variables, and content familiarity. The probe word list and scoring system was administered to 48 preschool and school-age children with moderate-to-severe speech motor delay at clinical centers in Ontario, Canada, and then evaluated for reliability and validity. Results: One-way analyses of variance revealed that the motor complexity of the probe words increased significantly for each MSH stage, while no significant differences in the linguistic complexity were found for neighborhood density, mean biphone frequency, or log word frequency. The probe word list and scoring system yielded high reliability on measures of internal consistency and intrarater reliability. Interrater reliability indicated moderate agreement across the MSH stages, with the exception of MSH Stage V, which yielded substantial agreement. The probe word list and scoring system demonstrated high content, construct (unidimensionality, convergent validity, and discriminant validity), and criterion-related (concurrent and predictive) validity. Conclusions: The probe word list and scoring system described in the current study provide a standardized method that speech-language pathologists can use in the assessment of speech motor control. It can support clinicians in identifying speech motor difficulties in preschool and school-age children, set appropriate goals, and potentially measure changes in these goals across time and/or after intervention. [ABSTRACT FROM AUTHOR]

Background: The aim of the study was to describe a novel technique for reinforcement of salvage laryngectomy closure using a bipedicled musculofascial submental flap. Methods: A retrospective cohort study design identified patients who underwent salvage laryngectomy reinforcement with a bipedicled submental hammock flap between January 2008 and December 2016 were compared to salvage laryngectomy patients treated with primary closure of the neopharynx during the same time period. Pharyngocutaneous fistula rates were compared between groups. Results: Pharyngocutaneous fistula rate in the submental hammock group (2/31, 6.5%) was significantly lower compared to the primary closure group (14/45, 31%, P <.05). Conclusion: The bipedicled musculofascial submental hammock flap is a viable method for reinforcement of salvage laryngectomy defects. It has a favorable pharyngocutaneous fistula rate compared to primary closure alone and has unique advantages over conventional methods of reinforcement. [ABSTRACT FROM AUTHOR]

BACKGROUND: Despite the substantial role indoor exposure has played in heat wave–related mortality, few epidemiological studies have examined the health effects of exposure to indoor heat. As a result, knowledge gaps regarding indoor heat–health thresholds, vulnerability, and adaptive capacity persist. OBJECTIVE: We evaluated the role of indoor heat exposure on mortality and morbidity among the elderly (=65 years of age) in Houston, Texas. METHODS: Mortality and emergency hospital admission data were obtained through the Texas Department of State Health Services. Summer indoor heat exposure was modeled at the U.S. Census block group (CBG) level using building energy models, outdoor weather data, and building characteristic data. Indoor heat–health associations were examined using time-stratified case-crossover models, controlling for temporal trends and meteorology, and matching on CBG of residence, year, month, and weekday of the adverse health event. Separate models were fitted for three indoor exposure metrics, for individual lag days 0–6, and for 3-d moving averages (lag 0–2). Effect measure modification was explored via stratification on individual- and area-level vulnerability factors. RESULTS: We estimated positive associations between short-term changes in indoor heat exposure and cause-specific mortality and morbidity [e.g., circulatory deaths, odds ratio per 5° C increase = 1:16 (95% CI: 1.03, 1.30)]. Associations were generally positive for earlier lag periods and weaker across later lag periods. Stratified analyses suggest stronger associations between indoor heat and emergency hospital admissions among African Americans compared with Whites. DISCUSSION: Findings suggest excess mortality among certain elderly populations in Houston who are likely exposed to high indoor heat. We developed a novel methodology to estimate indoor heat exposure that can be adapted to other U.S. locations. In locations with high air conditioning prevalence, simplified modeling approaches may adequately account for indoor heat exposure in vulnerable neighborhoods. Accounting for indoor heat exposure may improve the estimation of the total impact of heat on health. [ABSTRACT FROM AUTHOR]

Background and purpose — Compressive osseointegration fixation is an alternative to intramedullary fixation for endoprosthetic reconstruction. Mechanical failure of compressive osseointegration presents differently on radiographs than stemmed implants, therefore we aimed to develop a reliable radiographic method to determine stable integration. Patients and methods — 8 reviewers evaluated 11 radiographic parameters from 29 patients twice, 2 months apart. Interclass correlation coefficients (ICCs) were used to assess test–retest and inter-rater reliability. We constructed a fast and frugal decision tree using radiographic parameters with substantial test–retest agreement, and then tested using radiographs from a new cohort of 49 patients. The model's predictions were compared with clinical outcomes and a confusion matrix was generated. Results — 6 of 8 reviewers had non-significant intra-rater ICCs for ≥ one parameter; all inter-rater ICCs were highly reliable (p < 0.001). Change in length between the top of the spindle sleeve and bottom of the anchor plug (ICC 0.98), bone cortex hypertrophy (ICC 0.86), and bone pin hypertrophy (ICC 0.81) were used to create the decision tree. The sensitivity and specificity of the training cohort were 100% (95% CI 52–100) and 87% (CI 74–94) respectively. The decision tree demonstrated 100% (CI 40–100) sensitivity and 89% (CI 75–96) specificity with the test cohort. Interpretation — A stable spindle length and at least 3 cortices with bone hypertrophy at the implant interface predicts stable osseointegration; failure is predicted in the absence of bone hypertrophy at the implant interface if the pin sites show hypertrophy. Thus, our decision tree can guide clinicians as they follow patients with compressive osseo-integration implants. [ABSTRACT FROM AUTHOR]

The full-length Schedule for Nonadaptive and Adaptive Personality - 2nd Edition (SNAP-2, Clark et al. 2014) and various derivative versions were developed as measures of normal- and pathological-range personality traits. We report herein on the development and initial validation of the SNAP Brief Other-Description Rating Form (SNAP-BORF), an abbreviated version of the SNAP Other-Description Rating Form (ORF; Harlan and Clark Assessment, 6, 131–145, 1999). Our goal was to create a more efficient SNAP informant short form by making items more succinct rather than by eliminating items. SNAP-ORF word count was reduced by 68%, and the 1.5-page SNAP-BORF can be completed in approximately 10 min, one-third to one-half the time required to complete the SNAP-ORF. Mean-level differences between the SNAP-ORF and SNAP-BORF scales were negligible for all scales except propriety. Using exploratory factor analysis, we found the SNAP-BORF had a three-factor structure (NA vs. Low PA, Disinhibition vs. Constraint, and Antagonism) broadly consistent with extant literature. The SNAP-BORF showed good convergent/ discriminant validity with respect to the SNAP-family measures as well as measures of normal personality and symptoms of depression, anxiety, and worry. Results indicated that the SNAP-BORF is a useful measure when a very brief informant assessment of adaptive and maladaptive personality is needed. [ABSTRACT FROM AUTHOR]

Background: Cellulitis is a painful, potentially serious, infectious process of the dermal and subdermal tissues and represents a significant disease burden. The statistical analysis plan (SAP) for the Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial is described here. The PEDOCELL trial is a multicentre, randomised, parallel-arm, double-blinded, non-inferiority clinical trial comparing the efficacy of flucloxacillin (monotherapy) with combination flucloxacillin/phenoxymethylpenicillin (dual therapy) for the outpatient treatment of cellulitis in the emergency department (ED) setting. To prevent outcome reporting bias, selective reporting and data-driven results, the a priori-defined, detailed SAP is presented here.Methods/design: Patients will be randomised to either orally administered flucloxacillin 500 mg four times daily and placebo or orally administered 500 mg of flucloxacillin four times daily and phenoxymethylpenicillin 500 mg four times daily. The trial consists of a 7-day intervention period and a 2-week follow-up period. Study measurements will be taken at four specific time points: at patient enrolment, day 2-3 after enrolment and commencing treatment (early clinical response (ECR) visit), day 8-10 after enrolment (end-of-treatment (EOT) visit) and day 14-21 after enrolment (test-of-cure (TOC) visit). The primary outcome measure is investigator-determined clinical response measured at the TOC visit. The secondary outcomes are as follows: lesion size at ECR, clinical treatment failure at each follow-up visit, adherence and persistence of trial patients with orally administered antibiotic therapy at EOT, health-related quality of life (HRQoL) and pharmacoeconomic assessments. The plan for the presentation and comparison of baseline characteristics and outcomes is described in this paper.Discussion: This trial aims to establish the non-inferiority of orally administered flucloxacillin monotherapy with orally administered flucloxacillin/phenoxymethylpenicillin dual therapy for the ED-directed outpatient treatment of cellulitis. In doing so, this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines. The SAP for the PEDOCELL trial was developed a priori in order to minimise analysis bias.Trial Registration: EU Clinical Trials Register (EudraCT number: 2016-001528-69). Registered on 5 April 2016. ClinicalTrials.gov, ID: NCT02922686 . Registered on 9 August 2016. [ABSTRACT FROM AUTHOR]

The article focuses on experimental therapies that are used in the treatment of Ebola virus disease (EVD). Various topics discussed include mortality rate of EVD, supportive care offered to patients suffering from EVD, child's survival through these therapies and use of antiviral agents in the treatment.

Background: Contrary to intuition, use of lower strength nicotine e-liquids might not offer reduced health risk if compensatory puffing behaviour occurs. Compensatory puffing (e.g. more frequent, longer puffs) or user behaviour (increasing the wattage) can lead to higher temperatures at which glycerine and propylene glycol (solvents used in e-liquids) undergo decomposition to carbonyl compounds, including the carcinogens formaldehyde and acetaldehyde. This study aims to document puffing patterns and user behaviour associated with using high and low strength nicotine e-liquid and associated toxicant/carcinogen exposure in experienced e-cigarette users (known as vapers herein).Methods/design: A counterbalanced repeated measures design.Participants: Non-tobacco smoking vapers; have used an e-cigarette for ≥3 months; currently using nicotine strength e-liquid ≥12mg/mL and a second or third generation device.Intervention: This study will measure puffing patterns in vapers whilst they use high and low strength nicotine e-liquid under fixed and user-defined settings, each for a week. The 4 counterbalanced conditions are: i) low strength (6mg/mL), fixed settings; ii) low strength user-defined settings; iii) high strength (18mg/mL) fixed settings; iv) high strength user-defined settings. Biomarkers of exposure to toxicants and carcinogens will be measured in urine. In the second phase of this study, toxicant yields will be measured in aerosol generated using a smoking machine operated to replicate the puffing behaviours of each participant.Primary Outcomes: i) Puffing patterns (mean puff number, puff duration, inter-puff interval and mL of liquid consumed) and user behaviour (changes to device settings: voltage and air-flow) associated with using high and low strength nicotine e-liquid. ii) Toxicant/carcinogen exposure associated with the puffing patterns/device settings used by our participants.Secondary Outcomes: i) Subjective effects. ii) comparisons with toxicant exposure from tobacco smoke (using documented evidence) and with recommended safety limits.Sample Size: Twenty participants.Discussion: The findings will have important implications for public health messaging regarding the relative risks and subjective effects associated with using high and low strength nicotine e-liquid, and for policy makers regarding regulations on nicotine concentrations in e-liquids. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to examine the time course of health, fitness, and occupational performance changes in firefighter recruits across a fire academy. Methods: Nineteen recruits (24.9 ± 4.3 yr; 26.7 ± 3.1 kg·m−2) had their body composition, balance, vertical jump (VJ) performance, cardiorespiratory fitness (CRF), upper and lower body strength, hamstrings-to-quadriceps (H/Q) ratio, lower back endurance, and weighted stair climb (SC) performance assessed at the beginning (week 1 [W1]), midpoint (week 15 [W15]), and end (week 30 [W30]) of a fire academy. Results: The fire academy improved body composition, balance, CRF, leg extension strength, and SC performance from W1 to W15 (P ≤ 0.042) which then plateaued at W30 (P ≥ 0.314). Leg flexion strength and the H/Q ratio decreased from W1 to W15 (P ≤ 0.035) and plateaued at W30 (P ≥ 0.947). Upper body strength was similar at W1 and W15 (P ≥ 0.999), but decreased at W30 (P ≤ 0.033). However, no significant changes occurred across the academy for VJ performance or lower back endurance (P ≥ 0.090). Conclusions: These findings highlight the positive effect of the academy on body composition, CRF, balance, SC performance, and leg extension strength. However, the decreases in upper body and leg flexion strength, the H/Q ratio, and lack of changes in VJ performance and low back endurance may highlight key areas of need to maximize injury prevention and performance enhancement efforts in the academy. Further, the varied time course of changes may help fire departments identify opportunities to modify exercise programming across their academies. [ABSTRACT FROM AUTHOR]

This research examines the effects of thinking styles (holistic vs. analytic) and different levels of information congruity on product evaluations. Two experimental studies show that presenting more details in a message matches the analytic thinking style, thus leading to higher evaluations of extremely incongruent information, from analytic thinkers and lower evaluations from holistic thinkers. [ABSTRACT FROM AUTHOR]

The Schedule for Nonadaptive and Adaptive Personality full-length (SNAP) and short versions (SNAP-SRF and SNAP-ORF) were developed as measures of normal-range and more pathological personality traits. This study investigated the validity of the SNAP Brief Self-Description Rating Form (SNAP-BSRF), an alternative version of the SNAP Self-Description Rating Form (SNAP-SRF) revised for further brevity. The scales of the SNAP-BSRF showed good convergence with the SNAP-SRF and the SNAP Other-Description Rating Form (SNAP-ORF) scales. A three-factor structure consistent with extant literature was found for the SNAP-BSRF using an exploratory structural equation modeling approach. Scales from the SNAP-BSRF showed meaningful associations with self-reported internalizing symptoms. Results suggest that this new version is a reasonable substitute for the SNAP-SRF and will be useful when a very brief measure of adaptive and maladaptive personality is needed. [ABSTRACT FROM PUBLISHER]

In developing recommendations for core measures/items for the evaluation of the Youth Expanded Food and Nutrition Education Program (EFNEP), three nutrition education curricula, implemented by land grant universities, were content analyzed. Selection criteria included the following: Curriculum content must include all EFNEP core content areas and must be implemented in more than one state with school children in third through fifth grades. Content analysis strategies were employed to identify and describe common areas/themes and mediators of behaviors addressed across the selected curricula. Content analysis coding was based on a list of behavioral mediators, which have empirical associations with nutrition, physical activity, and food safety. The most evident approaches identified across the three curricula were to enhance motivation, teach cognitive knowledge, and practice behavioral skills. The presence of self-regulation and environmental theory–based strategies was limited in all three curricula. In addition, multiple themes for nutrition, physical activity, and food safety were commonly addressed across curricula with multiple educational strategies. Based on these findings, recommendations for developing content appropriate measures and items for an outcome evaluation tool for Youth EFNEP are provided. [ABSTRACT FROM PUBLISHER]

Previous work has identified 6 important areas to consider when evaluating validity and bias in studies of prognostic factors: participation, attrition, prognostic factor measurement, confounding measurement and account, outcome measurement, and analysis and reporting. This article describes the Quality In Prognosis Studies tool, which includes questions related to these areas that can inform judgments of risk of bias in prognostic research.A working group comprising epidemiologists, statisticians, and clinicians developed the tool as they considered prognosis studies of low back pain. Forty-three groups reviewing studies addressing prognosis in other topic areas used the tool and provided feedback. Most reviewers (74%) reported that reaching consensus on judgments was easy. Median completion time per study was 20 minutes; interrater agreement (κ statistic) reported by 9 review teams varied from 0.56 to 0.82 (median, 0.75). Some reviewers reported challenges making judgments across prompting items, which were addressed by providing comprehensive guidance and examples. The refined Quality In Prognosis Studies tool may be useful to assess the risk of bias in studies of prognostic factors. [ABSTRACT FROM AUTHOR]

Adults' processing of own-race faces differs from that of other-race faces. The presence of an 'other-race' feature (ORF) has been proposed as a mechanism underlying this specialization. We examined whether this mechanism, which was previously identified in adults and in 9-month-olds, is evident at 3.5 months. Caucasian 3.5-month-olds looked longer at a pattern containing a single Asian face among seven Caucasian faces than at a pattern containing a single Caucasian face among seven Asian faces. Homogenous and inverted face control conditions indicated that infants' preference was not driven by the majority of faces in arrays or by low-level features. Thus, 3.5-month-olds found the presence of an other-race face among own-race faces to be more salient than the reverse configuration. This asymmetry suggests sensitivity to an ORF at 3.5 months. Thus, a key mechanism of race-based processing in adults has an early onset, indicating rapid development of specialization early in life. [ABSTRACT FROM AUTHOR]

Like faces, bodies are significant sources of social information. However, research suggests that infants do not develop body representation (i.e., knowledge about typical human bodies) until the second year of life, although they are sensitive to facial information much earlier. Yet, previous research only examined whether infants are sensitive to the typical arrangement of body parts. We examined whether younger infants have body knowledge of a different kind, namely the relative size of body parts. Five- and 9-month-old infants were tested for their preference between a normal versus a proportionally distorted body. Nine-month-olds exhibited a preference for the normal body when images were presented upright but not when they were inverted. Five-month-olds failed to exhibit a preference in either condition. These results indicate that infants have knowledge about human bodies by the second half of the first year of life. Moreover, given that better performance on upright than on inverted stimuli has been tied to expertise, the fact that older infants exhibited an inversion effect with body images indicates that at least some level of expertise in body processing develops by 9 months of age. [ABSTRACT FROM AUTHOR]

Microwave characterization of an integrated inductor is often carried out with respect to a local ground reference. The measurement outcome, however, does not necessarily reproduce the behavior of the device in an actual circuit where a ground reference does not exist. Furthermore, inductor measurements can be affected by the unequal currents on the inner and outer conductors of the coaxial lines internal to the RF probes. Such currents tend to radiate the microwave energy into the surroundings and manifest themselves as unexpected ripple and resonance features in measurement results. In this study, a measurement model is developed including both effects and is used to analyze experimental data obtained from integrated spiral inductors. A novel deembedding technique is then proposed and applied to eliminate the local ground and unequal coaxial current effects. [ABSTRACT FROM AUTHOR]

Purpose: To review the concepts of reliability and validity, provide examples of how the concepts have been used in nursing research, provide guidance for improving the psychometric soundness of instruments, and report suggestions from editors of nursing journals for incorporating psychometric data into manuscripts. Methods: CINAHL, MEDLINE, and PsycINFO databases were searched using key words: validity, reliability, and psychometrics. Nursing research articles were eligible for inclusion if they were published in the last 5 years, quantitative methods were used, and statistical evidence of psychometric properties were reported. Reports of strong psychometric properties of instruments were identified as well as those with little supporting evidence of psychometric soundness. Findings: Reports frequently indicated content validity but sometimes the studies had fewer than five experts for review. Criterion validity was rarely reported and errors in the measurement of the criterion were identified. Construct validity remains underreported. Most reports indicated internal consistency reliability (α) but few reports included reliability testing for stability. When retest reliability was asserted, time intervals and correlations were frequently not included. Conclusions: Planning for psychometric testing through design and reducing nonrandom error in measurement will add to the reliability and validity of instruments and increase the strength of study findings. Underreporting of validity might occur because of small sample size, poor design, or lack of resources. Lack of information on psychometric properties and misapplication of psychometric testing is common in the literature. [ABSTRACT FROM AUTHOR]

The article focuses on the research design and preliminary results of the Vrokastro survey project from 1986 to 1989 in Vrokastro Site, Greece. According to the researchers, the aim of the survey project is to place the settlement within a regional context to understand its function and related to its environment. The preliminary results of the survey show that the primarily rural or intermediate nature of the region during most periods was a border area crossed by routes between more celebrated places.

Abstract: Objective: Systematic reviews of prognostic factors for low back pain vary substantially in design and conduct. The objective of this study was to identify, describe, and synthesize systematic reviews of low back pain prognosis, and explore the potential impact of review methods on the conclusions. Study Design and Setting: We identified 17 low back pain prognosis reviews published between 2000 and 2006. One reviewer extracted and a second checked review characteristics and results. Two reviewers independently assessed review quality. Results: Review questions and selection criteria varied; there were both focused and broad reviews of prognostic factors. A quarter of reviews did not clearly define search strategies. The number of potential citations identified ranged from 15 to 4,458 and the number of included prognosis studies ranged from 3 to 32 (of 162 distinct citations included across reviews). Seventy percent of reviews assessed quality of included studies, but assessed only a median of four of six potential biases. All reviews reported associations based on statistical significance; they used various strategies for syntheses. Only a small number of important prognostic factors were consistently reported: older age, poor general health, increased psychological or psychosocial stress, poor relations with colleagues, physically heavy work, worse baseline functional disability, sciatica, and the presence of compensation. We found discrepancies across reviews: differences in some selection criteria influenced studies included, and various approaches to data interpretation influenced review conclusions about evidence for specific prognostic factors. Conclusion: There is an immediate need for methodological work in the area of prognosis systematic reviews. Because of methodological shortcomings in the primary and review literature, there remains uncertainty about reliability of conclusions regarding prognostic factors for low back pain. [Copyright &y& Elsevier]

Abstract: Experimental results on the wake properties of a non-rotating simplified wind turbine model, based on the actuator disc concept, and a rotating model, a three-blade wind turbine, are presented. Tests were performed in two different test sections, one providing a nominally decaying isotropic turbulent inflow (turbulence intensity of 4% at rotor disc location) and one providing a neutral atmospheric boundary layer above a moderately rough terrain at a geometric scale of 1:300 (determined from the combination of several indicators), with 13% of turbulence intensity at hub height. The objective is to determine the limits of the simplified wind turbine model to reproduce a realistic wind turbine wake. Pressure and high-order velocity statistics are therefore compared in the wake of both rotor discs for two different inflow conditions in order to quantify the influence of the ambient turbulence. It has been shown that wakes of rotating model and porous disc developing in the modeled atmospheric boundary layer are indistinguishable after 3 rotor diameters downstream of the rotor discs, whereas few discrepancies are still visible at the same distance with the decaying isotropic turbulent inflow. [Copyright &y& Elsevier]

Abstract: Only a small fraction of drug users worldwide enter treatment each year. We evaluated the efficacy of a systemic family outreach intervention (SFOI) for young, untreated drug users, using a quasi-experimental design in which the experimental group (EG) received SFOI and the control group (CG) received traditional outreach work (OW). Both pre- and post-treatment, we administered the Addiction Severity Index–6 (ASI-6), the Family Environment Scale (FES), and tests of parental practices and risky behavior. Post-treatment, there was a fivefold improvement on the ASI-6 and a significant worsening on the conflict sub-scale of the FES in the EG as compared with the CG. SFOI was more efficacious than OW in reducing drug use in the drug user''s home environment. The increased conflict in the EG might be explained by parents'' increased awareness of abnormal behaviors and implementation of strategies to protect their children. [Copyright &y& Elsevier]

Abstract: Intense ultra-short XUV-pulses from the Free Electron Laser in Hamburg (FLASH) were used in combination with the synchronized near-infrared (NIR) radiation from a femtosecond laser to perform two-color experiments on rare gas atoms and small molecules. Results of atomic photoionization in the presence of a NIR dressing field are presented and discussed for the low field regime, i.e. for intensities of less than 1011 W/cm2. In particular, the analysis of two-color Above Threshold Ionization (ATI) as a function of the relative orientation of the polarization vectors of both photon beams provided detailed information about the partial photoionization crosssections by comparing the experimental results with theoretical values obtained by employing second-order perturbation theory and the “soft-photon” approximation. Furthermore, a first time-resolved study was performed on the photodissociation of molecular hydrogen. In this proof-of-principle experiment, the excited atomic fragments, produced in the primary interaction with the intense XUV pulse, are probed by a time delayed NIR laser pulse that ionizes these fragments. [ABSTRACT FROM AUTHOR]