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Background: Behavioural intention (BI) has been predicted using other variables by adopting the technology acceptance model (TAM). However, few studies have examined whether BI can predict learning performance. Objectives: The present study used an extended TAM to investigate whether students' BI is a predictor of their listening learning performance (LLP) through vocabulary learning performance (VLP) in the context of mobile vocabulary‐assisted listening learning by using two mobile learning tools. Methods: A total of 129 college students with a pre‐intermediate level of English were recruited as participants, and a 10‐week mobile vocabulary‐assisted, listening‐learning course was conducted in 2022. In each task of this course, the students had to learn target words from a listening passage on Quizlet and then engage in listening activities on Randall's ESL Cyber Listening Lab. Quantitative responses obtained through an online questionnaire were analysed through partial‐least‐squares structural equation modelling. Results: The analysis results indicated that BI significantly predicted LLP through VLP. Perceived ease of use (PEU) and perceived usefulness (PU) were significant antecedents of BI. However, PEU did not significantly predict PU because of the difficulty of navigating between the two technological tools used in this study. The extended model demonstrated its effectiveness in explaining listening learning performance, as evidenced by an explained variance (R2) of 69%. Conclusion: The extended model validates the influence of BI on learning performance and it can also draw teachers' focus toward the significance of enhancing students' BI to improve their listening learning performance. Pedagogical implications based on the results are provided in this paper. Lay Description: What is already known about this topic?: TAM was used to study learners' acceptance of mobile‐assisted language learning.TAM incorporates latent variables to explore mobile‐assisted language learning.Investigating factors influencing BI is a primary research focus in extended TAM literature.Mobile tools could improve listening learning and vocabulary retention. What this paper adds to that: Learning performance was considered as a dependent variable in an extended TAM.BI might predict students' learning performance in vocabulary and listening in an extended TAM.Teachers used two mobile tools to design mobile vocabulary‐assisted listening tasks.Pre‐learning the target words facilitate students' listening learning performance. Implications for practice and/or policy: We show the importance of BI on predicting listening learning performance.The impact of BI on other factors became another focus of TAM research.Results highlight pre‐learning target words' importance for better listening performance.Existing mobile tools improve listening performance, avoiding new system development. [ABSTRACT FROM AUTHOR]

Objectives: DETERMIND (DETERMinants of quality of life, care and costs, and consequences of INequalities in people with Dementia and their carers) is designed to address fundamental, and, as yet unanswered questions about inequalities, outcomes and costs following diagnosis with dementia. These answers are needed to improve the quality of care and equity of access to care, and therefore the quality of life, of people with dementia and their carers.Method: DETERMIND is a programme of research consisting of seven complementary workstreams (WS) exploring various components that may result in unequal dementia care: WS1: Recruitment and follow-up of the DETERMIND cohort-900 people with dementia and their carers from three geographically and socially diverse sites within six months following diagnosis, and follow them up for three years. WS2: Investigation of the extent of inequalities in access to dementia care. WS3: Relationship between use and costs of services and outcomes. WS4: Experiences of self-funders of care. WS5: Decision-making processes for people with dementia and carers. WS6: Effect of diagnostic stage and services on outcomes. WS7: Theory of Change informed strategy and actions for applying the research findings.Outcomes: During the life of the programme, analysing baseline results and then follow-up of the DETERMIND cohort over 3 years, we will establish evidence on current services and practice. DETERMIND will deliver novel, detailed data on inequalities in dementia care and what drives positive and negative outcomes and costs for people with dementia and carers, and identify factors that help or hinder living well with dementia. [ABSTRACT FROM AUTHOR]

Mobile devices are increasingly used to administer self-report measures of mental health symptoms. There are significant differences, however, in the way that information is presented on mobile devices compared to the traditional paper forms that were used to administer such measures. Such differences may systematically alter responses. The present study evaluated if and how responses differed for a self-report measure, the PTSD Checklist (PCL), administered via mobile device relative to paper and pencil. Participants were 153 trauma-exposed individuals who completed counterbalanced administrations of the PCL on a mobile device and on paper. PCL total scores (d = 0.07) and item responses did not meaningfully or significantly differ across administrations. Power was sufficient to detect a difference in total score between administrations determined by prior work of 3.46 with a d = 0.23. The magnitude of differences between administration formats was unrelated to prior use of mobile devices or participant age. These findings suggest that responses to self-report measures administered via mobile device are equivalent to those obtained via paper and they can be used with experienced as well as naïve users of mobile devices. [ABSTRACT FROM AUTHOR]

Introduction: Involving service users in health service design and delivery is considered important to improve the quality of healthcare because it ensures that the delivery of healthcare is adapted to the needs of the users. Co‐production is a process used to involve service users, but multiple papers have highlighted the need for the mechanisms and values guiding co‐production to be more clearly stated. The aim of this paper was to evaluate the mechanisms and values that guided the co‐production approach of the Stories for Change project, which used Public Narrative as part of the co‐design process to create change in National Health Service maternity services. Methods: This study was conducted using a rapid feedback evaluation approach. Semistructured interviews (n = 16) were the main source of data, six of which were maternity service users, with observations (5 h) and documentary analysis also carried out in parallel. RREAL sheets were used for data analysis to organize data based on key topics of interest. Results: This study identified three broad mechanisms and values underpinning the co‐production approach: creating an open and safe space to share ideas, learning how to tell stories using Public Narrative and having service providers who play a key role in strengthening the health system listen to stories compelling them to action. This study identified the main areas for improvement of the Stories for Change project related to recruitment, the inclusion of participants, the co‐design process, the Skills Session and the Learning Event. Conclusion: Our study provided a deeper understanding of the co‐production approach that addresses the need to uncover the mechanism and values underlying co‐production and co‐design approaches. This study expands on the literature pertaining to the influence of storytelling in creating meaningful change in health care. We propose a co‐design methodology that uses Public Narrative as a model for service user engagement to help inform future healthcare development processes. Patient or Public Contribution: The experiences and perceptions of maternity service users and health professionals informed this evaluation. The project organizers were involved in the manuscript preparation stage by providing feedback, and service users wrote a commentary on the project from the lived experience perspective. [ABSTRACT FROM AUTHOR]

Most Human African Trypanosomiasis (HAT) control programmes in areas endemic for Trypanosoma brucei gambiense rely on a strategy of active mass screening with the Card Agglutination Test for Trypanosomiasis (CATT)/T. b. gambiense. We evaluated the performance, stability and reproducibility of the CATT/T. b. gambiense on blood-impregnated filter papers (CATT-FP) in Kajo-Keji County, South-Sudan, where some areas are inaccessible to mobile teams. The CATT-FP was performed with a group of 100 people with a positive CATT on whole blood including 17 confirmed HAT patients and the results were compared with the CATT on plasma (CATT-P). The CATT-FP was repeated on impregnated filter papers stored at ambient and refrigerated temperature for 1, 3, 7 and 14 days. Another 82 patients with HAT, including 78 with a positive parasitology, were tested with the CATT-FP and duplicate filter paper samples were sent to a reference laboratory to assess reproducibility. The CATT-FP was positive in 90 of 99 patients with HAT (sensitivity: 91%). It was less sensitive than the CATT-P (mean dilution difference: -2.5). There was no significant loss of sensitivity after storage for up to 14 days both at ambient and cool temperature. Reproducibility of the CATT-FP was found to be excellent (kappa: 0.84). The CATT-FP can therefore be recommended as a screening test for HAT in areas where the use of CATT-P is not possible. Further studies on larger population samples in different endemic foci are still needed before the CATT-FP can be recommended for universal use. [ABSTRACT FROM AUTHOR]

Cysticercosis is an infestation of Cysticercus cellulosae. When it occurs in the brain, chronic neurological complications can ensue, most commonly seizures. Neurocysticercosis is usually diagnosed by neuroimaging, a technique not available in most endemic countries. Hence immunological tests are valuable for diagnosis and epidemiological surveys. We evaluated the suitability of paper for storing blood and cerebrospinal fluid (CSF) until subsequent testing by enzyme-linked immunosorbent assay (ELISA), by testing whole blood samples on filter paper from 305 patients and CSF samples from 117 patients stored on ordinary white typing paper and on filter paper. Optimal preservation of biological samples is achieved when whole blood is stored on filter paper, CSF on white paper, and when samples are frozen within 1 week after collection. Our results could improve diagnostic capabilities and facilitate epidemiological surveys in endemic countries where immunodiagnostic tests cannot be rapidly performed because of inadequate laboratory infrastructure. [ABSTRACT FROM AUTHOR]

Alcohol and other drugs (AOD) use is a significant public health issue and is associated with high mortality and morbidity rates. Despite this, people who use drugs are often reluctant to seek care due to the lack of trauma‐informed treatment and harm reduction treatment options, as well as experiences of stigma and discrimination in health services. Arguably, AOD education that is co‐produced with people who use alcohol and drugs can enhance future health professionals' ability to practice in ways that support the needs of this population. This paper reports on a qualitative co‐evaluation of a co‐produced undergraduate nursing AOD subject. The AOD subject was co‐planned, co‐designed, co‐delivered, and co‐evaluated with experts by experience, who have a lived experience of substance dependence and work as advocates and peer workers. Following the delivery of the subject in 2021 and 2022, focus groups were undertaken with 12 nursing students. Focus group data indicate that the co‐produced subject supported participants to understand and appreciate how stigma impacts on nursing care and how to recognize and undertake 'good' nursing care that was oriented to the needs of service users. Student participants noted that being co‐taught by people who use drugs was particularly powerful for shifting their nursing perspectives on AOD use and nursing care and took learning beyond what could be understood from a book. Findings indicate that co‐produced AOD education can shift nursing students' perceptions of AOD use by providing access to tacit knowledge and embodied equitable and collaborative relationships with people who use drugs. [ABSTRACT FROM AUTHOR]

Background: Efforts to empower adolescent girls remain constrained by confusion around how to conceptually define empowerment and how to design interventions. More research, particularly among young adolescents, is needed that considers contextual and age-specific circumstances. This paper examines the latent classes of empowerment among early adolescent girls in Bangladesh and factors associated with membership in these classes. Using data from the Bangladeshi Association for Life Skills, Income, and Knowledge for Adolescents project, a four-arm randomized controlled trial designed to evaluate different community-based approaches for adolescents' skills development, we identify the latent classes before and after intervention and explore whether girls' membership in the study arms was associated with latent class membership at endline.Methods: To identify underlying subgroups among the sample, we conducted latent class analysis at baseline and endline using indicators of seven different constructs of empowerment based on the literature. Using multinomial logistic regression analysis, we assessed whether respondents' background characteristics and membership in the study arms were predictive of latent class membership at both timepoints.Results: A three-class model at baseline and a four-class model at endline showed optimal fit. In both models, three distinct latent classes were observed: (1) a least empowered class, (2) a mobile, socially active class, and (3) a socially progressive class. At endline, a fourth class emerged-the most empowered-that was mobile, socially active, and socially progressive. Girls' marital status, religion, and parents' level of education predicted latent class membership; household wealth was predictive at baseline, but not endline. Study arm was also associated with class membership at endline: girls in the Gender-Rights Awareness Arm had the highest probability of belonging to the fourth, most empowered class.Conclusion: This paper identifies and characterizes latent classes of empowerment that exist among the sample before and after the intervention. The apparent differential effects of interventions in predicting latent class membership have implications for community-based programming. Findings suggest that skills-building curriculum focused on promoting gender equitable norms, voice, and agency has potential to influence early adolescent girls across multiple dimensions of empowerment. [ABSTRACT FROM AUTHOR]

Aim: To evaluate safety and motor function after treatment with allogeneic umbilical cord blood (AlloCB) or umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy (CP).Method: Ninety-one children (52 males, 39 females; median age 3 years 7 months [range 2-5 years]) with CP due to hypoxic-ischemic encephalopathy, stroke, or periventricular leukomalacia were randomized to three arms: (1) the AlloCB group received 10 × 107 AlloCB total nucleated cells (TNC) per kilogram at baseline (n = 31); (2) the hCT-MSC group received 2 × 106 hCT-MSC at baseline, 3 months, and 6 months (n = 28); (3) the natural history control group received 10 × 107 AlloCB TNC per kilogram at 12 months (n = 31). Motor function was assessed with the Gross Motor Function Measure-66 (GMFM-66) and Peabody Developmental Motor Scale, Second Edition.Results: Infusions (n = 143) were well tolerated, with eight infusion reactions (three in the AlloCB group, five in hCT-MSC) and no other safety concerns. At 12 months, the mean differences (95% confidence intervals [CI]) between actual and expected changes in GMFM-66 score were AlloCB 5.8 points (3.4-8.2), hCT-MSC 4.3 (2.2-6.4), and natural history 3.1 (1.4-5.0). In exploratory, post hoc analysis, the mean GMFM-66 score (95% CI) of the hCT-MSC group was 1.4 points higher than natural history (-1.1 to 4.0; p = 0.27), and the AlloCB group was 3.3 points higher than natural history (0.59-5.93; p = 0.02) after adjustment for baseline Gross Motor Function Classification System level, GMFM-66 score, and etiology.Interpretation: High-dose AlloCB is a potential cell therapy for CP and should be further tested in a randomized, blinded, placebo-controlled trial.What This Paper Adds: Unrelated donor allogeneic umbilical cord blood (AlloCB) and human umbilical cord tissue-derived mesenchymal stromal cell infusion is safe in young children with cerebral palsy. Significant changes in motor function were not observed 6 months after treatment. One year later, treatment with AlloCB was associated with greater increases in Gross Motor Function Measure-66 scores. [ABSTRACT FROM AUTHOR]

This paper provides guidance for researchers with some mathematical background on the conduct of time-to-event analysis in observational studies based on intensity (hazard) models. Discussions of basic concepts like time axis, event definition and censoring are given. Hazard models are introduced, with special emphasis on the Cox proportional hazards regression model. We provide check lists that may be useful both when fitting the model and assessing its goodness of fit and when interpreting the results. Special attention is paid to how to avoid problems with immortal time bias by introducing time-dependent covariates. We discuss prediction based on hazard models and difficulties when attempting to draw proper causal conclusions from such models. Finally, we present a series of examples where the methods and check lists are exemplified. Computational details and implementation using the freely available R software are documented in Supplementary Material. The paper was prepared as part of the STRATOS initiative. [ABSTRACT FROM AUTHOR]

To undertake a literature search and critical appraisal of best available evidence to answer the clinical question: Does the addition of clonidine (I) to standard treatment with an opioid (C) improve outcomes (O) in infants with Neonatal Abstinence Syndrome? A search of both comprehensive (MedLine and Embase) and pre-filtered databases (Dynamed, UpToDate and TRIP), utilising Boolean Operators to combine search terms appropriately. Three relevant studies were identified. One paper describing the outcomes of a randomised controlled trial by Agthe et al. (2009) most accurately answered the clinical question posed. This paper was critically appraised, and evidence applied to the clinical scenario. The use of clonidine as an adjunct to opioid in the management of infants with NAS reduces the total number of treatment days and dose of opioid required to control symptoms. However, there is a higher risk of rebound in symptoms post-cessation of opioid and clinicians need to account for this in their discharge planning. More large scale, multi-centre high-quality research is needed to clarify the role of clonidine in the treatment of NAS: as monotherapy versus adjunct, the optimal dose and longer-term impact on neurodevelopment. [ABSTRACT FROM AUTHOR]

Aim. The aim of this paper is to identify the broad epistemological debates which underpin conflicting statements on ‘rigour’ and ‘good practice’ in qualitative research; to relate divergences in statements of ‘good practice’ in focus group design made by the pre-eminent commentators on focus group methodology to these broader epistemological debates; and to stimulate further reflection on the range of possible uses for focus groups in health services research. Considerations of the analysis of focus group data are beyond the scope of this paper. Discussion. Focus groups are a popular form of qualitative data collection, and may be defined as a particular form of group interview intended to exploit group dynamics. While qualitative research may be broadly characterized as concerned with exploring people's lived experiences and perspectives in context, it is a heterogeneous field incorporating many theoretical traditions. Consequently, qualitative researchers may be informed by a wide range of assumptions about the nature of knowledge (epistemology). These assumptions, whether implicit or explicit, have important consequences for claims about rigour and ‘good practice’ in data collection. Thus, while there is broad agreement over the general form of focus groups, statements of ‘good practice’ in terms of its application are varied. A close reading of texts by the two pre-eminent commentators on the practical application of focus groups identifies differences in ‘best practice’ focus group design related to their respective epistemological assumptions, and differences principally related to sampling techniques, composition of groups, the perceived role of group interaction and the nature of inference. Conclusion. Explicit consideration of the epistemological basis of divergent statements of ‘best practice’ in focus group design forces health services researchers to balance the demands of theory with the practicalities of conducting focus group research within complex host organisations; and encourages readers to apply appraisal criteria appropriate to the stated intentions of researchers. [ABSTRACT FROM AUTHOR]

Psychiatric genomics research with African populations comes with a range of practical challenges around translation of psychiatric genomics research concepts, procedures, and nosology. These challenges raise deep ethical issues particularly around legitimacy of informed consent, a core foundation of research ethics. Through a consideration of the constitutive function of language, the paper problematises like-for-like, designative translations which often involve the 'indigenization' of English terms or use of metaphors which misrepresent the risks and benefits of research. This paper argues that effective translation of psychiatric genomics research terminology in African contexts demands substantive engagement with African conceptual schemas and values. In developing attenuated forms of translational thinking, researchers may recognise the deeper motivational reasons behind participation in research, highlighting the possibility that such reasons may depart from the original meaning implied within informed consent forms. These translational issues might be ameliorated with a critical re-examination of how researchers develop and present protocols to institutional ethics review boards. [ABSTRACT FROM AUTHOR]

Introduction: Virtual reality (VR) technology is a potential method to use in cognitive intervention, but the use of VR in cognitive stimulation intervention for older adults has not been investigated. Therefore, the aim of this study was to investigate the mood change of older adults after participating in the VR cognitive stimulation activity.Methods: This is a multicenter randomized controlled, cross-over trial. The intervention was a VR cognitive stimulation activity, and the control was a paper-and-pencil activity. The participants were older adults with age over 60 and recruited in the elderly community centers. The Positive and Negative Affect Score (PANAS) was used to measure mood change. Mean difference (MD) with 95% confidence interval (95% CI) was calculated. The Simulator sickness questionnaire was used to measure adverse events.Results: A total of 236 participants from 19 community centers were recruited. After the VR activity, the participants had a significant increase in total PANAS positive affect score (MD = 2.09, 95% CI = 0.69 to 3.49), and a significant reduction in total negative affect score (MD = -1.99, 95% CI = -2.55 to -1.43). The reduction in negative affect score was significantly larger in VR activity than paper-and-pencil activity (MD = -0.48, 95% CI = -0.98 to 0.00). Besides, only three participants reported severe advance events after VR activity.Conclusions: The use of VR technology is well accepted by older adults. Therefore, the use of VR technology through smartphone and a mobile app can be a potential method for future cognitive training interventions. [ABSTRACT FROM AUTHOR]

Introduction: This paper accomplishes two goals. First, we assesses the measurement invariance of legal cynicism among adolescents in São Paulo, Brazil, Montevideo, Uruguay, and Zurich, Switzerland. Second, we evaluate a series of social and individual antecedents that are expected to influence legal cynicism across contexts.Methods: This paper first evaluates the measurement invariance of legal cynicism using Multigroup Confirmatory Factor Analysis with three randomized clustered samples of adolescents in Zurich (n = 1447), São Paulo (n = 2680) and Montevideo (n = 2204). Second, we assessed the correlates for legal cynicism in each city using structural equation modelling techniques.Results: The results demonstrated metric invariance, but not scalar invariance among adolescents in São Paulo, Zurich, and Montevideo. We were able to establish partial measurement invariance for legal cynicism in São Paulo and Zurich, and therefore proceeded with the comparison of latent means and antecedents. The results show that on average legal cynicism is higher in Zurich, but that the size and strength of antecedents were similar across cities. Low self-control was by far the strongest correlate of legal cynicism.Conclusions: Overall, our results suggest that current operationalizations of legal cynicism may not be rooted in social structural context and experiences with legal authorities, but rather reflect how individuals interpret legal boundaries and dispositions towards rule-breaking. Researchers must reconsider how legal cynicism fits into models of legal socialization, and whether developmental models of self-control may help us understand the origins and nature of legal cynicism, as it is currently measured. [ABSTRACT FROM AUTHOR]

Aim: To determine if pain is associated with 12-month incidence of mood affective disorders (MAD) in adults with cerebral palsy (CP).Method: Data from Optum Clinformatics® Data Mart (2013-2016) were used for this retrospective cohort study. Diagnostic codes were used to identify adults (≥18y) with CP, incident cases of MAD, and covariates (other neurodevelopmental conditions, sleep disorders, arthritis). Pain (any type, location) was identified between 1st October 2014 and 30th September 2015. The pain group was divided into new or consistent pain if they had a history of pain (i.e. consistent) in the 12 months before their first pain claim date. Crude incidence rates of MAD (expressed per 100 person-years) were estimated. Cox regression was used to estimate hazard ratio (95% confidence interval [CI]) of MAD after adjusting for covariates.Results: Adults that had new pain (n=859; incidence rate=15.5) or consistent pain (n=1303; incidence rate=17.9) had greater crude incidence rate of MAD compared to adults without pain (n=3726; incidence rate=5.9). The elevated rate of MAD remained after adjusting for covariates, for new pain (hazard ratio=2.4; 95% CI=1.9-3.0) and consistent pain (hazard ratio=2.1; 95% CI=1.7-2.7).Interpretation: Pain is associated with greater incidence of MAD in adults with CP. This association remained after accounting for potential confounding factors.What This Paper Adds: What this paper adds Pain was associated with higher 12-month incidence of mood affective disorders (MAD). The 12-month MAD incidence was similar between new and consistent pain groups. The MAD incidence remained higher adjusting for neurodevelopmental comorbidities, sleep disorders, and arthritis. [ABSTRACT FROM AUTHOR]

The effective collection and management of personal data of rapidly migrating populations is important for ensuring adequate healthcare and monitoring of a displaced peoples' health status. With developments in ICT data sharing capabilities, electronic personal health records (ePHRs) are increasingly replacing less transportable paper records. ePHRs offer further advantages of improving accuracy and completeness of information and seem tailored for rapidly displaced and mobile populations. Various emerging initiatives in Europe are seeking to develop migrant-centric ePHR responses. This paper highlights their importance and benefits, but also identifies a number of significant ethical, legal and social issues (ELSI) and challenges to their design and implementation, regarding (1) the kind of information that should be stored, (2) who should have access to information, and (3) potential misuse of information. These challenges need to be urgently addressed to make possible the beneficial use of ePHRs for vulnerable migrants in Europe. [ABSTRACT FROM AUTHOR]

Stepped-wedge cluster randomized trials, which randomize clusters of subjects to treatment sequences in which clusters switch from control to intervention conditions, are being conducted with increasing frequency. Due to the real-world nature of this design, methodological and implementation challenges are ubiquitous. To account for such challenges, more complex statistical models to plan studies and analyze data are required. In this paper, we consider stepped-wedge trials that accommodate treatment effect heterogeneity across clusters, implementation periods during which no data are collected, or both treatment effect heterogeneity and implementation periods. Previous work has shown that the sequence-period cells of a stepped-wedge design contribute unequal amounts of information to the estimation of the treatment effect. In this paper, we extend that work by considering the amount of information available for the estimation of the treatment effect in each sequence-period cell, sequence, and period of stepped-wedge trials with more complex designs and outcome models. When either treatment effect heterogeneity and/or implementation periods are present, the pattern of information content of sequence-period cells tends to be clustered around the times of the switch from control to intervention condition, similarly to when these complexities are absent. However, the presence and degree of treatment effect heterogeneity and the number of implementation periods can influence the information content of periods and sequences markedly. [ABSTRACT FROM AUTHOR]

Background: Early plasma transfusion is life-saving for bleeding trauma patients. Freeze-dried plasma (FDP) provides unique formulation advantages for infusion in the prehospital setting. We describe characterization and clinical safety data of the first, next-generation FDP stored in plastic bags with rapid reconstitution.Study Design and Methods: Coagulation and chemistry parameters on 155 pairs of fresh frozen plasma (FFP) and their derivative FDP units were compared. Next, a first-in-human, dose-escalation safety evaluation of FDP, involving 24 healthy volunteers who donated either whole blood or apheresis plasma to create autologous FDP, was performed in three dose cohorts (270, 540, and 810 ml) and adverse events (AEs) were monitored. Cohort 3 was randomized, double-blind with a cross-over arm that compared FDP versus FFP using descriptive analysis for AEs, coagulation, hematology, and chemistry parameters.Results: FDP coagulation factors, clotting times, and product quality (pH, total protein, and osmolality) post-lyophilization were preserved. FDP infusions, of up to 810 ml per subject, were found to be safe and with no serious AEs (SAEs) related to FDP. The average time to reconstitute FDP was 67 s (range: 43-106). No differences in coagulation parameters or thrombin activation were detected in subjects infused with 810 ml of FDP compared with FFP.Conclusion: This first next-generation FDP product preserves the potency and safety of FFP in a novel rugged, compressible, plastic container, for rapid transfusion, allowing rapid access to plasma in resuscitation protocols for therapy in acute traumatic hemorrhage. [ABSTRACT FROM AUTHOR]

Objective: There is a growing interest in how people living with dementia may achieve good outcomes and be resilient despite their health challenges. Understanding what might be important for resilience in this population is largely untested theory.Methods: The analysis draws a subsample with cognitive impairment (N = 579) from two waves of the Cognitive Function and Ageing Studies Wales study, a nationally representative study of community-dwelling people aged 65+ in Wales. We constructed a measure of mental health resilience (MHR) defined as no depression, no anxiety and high well-being. Drawing on a resilience framework, we tested univariate and cumulative effects models of the factors that enable MHR, and then examined whether MHR is important for reducing loneliness over time.Results: Across both waves of data 22% (n = 121) met the criteria for MHR. The cumulative effects model found the odds of MHR were greater for male gender, higher self-esteem, greater social resources and no subjective memory complaints. Controlling for these significant predictors, MHR significantly predicted lower total and sub-scale scores for loneliness at wave 2. Sensitivity analysis shows these effects held at lower levels of cognitive function when the Mini-Mental State Examination score was <25, but not at <23.Conclusions: This paper addresses a gap in research regarding the conceptualisation and measurement of resilience when facing cognitive impairment. Understanding what aspects of a person's life might enable good mental health despite cognitive impairment-to be resilient-could inform effective strategies for friends and families, along with health, and social policy and practice. [ABSTRACT FROM AUTHOR]

Violent ideations are increasingly recognized as an important psychological predictor for aggressive and violent behavior. However, little is known about the processes that contribute to violent ideations. This paper examines the extent to which polyvictimization triggers violent ideations in late adolescence and early adulthood, while also adjusting for dispositional and situational factors as well as prior violent ideations. Data came from three waves of the Zurich Project on the Social Development from Childhood into Adulthood (z-proso; n = 1465). Full-information maximum likelihood Tobit models were fitted to regress violent ideations experienced at ages 17 and 20 on multiple victimization experiences in the preceding 12 months while controlling for antecedent developmental risk factors and prior violent ideations. The results showed that violent ideations in late adolescence and early adulthood are influenced by violent thoughts, aggressive behavior, violent media consumption, moral neutralization of violence, and internalizing symptoms measured 2 years earlier. Experiences of polyvictimization significantly contributed to an increase in violent ideations both during late adolescence and in early adulthood. The exposure-response relationship between victimization and violent ideations did not significantly differ by sex. The findings are consistent with the notion that violent ideations are triggered by a retaliation-linked psychological mechanism that entails playing out other directed imaginary aggressive scenarios specifically in response to experiencing intentional harm-doing by others. [ABSTRACT FROM AUTHOR]

Aim: To validate the Whitney Comorbidity Index (WCI), which was recently developed to monitor disease status for adults with cerebral palsy (CP), and to identify WCI scores associated with an increased mortality risk using a representative sample of adults with CP.Method: Data from 2016 to 2018 were used from a random 20% sample from the fee-for-service Medicare database for this retrospective cohort study. The WCI was examined as unweighted (WCIunw ) and weighted (WCIw ) among adults at least 18 years old with CP. Cox regression models were developed with mortality as the outcome after adjusting for demographics. A concordance statistic (C-statistic) of at least 0.70 was considered as showing sufficient validity. The hazard ratio of mortality for each WCI score was estimated. Secondary analyses were performed for subgroups with co-occurring epilepsy and/or intellectual disabilities.Results: For the entire group (n=16 728) and subgroups, the WCI showed sufficient validity (C-statistic 0.73-0.81). For the entire group, the mortality rate was elevated for a score of 1 compared with 0 from the WCIunw (hazard ratio 3.06; 95% confidence interval [CI] 1.52-6.17) and WCIw (hazard ratio 4.08; 95% CI 1.69-9.85), and became larger with each WCI score. Results were similar for the subgroups.Interpretation: The WCI is a valid marker for health/disease status for adults with CP. Several WCI score thresholds were identified to assist in clinical decision making for preventive medicine and intervention implementation. What this paper adds The Whitney Comorbidity Index (WCI) is valid among 16 728 adults with CP. The WCI is valid for those with co-occurring epilepsy and/or intellectual disabilities. Thresholds of the WCI score were identified to assist clinical decision making. [ABSTRACT FROM AUTHOR]

Aim: To determine if walking ability and presence of intellectual disability and epilepsy change from childhood to 50 years of age in individuals with cerebral palsy (CP), and if such changes are related to age, sex, or CP subtype.Method: This was a population-based follow-up study of 142 adults born from 1959 to 1978 (82 males, 60 females; mean age 48y 4mo, range 37-58y; 44% unilateral, 35% bilateral, 17% dyskinetic, and 4% ataxic CP) listed in the CP register of western Sweden. We compared childhood data with a follow-up assessment in 2016.Results: At follow-up, walking ability had changed significantly (p<0.001). The proportion of participants walking without aids had decreased from 71% to 62%, and wheelchair ambulation increased from 18% to 25%. Walking ability was related to subtype (p=0.001), but not to age, sex, pain, fatigue, or body mass index. The proportion classified as having intellectual disability had increased from 16% to 22% (p=0.039) and the proportion with epilepsy from 9% to 18% (p=0.015). Of those with childhood epilepsy, 46% were seizure-free without medication.Interpretation: Walking ability and the presence of intellectual disability and epilepsy had changed significantly since childhood. Life-long access to specialized health care is warranted for re-evaluation of impairments, treatment, and assistance. What this paper adds Changes in impairments in individuals with cerebral palsy (CP) over time are related to CP subtype. After 50 years, walking ability in CP may have deteriorated or improved. Intellectual disability in CP may not always be detected in early childhood assessments. Epilepsy in CP may develop after childhood or may be outgrown. [ABSTRACT FROM AUTHOR]

Aim: We explored the psychometric properties of the recently developed Tyneside Pegboard Test (TPT) for unimanual and bimanual dexterity in children with unilateral cerebral palsy (CP) and investigated the impact of sensorimotor impairments on manual dexterity.Method: In this cross-sectional study, the TPT was assessed in 49 children with unilateral CP (mean age 9y 8mo, SD 1y 11mo, range 6-15y; 30 males, 19 females; 23 with right unilateral CP). All participants additionally underwent a standardized upper limb evaluation at body function and activity level. We investigated: (1) known-group, concurrent, and construct validity and (2) impact of sensorimotor impairments including spasticity, grip force, stereognosis, and mirror movements using analysis of covariance, Spearman's rank correlation (r), and multiple linear regression (R2 ) respectively.Results: TPT outcomes significantly differed according to the Manual Ability Classification System (p<0.001, known-group validity). Relationships were found between the unimanual TPT tasks and the Jebsen-Taylor Hand Function Test (r=0.86-0.88, concurrent validity). Bimanual TPT tasks were negatively correlated with the Assisting Hand Assessment, ABILHAND-Kids, and Children's Hand-use Experience Questionnaire (r=-0.38 to -0.78, construct validity). Stereognosis was the main determinant influencing all tasks (p<0.001, R2 =37-50%). Unimanual dexterity was additionally determined by grip strength (p<0.05, R2 =8-9%) and mirror movements in the more impaired hand (p<0.05, R2 =4-8%). Bimanual dexterity was also explained by mirror movements in the more impaired hand (p<0.01, R2 =10-16%) and spasticity (p=0.04, R2 =5%).Interpretation: The TPT is a valid test to measure unimanual and bimanual dexterity in unilateral CP. The results further emphasize the importance of somatosensory impairments in children with unilateral CP. What this paper adds The Tyneside Pegboard Test is valid for measuring unimanual and bimanual dexterity in unilateral cerebral palsy. Children with poorer manual ability show worse unimanual and bimanual dexterity. Stereognosis is the main predictor of both unimanual and bimanual dexterity. Stronger mirror movements in the more impaired hand result in worse bimanual dexterity. [ABSTRACT FROM AUTHOR]

Aim: To evaluate an innovative paediatric neurorehabilitation model in relation to improving quality of neurorehabilitation and reducing length of stay (LOS) for children with acquired brain injury.Method: A process evaluation approach was conducted in line with Medical Research Council evaluation of complex interventions guidance. Analysis was conducted on routinely collected patient data from 2017 to 2018, including LOS and family feedback. Descriptive and inferential statistics were used for quantitative analysis and qualitative data was analysed thematically.Results: Outcomes for 70 children (0-16y, median age 5y, IQR 1-11y, 46 males, 24 females) referred to the service indicated improved function and reduced complexity of need. The mean LOS was 10.6 days compared to baseline mean LOS of 41 days (2011-2012). High satisfaction from the families was recorded; however, ongoing needs and service gaps regarding long-term support were identified.Interpretation: This service model is effective in delivering quality paediatric neurorehabilitation, demonstrating a sustained impact on LOS, and positive patient outcome data and family feedback for this group of patients. What this paper adds Investment in early intensive neurorehabilitation and supported discharge impacts length of stay (LOS) for children with acquired brain injury. Early intensive neurorehabilitation and supported discharge is effective. This is demonstrated by a sustained reduction in LOS, positive patient outcomes, and family feedback. [ABSTRACT FROM AUTHOR]

Clinical studies on periodontal disease (PD) often lead to data collected which are clustered in nature (viz. clinical attachment level, or CAL, measured at tooth-sites and clustered within subjects) that are routinely analyzed under a linear mixed model framework, with underlying normality assumptions of the random effects and random errors. However, a careful look reveals that these data might exhibit skewness and tail behavior, and hence the usual normality assumptions might be questionable. Besides, PD progression is often hypothesized to be spatially associated, that is, a diseased tooth-site may influence the disease status of a set of neighboring sites. Also, the presence/absence of a tooth is informative, as the number and location of missing teeth informs about the periodontal health in that region. In this paper, we develop a (shared) random effects model for site-level CAL and binary presence/absence status of a tooth under a Bayesian paradigm. The random effects are modeled using a spatial skew-normal/independent (S-SNI) distribution, whose dependence structure is conditionally autoregressive (CAR). Our S-SNI density presents an attractive parametric tool to model spatially referenced asymmetric thick-tailed structures. Both simulation studies and application to a clinical dataset recording PD status reveal the advantages of our proposition in providing a significantly improved fit, over models that do not consider these features in a unified way. [ABSTRACT FROM AUTHOR]

Aims: Patients surviving an acute myocardial infarction (AMI) are at risk of developing symptomatic heart failure (HF) or premature death. We hypothesized that sacubitril/valsartan, effective in the treatment of chronic HF, prevents development of HF and reduces cardiovascular death following high-risk AMI compared to a proven angiotensin-converting enzyme (ACE) inhibitor. This paper describes the study design and baseline characteristics of patients enrolled in the Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI) trial.Methods and Results: PARADISE-MI, a multinational (41 countries), double-blind, active-controlled trial, randomized patients within 0.5-7 days of presentation with index AMI to sacubitril/valsartan or ramipril. Transient pulmonary congestion and/or left ventricular ejection fraction (LVEF) ≤40% and at least one additional factor augmenting risk of HF or death (age ≥70 years, estimated glomerular filtration rate <60 mL/min/1.73 m2 , diabetes, prior myocardial infarction, atrial fibrillation, LVEF <30%, Killip class ≥III, ST-elevation myocardial infarction without reperfusion) were required for inclusion. PARADISE-MI was event-driven targeting 708 primary endpoints (cardiovascular death, HF hospitalization or outpatient development of HF). Randomization of 5669 patients occurred 4.3 ± 1.8 days from presentation with index AMI. The mean age was 64 ± 12 years, 24% were women. The majority (76%) qualified with ST-segment elevation myocardial infarction; acute percutaneous coronary intervention was performed in 88% and thrombolysis in 6%. LVEF was 37 ± 9% and 58% were in Killip class ≥II.Conclusions: Baseline therapies in PARADISE-MI reflect advances in contemporary evidence-based care. With enrollment complete PARADISE-MI is poised to determine whether sacubitril/valsartan is more effective than a proven ACE inhibitor in preventing development of HF and cardiovascular death following AMI. [ABSTRACT FROM AUTHOR]

In this paper, I discuss the question of partiality and impartiality in the application of triage. Triage is a process in medical research which recommends that patients should be sorted for treatment according to the degree or severity of their injury. In employing the triage protocol, however, the question of partiality arises because socially vulnerable groups will be neglected since there is the likelihood that the social determinants of a patient's health may diminish her chance of survival. As a process that is based on the severity of a patient's injury, triage will be unfair, and hence negatively partial, to socially vulnerable people. Thus, I aim in this paper to show that the triage protocol fails as an impartial evaluative process because its only aim is to maximize survivability. I contend that: (i) triage would lead to the neglect of the social condition of patients or victims, and (ii) it will only serve the utilitarian purpose of maximization of outcomes which may not be justified in some cases. [ABSTRACT FROM AUTHOR]

Issues: Drug consumptions rooms (DCR) and supervised injecting facilities (SIF) are expanding internationally. Previous reviews have not systematically addressed evaluation methodologies.Approach: Results from systematic searches of scientific databases in English until June 2017 were coded for paper type, country and year of publication. For evaluation papers, study outcome, methodology/study design and main indicators of DCR/SIF 'exposure' were recorded.Key Findings: Two hundred and nineteen eligible peer-reviewed papers were published since 1999: the majority from Canada (n = 117 papers), Europe (n = 36) and Australia (n = 32). Fifty-six papers reported evaluation outcomes. Ecological study designs (n = 10) were used to assess the impact on overdose, public nuisance and crime; modelling techniques (n = 6) estimated impact on blood-borne diseases, overdose deaths and costs. Papers using individual-level data included four prospective cohorts (n = 28), cross-sectional surveys (n = 7) and service records (n = 5). Individual-level data were used to assess safer injecting practice, uptake into health and social services and all the other above outcomes except for impact on crime and costs. Four different indicators of DCR/SIF attendance were used to measure service 'exposure'.Implications: Research around DCRs/SIFs has used ecological, modelling, cross-sectional and cohort study designs. Further research could involve systematic inclusion of a control group of people who are eligible but do not access SIFs, validation of self-reported proportion of injections at SIFs or a stepped-wedge or a cluster trial comparing localities.Conclusions: Methodologies appropriate for DCR/SIF evaluation have been established and can be readily replicated from the existing literature. Research on operational aspects, implementation and transferability is also warranted. [ABSTRACT FROM AUTHOR]

Purpose: Evaluation of the available research on PEEK materials to find that whether PEEK material has favorable properties and can enhance osseointegration, so that they can be utilize as implants material. Materials and Methods: An electronic and structured systematic search was undertaken in May 2018, without any restrictions of time in the Medline/Pubmed, Sci‐hub, Ebscohost, Cochrane, and Web of Science databases. To identify other related references further hand search was done. Articles related to PEEK and their applications in implants were only included. Articles not available in abstract form and article other than English language were excluded. Results: Initially, the search resulted in 153 papers. Independent screenings of the abstracts were done by the reviewers to identify the articles related to the question in focus. Sixty‐two studies were selected out of which 10 were further excluded due to not in English language. Two additional papers were obtained after hand searching, and finally 54 articles were included in the review. Conclusions: Surface modification of PEEK seems to enhance the cell adhesion, proliferation, biocompability, and osteogenic properties of PEEK implant materials. PEEK had also influence the biofilm structure and reduces the chances of periimplant inflammations. Further research and more number of controlled clinical trials on PEEK implant is required in near future so that it can replace titanium in future. [ABSTRACT FROM AUTHOR]

Qualitative field research in any type of terrain calls for a practice‐oriented reflection on the researcher's emotional labour management in relation to the context of the field before, during, and beyond data collection. Intractable conflict environments (ICE) are characterised by long‐running social crises still unresolved. This particularity makes such contexts risk‐prone in terms of unpredictable dangers and unexpected outcomes, hence, the requirement for thorough ethical evaluation of field research designs. Field researchers, often working on their own, are expected to safely make ethically sound decisions while gathering high‐quality data within complex social realities of which they are often socio‐culturally not savvy. This inevitably exacerbates the emotional burden on the researchers and makes fieldwork challenging. Although feminist geographers notably have significantly contributed to highlighting the social dynamics of fieldwork by initiating and deepening discussions of the emotional and ethical challenge, discussions have rarely gone beyond underlining the need for recognition of the field researchers' emotional labour. Despite academic consensus for reflexive analysis and field diary‐keeping, little has been discussed on how to systematically manage this effort during the research process. In this paper, building on the first author's PhD fieldwork experience in Israel and the West Bank area, we propose a paced field research organisation method – PFROM – which systematically accommodates time and space for the researcher's engagement with and detachment from the field research's intensity. Applying the concept of pacing – intentionally distributing focused attention in such a way that will reduce fatigue prior to the completion of a task – this framework systematically integrates reflexivity within research designs. The PFROM provides researchers with a tool applicable beyond intractable conflict contexts which has the potential to enhance their emotional labour management. [ABSTRACT FROM AUTHOR]

Aim: To evaluate if autism symptoms and diagnoses are more common in children with neurofibromatosis type 1 (NF1) than in typically developing children, to which levels, and to determine if co-occurring attention-deficit/hyperactivity disorder (ADHD) symptomatology accounts for this increase.Method: We searched hospital electronic medical records (EMR) for International Classification of Diseases, 10th Revision NF1 and co-occurring diagnoses codes. We recruited a subsample of 45 children (mean age 9y 2mo; SD 2y 7mo; range 5-12y; 22 males, 23 females) and collected parental reports of autism symptomatology, adaptive behavior, and behavioral problems that were compared to those of 360 age- and sex-matched controls from the Simons Simplex Collection (SSC) with autism spectrum disorder (ASD; SSC-ASD) or typically developing (SSC-TD).Results: The EMR search identified 968 children with NF1; 8.8% had ADHD and 2.1% had ASD co-occurring diagnoses. In the subsample, the mean autism scale score for participants with NF1 was below cut-off for significant autism symptoms. Participants with NF1 had significantly more autism and behavioral symptoms than SSC-TD participants, and significantly less than SSC-ASD participants, with one exception: ADHD symptom levels were similar to those of SSC-ASD participants. In analyses that controlled for internalizing, ADHD, and communication scores, the difference in autism symptom levels between participants with NF1 and typically developing controls disappeared almost entirely.Interpretation: Our results do not support an association between NF1 and autism, both at the symptom and disorder levels.What This Paper Adds: Diagnoses of attention-deficit/hyperactivity disorder (ADHD) were more common in children with neurofibromatosis type 1 (NF1) than in the general child population. Diagnoses of autism spectrum disorder were no more common in children with NF1 than in the general child population. Increases in autism symptoms did not reach clinically significant thresholds. Co-occurring ADHD symptoms accounted for increased autism questionnaire scores. Adaptive behavior in participants with NF1 showed normal socialization but lower communication proficiency. [ABSTRACT FROM AUTHOR]

Clinical prediction models (CPMs) can predict clinically relevant outcomes or events. Typically, prognostic CPMs are derived to predict the risk of a single future outcome. However, there are many medical applications where two or more outcomes are of interest, meaning this should be more widely reflected in CPMs so they can accurately estimate the joint risk of multiple outcomes simultaneously. A potentially naïve approach to multi-outcome risk prediction is to derive a CPM for each outcome separately, then multiply the predicted risks. This approach is only valid if the outcomes are conditionally independent given the covariates, and it fails to exploit the potential relationships between the outcomes. This paper outlines several approaches that could be used to develop CPMs for multiple binary outcomes. We consider four methods, ranging in complexity and conditional independence assumptions: namely, probabilistic classifier chain, multinomial logistic regression, multivariate logistic regression, and a Bayesian probit model. These are compared with methods that rely on conditional independence: separate univariate CPMs and stacked regression. Employing a simulation study and real-world example, we illustrate that CPMs for joint risk prediction of multiple outcomes should only be derived using methods that model the residual correlation between outcomes. In such a situation, our results suggest that probabilistic classification chains, multinomial logistic regression or the Bayesian probit model are all appropriate choices. We call into question the development of CPMs for each outcome in isolation when multiple correlated or structurally related outcomes are of interest and recommend more multivariate approaches to risk prediction. [ABSTRACT FROM AUTHOR]

Objective: There is an urgent need to test and incorporate new molecules with promising efficacy and novel mode of action to control insecticide-resistant mosquito vectors for disease control. We tested a new compound, clothianidin (SumiShield 50 WG), for its efficacy as an indoor residual spray (IRS) for the control of pyrethroid-resistant Anopheles culicifacies (Diptera: Culicidae) in comparison with pirimiphos methyl (Actellic CS) as a positive control.Methods: Ten villages were selected, five each for IRS with clothianidin (300 mg AI/m2 ) and pirimiphos methyl (1000 mg AI/m2 ) in Almatti Dam catchment area in Karnataka state, India. Entomological parameters were monitored in these sprayed villages using standard methods. Assessment of quality of spray was performed by analysing the insecticide content in the filter paper samples collected from sprayed houses. Perceptions of spray men and inhabitants were recorded post-spray on safety of these molecules.Results: The mean applied to target ratio of content was 1.7 (n = 29) for clothianidin and 1.8 (n = 50) for pirimiphos methyl on filter paper samples analysed. Residual activity (≥80% mortality in exposed mosquitoes) after 24 h post-exposure of SumiShield WG was 5 months and increased to 6 months when the holding period was extended to 120 h and that of Actellic CS was 3 months at 24-h holding period and extended to 4 months at 120-h extended holding period. The mean densities of An. culicifacies in both arms fell drastically post-spray. In light trap collections, density of mosquitoes collected indoors was lower than outdoors in both arms indicating effectiveness of IRS. SumiShield WG was more efficacious in reducing the per-structure density than Actellic CS. The proportion of nulliparous mosquitoes was higher than that of parous mosquitoes during post-spray collections in both arms. The majority of adverse events reported were transitory and subsided without medication.Conclusion: Indoor residual spraying with SumiShield WG was found effective, operationally feasible and safe, and it is effective for up to 6 months. [ABSTRACT FROM AUTHOR]

Aim: To investigate the efficacy of waiting room media for reducing anxiety and increasing satisfaction at a paediatric rehabilitation hospital.Method: In this clustered, parallel, randomized controlled trial, 310 young people with disabilities (age range 5-19y) and their parents attending outpatient clinics were assigned to interactive media (n=113), a silent nature video (n=97), or media-free comparison (n=100) groups. Young person and parent anxiety was reported using the State-Trait Anxiety Inventory (STAI) on arrival and after 10 minutes in the waiting space. Questionnaires measured young person, parent, and staff satisfaction.Results: Young people exposed to interactive media reported a postexposure state anxiety that was 1.1 raw points (2.7 standardized points) lower on the STAI than the comparison group (95% confidence interval [CI] -1.9 to -0.22). There was no difference in postexposure state anxiety between the passive media and comparison groups (95% CI -0.64 to 1.1). Parents' state anxiety did not differ between conditions, but interactive media were associated with greater satisfaction (p=0.009). Of 120 staff, 119 reported that interactive media improved the clinic experience for families.Interpretation: Interactive media designed for accessible, hands-free play mitigate waiting anxiety and increases satisfaction. This paper provides evidence to guide design and decision-making around the use of interactive media in health care spaces.What This Paper Adds: Interactive media reduced preclinic waiting anxiety for young people with disabilities. Interactive media were accessible to young people with a range of mobility. Interactive media increased parental and staff satisfaction in the clinic. Guidelines for the design of hands-free, inclusive interactive media for health care facilities are presented. [ABSTRACT FROM AUTHOR]

In the medical practice in China, giving and taking "red envelopes" (monetary gifts) is a common phenomenon although few openly admit it. This paper, based on our empirical study including data collected from interviews and questionnaires with medical professionals and patients, attempts to explore why "red envelopes" have become a serious problem in the physician-patient relationship and how the situation can be improved. Previous studies show that scholars tend to correlate the spread of "red envelopes" in health care sector to the commercialization trend, the general erosion of traditional values, and the lowering of the moral level in the medical field. However, in this paper, the authors argue that medical professionals' choice of taking "red envelopes" is actually more a way to compensate for their problematic self-image and marred dignity in real practice. Medical professionals in China as a whole are in an embarrassing situation where the work pressure and income, and the sense of pride that used to be part of their profession are not comparable to each other. Under this circumstance, we believe that the effective way to deal with the "red envelopes" issue does not lie solely in introducing more stringent regulations or granting medical professionals higher payments, but rather in protecting and enhancing the professional dignity of all those working in healthcare. And on top of that, there must also be effort to cultivate a more favorable moral environment. [ABSTRACT FROM AUTHOR]

Objective Aboriginal people experience a higher burden of disease as a consequence of drug and alcohol (D&A) abuse. Although media campaigns can be a popular tool for disseminating health promotion messages, evidence of the extent to which they reduce the impact of substance abuse is limited, especially for rural Aboriginal communities. This paper is the first to examine the impact a locally designed D&A radio advertising campaign for Aboriginal people in a remote community in Western NSW. Design A post-intervention evaluation. Setting The radio campaign was implemented in Bourke, (population 2465, 30% Aboriginal). Participants Fifty-three community surveys were completed. Main outcome measure(s) The self-reported level of awareness of the campaign and the number of self-referrals to local D&A workers in the intervention period. Results Most respondents (79%) reported they listen to radio on a daily basis, with 75% reporting that they had heard one or more of the advertisements. The advertisement that was remembered best contained the voice of a respected, local person. There was one self-referral to local health services during the intervention timeframe. Conclusion The community-led radio advertising campaign increased community awareness of substance abuse harms, but had limited impact on formal help-seeking. This paper highlights the value of radio as a commonly used, trusted and culturally relevant health promotion medium for rural communities, especially when engaging local respected Aboriginal presenters. [ABSTRACT FROM AUTHOR]

Objectives: Qigong has been shown to effectively reduce depressive symptoms in older adults with chronic physical illness. Here, we sought to evaluate the effects of qigong on serotonin, cortisol, and Brain-derived Neurotropic Factors (BDNF) levels and test their roles as potential mediators of the effects of qigong on depressive symptoms.Methods: Thirty older adults with chronic physical illness participated in a randomized clinical trial. They were randomly assigned to a qigong group (n = 14) or a control group for cognitive training of executive function and memory (n = 16). The participants provided blood and saliva samples at baseline and post-intervention. Levels of cortisol were measured from the salvia samples, and serotonin and BDNF were measured from the blood samples.Results: Consistent with the study findings presented in the primary outcome paper, a significant Group × Time interaction effect emerged on depressive symptoms, explained by greater reductions in the qigong group than the control group. Qigong participants had significantly larger increases in serotonin and BDNF, and decreases in cortisol levels, compared with control group participants. Moreover, treatment-related changes in cortisol levels (but not serotonin or BDNF) fully mediated the beneficial effects of qigong on depressive symptoms.Conclusion: The findings provide preliminary evidence that treatment-related changes in cortisol may mediate the benefits of qigong on depressive symptoms. Given the limitation of small sample size of the present study, future studies with larger sample sizes and more extended follow-up assessment are warranted to determine the reliability of these findings. [ABSTRACT FROM AUTHOR]

Aim: To investigate the utility of the Insight Inventory (a structured clinical inventory completed by caregivers) for assessment of children with cerebral visual impairment; and to investigate effectiveness of tailored habilitational strategies derived from the responses to the Insight Inventory.Method: Fifty-one eligible children (26 males, 25 females; mean age 9y 5mo, SD 3y, range 5-16y) were recruited from Great Ormond Street Hospital, London. They underwent baseline assessment including neuro-ophthalmological and neuropsychological evaluations, and parent- and child-reported ratings on a questionnaire-based measure of quality of life. Parents also completed the Insight Inventory. On the basis of responses to the Inventory, families received individualized habilitational strategies. Follow-up assessments 6 months later included repeating the Insight Inventory and quality of life questionnaires.Results: Correlations were found between the Insight Inventory and the Wechsler Intelligence Scale for Children, Fourth Edition, the Beery-Buktenica Test of Visual-Motor Integration, and the Benton Facial Recognition Test, suggesting that the Insight Inventory is an effective tool to estimate visual-perceptual difficulties. At 6 months follow-up, caregiver reports indicated significant improvements in the quality of life of children below the age of 12 years.Interpretation: The Insight Inventory is a simple questionnaire which covers practical aspects of cognitive visual function in everyday life. It provides in-depth information about the aspects that children struggle with. It can also guide programmes of individualized habilitation strategies, which may enhance the quality of life of younger children.What This Paper Adds: Questionnaire scores demonstrate biologically plausible correlations with formal neuropsychological tests of visual function. After administration of matched practical habilitational strategies, younger children showed improvement in quality of life and functional vision scores. [ABSTRACT FROM AUTHOR]

Aim: To describe the trajectory of clinical signs in children who developed human immunodeficiency virus encephalopathy (HIVE) after starting early antiretroviral therapy (ART).Method: This was a retrospective case-cohort description of HIVE among Cape Town participants from the Children with HIV Early AntiRetroviral treatment (CHER) trial. Criteria for HIVE diagnosis were at least two of: (1) acquired central motor deficit, (2) impaired brain growth, and (3) failure to attain or loss of developmental milestones in the absence of an alternative aetiology.Results: Of 133 surviving participants who initiated ART at a median age of 9 weeks and who were followed until a median age of 6 years, 20 (12%) developed HIVE at a median age 31 months (interquartile range 19-37). In these, the first neurological deterioration was noticed at a median age of 19 months, when 16 were on ART and nine had undetectable HIV viral load for a median of 12 months. Signs of upper motor neurons were present in 18, of whom 12 resolved and four had persistent spastic diplegia; 19 had motor delay, of whom 14 resolved; 12 had language delay, of whom 11 resolved; and 16 had impaired brain growth, of whom only five recovered. For the 16 participants already on ART at HIVE diagnosis, regimens were not altered in response to diagnosis.Interpretation: HIVE may occur despite early ART initiation and virological suppression and then resolve on unchanged ART, most likely as intrathecal inflammation subsides.What This Paper Adds: Despite suppressive antiretroviral therapy, children can develop human immunodeficiency virus encephalopathy, The most common manifestations are motor deficits and impaired brain growth. Most experience improvement, with many resolving without additional intervention. [ABSTRACT FROM AUTHOR]

Aim: To evaluate pain prevalence and characteristics in children and adolescents with predominant dyskinetic and mixed (dyskinetic/spastic) cerebral palsy (CP) motor types.Method: Seventy-five participants with a diagnosis of CP and confirmed dyskinetic or mixed (dyskinetic/spastic) motor type took part in a multisite cross-sectional study. The primary outcome was carer-reported pain prevalence (preceding 2wks) measured using the Health Utilities Index-3. Secondary outcomes were chronicity, intensity, body locations, quality of life, and activity impact.Results: Mean participant age was 10 years 11 months (SD 4y 2mo, range 5-18y). There were 44 males and 31 females and 37 (49%) had predominant dyskinetic CP. Pain was prevalent in 85% and it was chronic in 77% of participants. Fifty-two per cent experienced moderate-to-high carer-reported pain intensity, which was significantly associated with predominant dyskinetic motor types (p=0.008). Pain occurred at multiple body locations (5 out of 21), with significantly increased numbers of locations at higher Gross Motor Function Classification System levels (p=0.02). Face, jaw, and temple pain was significantly associated with predominant dyskinetic motor types (p=0.005). Poorer carer proxy-reported quality of life was detected in those with chronic pain compared to those without (p=0.03); however, chronic pain did not affect quality of life for self-reporting participants.Interpretation: Pain was highly prevalent in children and adolescents with predominant dyskinetic and mixed (dyskinetic/spastic) motor types, highlighting a population in need of lifespan pain management.What This Paper Adds: Chronic pain prevalence in children and adolescents with predominant dyskinetic and mixed (dyskinetic/spastic) motor types is high. Pain occurs across multiple body locations in predominant dyskinetic and mixed (dyskinetic/spastic) motor types. Less recognized locations of pain include the face, jaw, and temple for predominant dyskinetic motor types. [ABSTRACT FROM AUTHOR]

Aim: To analyse the development of motor skill and executive function in school-aged children with and without developmental coordination disorder (DCD).Method: Using a longitudinal design, 186 children (86 males, 100 females) aged 6 to 11 years at Time 1 were tested over a 2-year period, 52 of whom were diagnosed with DCD at Time 1 (27 males, 25 females; mean age 8y 5mo, SD 1y 6mo) using DSM-5 criteria. The McCarron Assessment of Neuromuscular Development assessed motor status at Time 1 and at 2-year follow-up (Time 2). Executive function was assessed using a well-validated measure, the Groton Maze Learning Test.Results: The DCD cohort at Time 1 had moderate incidence of executive function deficit (41%). Most importantly, at a group level, children with persisting DCD (across Times 1 and 2) also showed significantly lower levels of executive function than children with typical motor development at both time points. At an individual level, around 26% of children in this group had persisting executive function deficits relative to normal ranges of performance.Interpretation: Children with persisting DCD are at significant risk of executive function issues. The combination of motor and cognitive issues as a potential risk factor in the longer-term development of children is discussed.What This Paper Adds: Around half of children initially diagnosed with developmental coordination disorder (DCD) had the same diagnosis at 2-year follow-up. 41% of children with DCD have impaired executive function. Children with persisting DCD show poorer executive function than those with typical motor development or remitting DCD. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the properties of the Infant Motor Activity Log (IMAL), a caregiver-report for frequency and quality of use of more affected upper extremity in infants with neurological and functional impairments.Method: This was a prospective cohort study of 66 children (34 females, 32 males) aged 6 to 24 months (mean age [SD] 13.7mo [5.3]) with neurological and functional impairments and a confirmed cerebral palsy diagnoses after 2 years, and 51 age-matched typically developing children. The IMAL was administered at baseline and 4 weeks later. Typically developing infants were tested with randomly assigned 'more affected' upper extremity. Psychometric properties were evaluated using Spearman's correlation coefficient, Cronbach's alpha, and Jonckheere-Terpstra tests.Results: In the children with impairments, the IMAL showed internal consistency (alpha≥0.88) for the How Well Scale (HWS) and How Often Scale (HOS). Test-retest reliability was 0.64 (HOS) and 0.70 (HWS), demonstrating stability over time. Correlation with Bayley Scales of Infant and Toddler Development, Third Edition more affected arm raw scores were 0.70 (HOS) and 0.72 (HWS) (p<0.001) demonstrating construct validity. Both scale scores decreased with increasing Gross Motor Function Classification System and Mini-Manual Ability Classification System (p<0.001) levels, supporting discriminative validity. Discrimination between typically developing infants and infants with impairments was high (HWS: area under the receiver operating characteristic curve [AUC] 0.96, 95% confidence interval [CI] 0.94-0.99 and HOS AUC=0.95, CI 0.92-0.99).Interpretation: The IMAL is a valid and reliable discriminative caregiver measure of upper limb performance and may complement measures of capacity in infants with neurological and functional impairments.What This Paper Adds: The Infant Motor Activity Log (IMAL) is a valid and reliable measure of caregiver perception of upper limb function. The IMAL fills a measurement gap for infant motor performance in children with impairments. The IMAL discriminates among motor function levels. [ABSTRACT FROM AUTHOR]

Aim: To examine the efficacy of Hand-Arm Bimanual Intensive Therapy (HABIT) on daily functioning, unimanual dexterity, and bimanual performance of children with bilateral cerebral palsy (CP) compared with customary care.Method: Forty-one children with bilateral CP, aged 4 to 16 years, classified in levels I to III of the Manual Ability Classification System, were randomly assigned to HABIT (90h) (n=21) or to customary care (4.5h) (n=20). Participants' daily functioning (Pediatric Evaluation of Disability Inventory [PEDI], Canadian Occupational Performance Measure [COPM]), unimanual dexterity (Jebsen-Taylor Test of Hand Function, Box and Blocks Test [BBT]), and bimanual performance (Both Hands Assessment) were assessed pre-, post-, and 6 months after the intervention. Linear mixed-effects models were used for inferential analysis.Results: Children participating in HABIT showed greater improvements in daily functioning (COPMperformance : χ12 =9.50, p<0.01; COPMsatisfaction : χ12 =5.07, p<0.05; PEDIfunctional skills : χ12 =6.81, p<0.01; PEDIcaregiver assistance : χ12 =6.23, p<0.05) and in the dexterity of the dominant hand (BBT: χ12 =3.99, p<0.05) compared with children maintaining customary care. Group or time effects did not explain any variance in bimanual performance or in the dexterity of the non-dominant hand.Interpretation: HABIT may be beneficial for children with bilateral CP, with benefits evidenced for daily functioning outcomes.What This Paper Adds: Hand-Arm Bimanual Intensive Therapy (HABIT) improved daily functioning of children with bilateral cerebral palsy (CP). Bimanual performance, measured by the Both Hands Assessment, did not change after HABIT in children with bilateral CP. Children with asymmetric and symmetric hand use exhibited similar improvements after HABIT. [ABSTRACT FROM AUTHOR]

Variants in the gene SCN1A are a common genetic cause for a wide range of epilepsy phenotypes ranging from febrile seizures to Dravet syndrome. Focal onset seizures and structural lesions can be present in these patients and the question arises whether epilepsy surgery should be considered. We report eight patients (mean age 13y 11mo [SD 8y 1mo], range 3-26y; four females, four males) with SCN1A variants, who underwent epilepsy surgery. Outcomes were variable and seemed to be directly related to the patient's anatomo-electroclinical epilepsy phenotype. Patients with Dravet syndrome had unfavourable outcomes, whilst patients with focal epilepsy, proven to arise from a single structural lesion, had good results. We conclude that the value of epilepsy surgery in patients with an SCN1A variant rests on two issues: understanding whether the variant is pathogenic and the patient's anatomo-electroclinical phenotype. Careful evaluation of epilepsy phenotype integrated with understanding the significance of genetic variants is essential in determining a patient's suitability for epilepsy surgery. Patients with focal onset epilepsy may benefit from epilepsy surgery, whereas those with Dravet syndrome do not. WHAT THIS PAPER ADDS: Patients should not automatically be excluded from epilepsy surgery evaluation if they carry an SCN1A variant. Patients with focal epilepsy may benefit from epilepsy surgery; those with Dravet syndrome do not. [ABSTRACT FROM AUTHOR]

Introduction: Induction of labor (IOL) is used to improve the outcome of pregnancy for mother and child. Since 2013, oral misoprostol has been used for IOL at Aarhus University Hospital, Denmark. The purpose of the present paper is to describe our experience of the use of a new, 25-µg misoprostol tablet commercially manufactured for the purpose of IOL regarding efficacy and outcome for mother and neonate in both an inpatient and an outpatient regimen.Material and Methods: We performed an audit from 1 April 2016, including data on all IOL in women with singleton pregnancies until 1000 consecutive women were registered. Data from 976 consecutive women with gestational age ≥37+0  weeks induced in accordance with the "Aarhus protocol" were included in the present analyses. All inductions were by oral misoprostol. Outpatient induction is standard procedure in low-risk pregnancies, that is, pregnancies with a healthy mother and no signs of placental insufficiency. In the outpatient IOL, the first dose of misoprostol is administered after a normal cardiotocography registration at the hospital. Subsequent doses are taken at home according to a predefined regimen. Following delivery, data on baseline variables and outcome variables for the mother and neonate were retrieved from the medical records.Results: In 71.9% of cases, the women were induced in an outpatient regimen. Delivery within 24 hours was achieved in 38.8% of women (nulliparous 32.3%, multiparous 50.9%) and within 48 hours in 70.1% (nulliparous 66.2%, multiparous 77.2%). Hyperstimulation during induction occurred in 0.6%. The mode of delivery was spontaneous vaginal in 75.5% of cases. The cesarean section rate was 14.9% (nulliparous 20.7%, multiparous 4.1%). Apgar <7 at 5 minutes and pH <7.0 in the umbilical artery was seen in 0.9% and 0.7%, respectively.Conclusions: Induction of labor by a commercially produced low-dose (25 µg) misoprostol tablet for oral induction according to the "Aarhus protocol" is feasible in an outpatient as well as an inpatient regimen. Delivery was achieved within 48 hours for 70.1% of women. Few adverse events were seen; however, the audit was underpowered for safety. [ABSTRACT FROM AUTHOR]

In healthcare settings, there is an emotional cost to caring which can result in compassion fatigue, burnout, secondary trauma, and compromised patient care. Innovative workplace interventions such as the Schwartz Rounds offer a group reflective practice forum for clinical and non‐clinical professionals to reflect on the emotional aspects of working in health care. Whilst the Rounds are established in medical health practice, this study presents an evaluation of the Rounds offered to mental health services. The Rounds were piloted amongst 150 mental health professionals for 6 months and evaluated using a mixed‐methods approach with standardized evaluation forms completed after each Round and a focus group (n = 9) at one‐month follow‐up. This paper also offers a unique six‐year follow‐up of the evaluation of the Rounds. Rounds were rated as helpful, insightful, and relevant, and at six years follow‐up, Rounds were still rated as valuable and viewed as embedded. Focus groups indicated that Rounds were valued because of the opportunity to express emotions (in particular negative emotions towards patients that conflict with the professional care‐role), share experiences, and feel validated and supported by colleagues. The findings indicate that Schwartz Rounds offer a positive application in mental healthcare settings. The study supports the use of interventions which provide an ongoing forum in which to discuss emotions, develop emotional literacy, provide peer support and set an intention for becoming a more compassionate organization in which to work. [ABSTRACT FROM AUTHOR]

Aim: To describe trends in gastrostomy tube insertion in children with developmental or acquired disorders in Sweden and assess their demographic characteristics.Method: Children aged 0 to 18 years with gastrostomy tube insertions recorded between 1998 and 2014 were identified in the Swedish National Patient Register. Associations between disorder type and year of surgery, as well as age at surgery, were analysed using linear regression analyses. The association between disorder type and mortality 2 years from gastrostomy tube insertion was also analysed using logistic regression analysis.Results: The data for 4112 children (2182 males, 1930 females), with a median age of 2 years (interquartile range=1-8y), were analysed. Children who presented with developmental disorders were the largest group (n=3501, 85%). The most common diagnosis in children with developmental disorders was cerebral palsy (n=165, 4%). In children with acquired disorders, acute lymphoblastic leukaemia (n=117, 3%) was the most common diagnosis. Gastrostomy tube insertions increased from 1998 to 2014, with the greatest increase in children with developmental disorders, who were younger than children with acquired disorders when the gastrostomy tube was first inserted. Age at tube insertion decreased in both groups during the study period. Mortality was higher in children with acquired disorders, suggesting that gastrostomy tube insertion should be part of a palliative care approach.Interpretation: Child characteristics differed depending on whether the underlying disorder was developmental or acquired, suggesting a need for clinical health care guidelines related to the specific goals of gastrostomy tube insertion.What This Paper Adds: Gastrostomy tube insertions increased by 140% from 1998 to 2014 in Sweden. The age of children with developmental disorders decreased by 1 month per year during the study period. Children presenting with developmental disorders were younger than children with acquired disorders when the gastrostomy tube was first inserted. Mortality was higher in children with acquired disorders. [ABSTRACT FROM AUTHOR]

Aim: To explore whether increasing parental education has a causal effect on risk of cerebral palsy (CP) in the child, or whether unobserved confounding is a more likely explanation.Method: We used data from Norwegian registries on approximately 1.5 million children born between 1967 and 2011. We compared results from a traditional cohort design with results from a family-based matched case-control design, in which children with CP were matched to their first cousins without CP. In addition, we performed a simulation study to assess the role of unobserved confounding.Results: In the cohort design, the odds of CP were reduced in children of mothers and fathers with higher education (adjusted odds ratio [OR] 0.67, 95% confidence interval [CI] 0.60-0.75 for maternal education, and adjusted OR 0.75, 95% CI 0.67-0.85 for paternal education). In the family-based case-control design, only an association for maternal education remained (adjusted OR 0.80, 95% CI 0.64-0.99). Results from a simulation study suggested that this association could be explained by unobserved confounding.Interpretation: A causal effect of obtaining higher education on risk of CP in the child is unlikely. Results stress the importance of continued research on the role of genetic and environmental risk factors that vary by parents' educational level.What This Paper Adds: Children of higher-educated parents had significantly lower odds of cerebral palsy (CP). There was no evidence of difference in risk of CP within first cousins whose mothers or fathers had different educational levels. Association between parental education and odds of CP did not reflect a causal effect. [ABSTRACT FROM AUTHOR]

Psychiatric genetic research investigates the genetic basis of psychiatric disorders with the aim of more effectively understanding, treating, or, ultimately, preventing such disorders. Given the challenges of recruiting research participants into such studies, the potential for long-term benefits of such research, and seemingly minimal risk, a strong claim could be made that all non-acute psychiatric inpatients, including forensic and involuntary patients, should be included in such research, provided they have capacity to consent. There are tensions, however, regarding the ethics of recruiting psychiatric inpatients into such studies. In this paper our intention is to elucidate the source of these tensions from the perspective of research ethics committee interests and decision-making. We begin by defining inpatient status and outline some of the assumptions surrounding the structures of inpatient care. We then introduce contemporary conceptions of vulnerability, including Florencia Luna's account of vulnerability which we use as a framework for our analysis. While psychiatric inpatients could be subject to consent-related vulnerabilities, we suggest that a particular kind of exploitation-related vulnerability comes to the fore in the context of our case study. Moreover, a subset of these ethical concerns takes on particular weight in the context of genetic research in low- and middle-income countries. At the same time, the automatic exclusion of inpatients from research elicits justice-related vulnerabilities. [ABSTRACT FROM AUTHOR]