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Introduction: Short-form versions of the Montreal Cognitive Assessment (SF-MoCA) are increasingly used to screen for dementia in research and practice. We sought to collate evidence on the accuracy of SF-MoCAs and to externally validate these assessment tools.Methods: We performed systematic literature searching across multidisciplinary electronic literature databases, collating information on the content and accuracy of all published SF-MoCAs. We then validated all the SF-MoCAs against clinical diagnosis using independent stroke (n = 787) and memory clinic (n = 410) data sets.Results: We identified 13 different SF-MoCAs (21 studies, n = 6477 participants) with differing test content and properties. There was a pattern of high sensitivity across the range of SF-MoCA tests. In the published literature, for detection of post stroke cognitive impairment, median sensitivity across included studies: 0.88 (range: 0.70-1.00); specificity: 0.70 (0.39-0.92). In our independent validation using stroke data, median sensitivity: 0.99 (0.80-1.00); specificity: 0.40 (0.14-0.87). To detect dementia in older adults, median sensitivity: 0.88 (0.62-0.98); median specificity: 0.87 (0.07-0.98) in the literature and median sensitivity: 0.96 (range: 0.72-1.00); median specificity: 0.36 (0.14-0.86) in our validation. Horton's SF-MoCA (delayed recall, serial subtraction, and orientation) had the most favorable properties in stroke (sensitivity: 0.90, specificity: 0.87, positive predictive value [PPV]: 0.55, and negative predictive value [NPV]: 0.93), whereas Cecato's "MoCA reduced" (clock draw, animal naming, delayed recall, and orientation) performed better in the memory clinic (sensitivity: 0.72, specificity: 0.86, PPV: 0.55, and NPV: 0.93).Conclusions: There are many published SF-MoCAs. Clinicians and researchers using a SF-MoCA should be explicit about the content. For all SF-MoCA, sensitivity is high and similar to the full scale suggesting potential utility as an initial cognitive screening tool. However, choice of SF-MoCA should be informed by the clinical population to be studied. [ABSTRACT FROM AUTHOR]

Objective: Slowing functional decline could enable people living with dementia to live for longer and more independently in their own homes. We aimed to update previous syntheses examining the effectiveness of nonpharmacological interventions in reducing functional decline (activities of daily living, activity-specific physical functioning, or function-specific goal attainment) in people living in their own homes with dementia.Methods: We systematically searched electronic databases from January 2012 to May 2018; two researchers independently rated risk of bias of randomised controlled trials (RCTs) fitting predetermined inclusion criteria using a checklist; we narratively synthesised findings, prioritising studies judged to have a lower risk of bias.Results: Twenty-nine papers (describing 26 RCTs) met eligibility criteria, of which we judged 13 RCTs to have a lower risk of bias. Study interventions were evaluated in four groups: physical exercise, occupational, multicomponent, and cognition-oriented interventions. Four out of 13 RCTs reported functional ability as a primary outcome. In studies judged to have a lower risk of bias, in-home tailored exercise, individualised cognitive rehabilitation, and in-home activities-focussed occupational therapy significantly reduced functional decline relative to control groups in individual studies. There was consistent evidence from studies at low risk of bias that group-based exercise and reminiscence therapies were ineffective at reducing functional decline.Conclusion: We found no replicated evidence of intervention effectiveness in decreasing functional decline. Interventions associated with slower functional decline in individual trials have been individually delivered and tailored to the needs of the person with dementia. This is consistent with previous findings. Future intervention trials should prioritise these approaches. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: The incidence of a peri-implant soft tissue dehiscence/deficiency (PSTD) is not a rare finding. Despite multiple previous attempts aimed at correcting the PSTDs, a classification of these conditions has not yet been proposed. This lack in the literature may also lead to discrepancies in the reported treatment outcomes and thus misinform the clinician or the readers. The aim of the present article was therefore to present a classification of peri-implant PSTD at a single implant site.Methods: Four classes of PSTDs were discussed based on the position of the gingival margin of the implant-supported crown in relation to the homologous natural tooth. In addition, the bucco-lingual position of the implant head was also taken into consideration. Each class was further subdivided based on the height of the anatomical papillae.Results: Subsequently, for each respective category a surgical approach (including bilaminar techniques, the combined prosthetic-surgical approach or soft tissue augmentation with a submerged healing) was also suggested.Conclusion: This paper provides a new classification system for describing PSTDs at single implant sites, with the appropriate recommended treatment protocol. [ABSTRACT FROM AUTHOR]

Abstract: This paper aims to highlight the importance of aspiring to achieve universal reporting of maternal deaths as a part of taking responsibility for these avoidable tragedies. The paper first discusses the reasons for reporting maternal deaths, distinguishing between individual case notification and aggregate statistics. This is followed by a summary of the status of reporting at national and international levels, as well as major barriers and facilitators to this process. A new framework is then proposed — the REPORT framework, designed to highlight six factors essential to universal reporting. Malaysia is used to illustrate the relevance of these factors. Finally, the paper makes a Call to Action by FIGO to promote REPORT and to encourage health professionals to play their part in improving the quality of reporting on all maternal deaths — not just those directly in their care. [Copyright &y& Elsevier]

Purpose: This paper focuses attention on declining rates of instrumental (vacuum or forceps) delivery. The decline often means that women must travel further to deliver in hospitals with capacity for cesarean delivery.Background: The paper illustrates recent trends in the use of vacuum extraction and forceps in low- and high-income countries. It describes some of the obstacles to the use of instrumental delivery and why the techniques, especially vacuum extraction, should be reintroduced. Over the past two decades, many countries have observed a decline in instrumental delivery rates while cesarean rates have increased. Objections to instrumental delivery are largely due to the potential harm it causes newborns. Some medical schools no longer train their professionals to perform instrumental delivery. Elsewhere, only specialists are permitted to perform the procedures.Methods and Results: As this is a policy paper rather than a research report, the methods and results sections are not applicable.Conclusions: Vacuum extraction can be taught to midlevel practitioners (midwives, nurse practitioners and general physicians), thereby increasing access to emergency obstetric care especially at the periphery. This allows women to give birth closer to home in midlevel facilities when hospitals are not easily accessible or are overcrowded. Where instrumental and cesarean delivery are both available, instrumental delivery could potentially reduce the risks associated with cesarean delivery and reduce the costs of obstetric care. [ABSTRACT FROM AUTHOR]

Many countries produce data on the prevalence and duration of breastfeeding, but are they reliable? We reviewed 16 studies on breastfeeding in Italy published after 1990. They report a prevalence of breastfeeding at and around birth ranging from 66% to 91%, decreasing to 17-52% at 4 mo and 28-36% at 6 mo. Most studies refer to a non-representative sample of the Italian population. Two studies used standard definitions of breastfeeding, but their results are difficult to interpret or cannot be generalized. Five other studies used non-standard definitions that undermine the interpretation of results. The remaining nine studies used no definition at all. All studies used a recall period different from 24 h, or from the whole hospital stay for breastfeeding at discharge, making the interpretation of results even more difficult. We conclude that the published information gives an inaccurate picture of the prevalence and duration of breastfeeding in Italy, leading to unjustified optimism and inaction. The actual figures may be lower, as shown by preliminary data from a small Italian region: using standard definitions and methods during a 9-mo monitoring period, exclusive breastfeeding averaged 35% at discharge and 23% at about 4 mo of age. [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]

In this paper, we present a unified modeling framework to combine aggregated data from randomized controlled trials (RCTs) with individual participant data (IPD) from observational studies. Rather than simply pooling the available evidence into an overall treatment effect, adjusted for potential confounding, the intention of this work is to explore treatment effects in specific patient populations reflected by the IPD. In this way, by collecting IPD, we can potentially gain new insights from RCTs' results, which cannot be seen using only a meta-analysis of RCTs. We present a new Bayesian hierarchical meta-regression model, which combines submodels, representing different types of data into a coherent analysis. Predictors of baseline risk are estimated from the individual data. Simultaneously, a bivariate random effects distribution of baseline risk and treatment effects is estimated from the combined individual and aggregate data. Therefore, given a subgroup of interest, the estimated treatment effect can be calculated through its correlation with baseline risk. We highlight different types of model parameters: those that are the focus of inference (e.g., treatment effect in a subgroup of patients) and those that are used to adjust for biases introduced by data collection processes (e.g., internal or external validity). The model is applied to a case study where RCTs' results, investigating efficacy in the treatment of diabetic foot problems, are extrapolated to groups of patients treated in medical routine and who were enrolled in a prospective cohort study. [ABSTRACT FROM AUTHOR]

Issue addressed Alcohol-related road crashes are a leading cause of the injury burden experienced by Indigenous Australians. Existing drink driving programs are primarily designed for the mainstream population. The 'Hero to Healing' program was specifically developed with Indigenous communities and is underpinned by the Community Reinforcement Approach (CRA). This paper reports on the formative evaluation of the program from delivery in two Far North Queensland communities. Methods Focus groups and semistructured interviews were conducted with drink driver participants (n=17) and other Elders and community members (n=8) after each program. Qualitative content analysis was used to categorise the transcripts. Results The CRA appealed to participants because of its flexible nature and encouragement of rearranging lifestyle factors, without specific focus on alcohol use. Participants readily identified with the social and peer-related risk and protective factors discussed. Cofacilitation of the program with Elders was identified as a key aspect of the program. More in-depth discussion about cannabis and driving, anger management skills and relationship issues are recommended. Conclusions Participants' recognition of content reinforced earlier project results, particularly the use of kinship pressure to motivate younger family members to drink drive. Study findings suggest that the principles of the CRA are useful; however, some amendments to the CRA components and program content were necessary. So what? Treating drink driving in regional and remote Indigenous Australian communities as a community and social issue, rather than an individual phenomenon, is likely to lead to a reduction in the number of road-related injuries Indigenous people experience. [ABSTRACT FROM AUTHOR]

Objective: The 10/36 Spatial Recall Test is a measure of visuospatial memory and has been recommended for inclusion when administering a brief cognitive assessment to patients with multiple sclerosis by multiple groups. However, a notable limitation of the measure includes a lack of normative data with demographic corrections. Thus, the primary objective of the current study was to examine demographic influences on the 10/36 Spatial Recall Test and to introduce demographically corrected normative data for the instrument.Methods: Data were collected from 116 participants over the age of 50 years. All study participants were free of any neurologic disease or disorder and classified as cognitively intact by a consensus conference team that was comprised of neurologists and neuropsychologists. All study participants were administered a neuropsychological evaluation that included the 10/36 Spatial Recall Test Version A at the baseline visit.Results: 10/36 Spatial Recall Test scores were affected by age, education, and race. Gender effects were not observed. Given these effects, regression equations were used to correct for the effects of demographic variables. The z-scores obtained from these corrections were not significantly influenced by demographical variables.Conclusion: The demographic corrections introduced in this paper offer the possibility to enhance the clinical utility of the 10/36 Spatial Recall Test. [ABSTRACT FROM AUTHOR]

How health care providers are paid affects how medicine is practiced. It is thus important to assess provider payment models not only from the economic perspective but also from the ethical perspective. China recently started to reform the provider payment model in the health care system from fee-for-service to case-based payment. This paper aims to examine this transition from an ethical perspective. We collected empirical studies on the impact of case-based payment in the Chinese health care system and applied a systematic ethical matrix that integrates clinical ethics and public health ethics to analyze the empirical findings. We identified eleven prominent ethical issues related to case-based payment. Some ethical problems of case-based payment in China are comparable to ethical problems of managed care and diagnosis related groups in high-income countries. However, in this paper we discuss in greater detail four specific ethical issues in the Chinese context: professionalism, the patient-physician relationship, access to care and patient autonomy. Based on the analysis, we cautiously infer that case-based payment is currently more ethically acceptable than fee-for-service in the context of China, mainly because it seems to lower financial barriers to access care. Nonetheless, it will be difficult to justify the implementation of case-based payment if no additional measures are taken to monitor and minimize its existing negative ethical implications. [ABSTRACT FROM AUTHOR]

In this paper, we derive the joint distribution of progression-free and overall survival as a function of transition probabilities in a multistate model. No assumptions on copulae or latent event times are needed and the model is allowed to be non-Markov. From the joint distribution, statistics of interest can then be computed. As an example, we provide closed formulas and statistical inference for Pearson's correlation coefficient between progression-free and overall survival in a parametric framework. The example is inspired by recent approaches to quantify the dependence between progression-free survival, a common primary outcome in Phase 3 trials in oncology and overall survival. We complement these approaches by providing methods of statistical inference while at the same time working within a much more parsimonious modeling framework. Our approach is completely general and can be applied to other measures of dependence. We also discuss extensions to nonparametric inference. Our analytical results are illustrated using a large randomized clinical trial in breast cancer. [ABSTRACT FROM AUTHOR]

Analyzing safety data from clinical trials to detect safety signals worth further examination involves testing multiple hypotheses, one for each observed adverse event (AE) type. There exists certain hierarchical structure for these hypotheses due to the classification of the AEs into system organ classes, and these AEs are also likely correlated. Many approaches have been proposed to identify safety signals under the multiple testing framework and tried to achieve control of false discovery rate (FDR). The FDR control concerns the expectation of the false discovery proportion (FDP). In practice, the control of the actual random variable FDP could be more relevant and has recently drawn much attention. In this paper, we proposed a two-stage procedure for safety signal detection with direct control of FDP, through a permutation-based approach for screening groups of AEs and a permutation-based approach of constructing simultaneous upper bounds for false discovery proportion. Our simulation studies showed that this new approach has controlled FDP. We demonstrate our approach using data sets derived from a drug clinical trial. [ABSTRACT FROM AUTHOR]

When several types of recurrent events may arise, interest often lies in marginal modeling and studying the nature of the dependence structure. In this paper, we propose a multivariate mixed-Poisson model with the dependence between events accommodated by type-specific random effects which are associated through use of a Gaussian copula. Such models retain marginal features with a simple interpretation, reflect the heterogeneity in risk for each type of event, and provide insight into the dependence between the different types of events. Semiparametric inference is proposed based on composite likelihood to avoid high dimensional integration. An application to a study of nutritional supplements in malnourished children is given in which the goal is to evaluate the reduction in the rate of several different kinds of infection. [ABSTRACT FROM AUTHOR]

Bayesian adaptive designs have become popular because of the possibility of increasing the number of patients treated with more beneficial treatments, while still providing sufficient evidence for treatment efficacy comparisons. It can be essential, for regulatory and other purposes, to conduct frequentist analyses both before and after a Bayesian adaptive trial, and these remain challenging. In this paper, we propose a general simulation-based approach to compare frequentist designs with Bayesian adaptive designs based on frequentist criteria such as power and to compute valid frequentist p-values. We illustrate our approach by comparing the power of an equal randomization (ER) design with that of an optimal Bayesian adaptive (OBA) design. The Bayesian design considered here is the dynamic programming solution of the optimization of a specific utility function defined by the number of successes in a patient horizon, including patients whose treatment will be affected by the trial's results after the end of the trial. While the power of an ER design depends on treatment efficacy and the sample size, the power of the OBA design also depends on the patient horizon size. Our results quantify the trade-off between power and the optimal assignment of patients to treatments within the trial. We show that, for large patient horizons, the two criteria are in agreement, while for small horizons, differences can be substantial. This has implications for precision medicine, where patient horizons are decreasing as a result of increasing stratification of patients into subpopulations defined by molecular markers. [ABSTRACT FROM AUTHOR]

Wearable device technology allows continuous monitoring of biological markers and thereby enables study of time-dependent relationships. For example, in this paper, we are interested in the impact of daily energy expenditure over a period of time on subsequent progression toward obesity among children. Data from these devices appear as either sparsely or densely observed functional data and methods of functional regression are often used for their statistical analyses. We study the scalar-on-function regression model with imprecisely measured values of the predictor function. In this setting, we have a scalar-valued response and a function-valued covariate that are both collected at a single time period. We propose a generalized method of moments-based approach for estimation, while an instrumental variable belonging in the same time space as the imprecisely measured covariate is used for model identification. Additionally, no distributional assumptions regarding the measurement errors are assumed, while complex covariance structures are allowed for the measurement errors in the implementation of our proposed methods. We demonstrate that our proposed estimator is L2 consistent and enjoys the optimal rate of convergence for univariate nonparametric functions. In a simulation study, we illustrate that ignoring measurement error leads to biased estimations of the functional coefficient. The simulation studies also confirm our ability to consistently estimate the function-valued coefficient when compared to approaches that ignore potential measurement errors. Our proposed methods are applied to our motivating example to assess the impact of baseline levels of energy expenditure on body mass index among elementary school-aged children. [ABSTRACT FROM AUTHOR]

The literature on causal effect estimation tends to focus on the population mean estimand, which is less informative as medical treatments are becoming more personalized and there is increasing awareness that subpopulations of individuals may experience a group-specific effect that differs from the population average. In fact, it is possible that there is underlying systematic effect heterogeneity that is obscured by focusing on the population mean estimand. In this context, understanding which covariates contribute to this treatment effect heterogeneity (TEH) and how these covariates determine the differential treatment effect (TE) is an important consideration. Towards such an understanding, this paper briefly reviews three approaches used in making causal inferences and conducts a simulation study to compare these approaches according to their performance in an exploratory evaluation of TEH when the heterogeneous subgroups are not known a priori. Performance metrics include the detection of any heterogeneity, the identification and characterization of heterogeneous subgroups, and unconfounded estimation of the TE within subgroups. The methods are then deployed in a comparative effectiveness evaluation of drug-eluting versus bare-metal stents among 54 099 Medicare beneficiaries in the continental United States admitted to a hospital with acute myocardial infarction in 2008. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Though there is a burgeoning interest in applied Buddhist ethics, Buddhist animal research ethics remains an underdeveloped area. In this paper I will explore how some central Buddhist ethical considerations can usefully engage our use of other animals (henceforth, animals) in science. As the scientific use of animals is broad, I will narrow my focus to laboratory science. I will show that, though a Buddhist abolitionism would not be unmotivated, it is possible to reject it. While doing so, it will be important to resist emphasizing elements of Buddhist thought that merely provide reasons to adopt the dominant ethical framework governing laboratory animal research ethics, known as the 3Rs. Though I will suggest how a Buddhist animal research ethics can sometimes permit the use of animals in harmful research, it will also require ethical constraints that resonate with some of the more progressive elements in 'Western' bioethics. [ABSTRACT FROM AUTHOR]

Community engagement in research, including public health related research, is acknowledged as an ethical imperative. While medical care and public health action take priority over research during infectious disease outbreaks, research is still required in order to learn from epidemic responses. The World Health Organisation developed a guide for community engagement during infectious disease epidemics called the Good Participatory Practice for Trials of Emerging (and Re-emerging) Pathogens that are Likely to Cause Severe Outbreaks in the Near Future and for which Few or No Medical Counter-Measures Exist (GPP-EP). This paper identified priorities for community engagement for research conducted during infectious disease outbreaks drawing on discussions held with a purposive sample of bioethicists, social scientists, researchers, policy makers and laypersons who work with ethics committees in West Africa. These perspectives were considered in the light of the GPP-EP, which adds further depth and dimension to discussions on community engagement frameworks. It concludes that there is no presumptive justification for the exclusion of communities in the design, implementation and monitoring of clinical trials conducted during an infectious disease outbreak. Engagement that facilitates collaboration rather than partnership between researchers and the community during epidemics is acceptable. [ABSTRACT FROM AUTHOR]

"Vulnerability" is a key concept for research ethics and public health ethics. This term can be discussed from either a conceptual or a practical perspective. I previously proposed the metaphor of layers to understand how this concept functions from the conceptual perspective in human research. In this paper I will clarify how my analysis includes other definitions of vulnerability. Then, I will take the practical-ethical perspective, rejecting the usefulness of taxonomies to analyze vulnerabilities. My proposal specifies two steps and provides a procedural guide to help rank layers. I introduce the notion of cascade vulnerability and outline the dispositional nature of layers of vulnerability to underscore the importance of identifying their stimulus condition. In addition, I identify three kinds of obligations and some strategies to implement them. This strategy outlines the normative force of harmful layers of vulnerability. It offers concrete guidance. It contributes substantial content to the practical sphere but it does not simplify or idealize research subjects, research context or public health challenges. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: The Anaesthesia PRactice In Children Observational Trial (APRICOT) in 261 European hospitals revealed a 5.2% incidence of severe critical events in the perioperative period and wide variability in practice.Methods: A sub-analysis of the Scandinavian data was undertaken to investigate differences from the rest of Europe in the incidence and nature of perioperative severe critical events and to attempt to identify areas for quality improvement.Findings: In the Scandinavian cohorts of 1520 paediatric patients out of 31 127 patients, the overall incidence of perioperative severe critical events was lower than the rest of Europe (4.4% (95% CI [3.5-5.6]) vs 5.2% (95% CI [5.0-5.5]); RR 0.57), albeit the incidence varied across countries. There was a lower rate of bronchospasm (0.9%), stridor (1.1%) and cardiovascular instability (0.9%) than the rest of Europe. The proportion of bronchospasm events occurring at induction was 0.13% in Scandinavian cohort which was less than the rest of Europe (1.2%). The proportion of sicker patients where less experienced teams were managing the care was notably lower in Scandinavia than in the rest of Europe (14.4% vs 20.4% of the American Society of Anesthesiologists Physical Status Classification System Score (ASA-PS III and 8.3% vs 12.8% of the ASA-PS IV. Cardiovascular instability was lower in Scandinavia (0.92%) compared to Europe (1.9%). The incidence of drug errors was low in both the overall APRICOT (0.2%) and in Scandinavia (0.3%). There were no deaths.Interpretation: This sub-analysis shows that current Scandinavia paediatric perioperative clinical practice compares favourably with the rest of Europe. The lower incidence of cardiovascular and respiratory complications could be partly attributed to more experienced dedicated paediatric anaesthesia providers managing the higher risk groups of patients in Scandinavia. Whether this cohort of anaesthetized children is truly representative of the entire Scandinavia countries is unknown. Areas for quality improvement include: standardisation of the definition of severe critical events, increased reporting, development of evidence-based protocols for the management of severe critical events, development and rational implementation of paediatric perioperative risk assessment scores, implementation of current best practice in the provision of competent paediatric anaesthesia service in Europe, development of specific training and ensuring maintenance skills in paediatric anaesthesia. Furthermore, based on data from the original Apricot paper children under the age of 3 years and ASA-PS III and IV patients should not be anaesthetised without direct supervision of a specialist in paediatric anaesthesia. Given the sample size of the Scandinavian cohort this conclusion cannot be investigated further. [ABSTRACT FROM AUTHOR]

Economic evaluations from individual-level data are an important component of the process of technology appraisal, with a view to informing resource allocation decisions. A critical problem in these analyses is that both effectiveness and cost data typically present some complexity (eg, nonnormality, spikes, and missingness) that should be addressed using appropriate methods. However, in routine analyses, standardised approaches are typically used, possibly leading to biassed inferences. We present a general Bayesian framework that can handle the complexity. We show the benefits of using our approach with a motivating example, the MenSS trial, for which there are spikes at one in the effectiveness and missingness in both outcomes. We contrast a set of increasingly complex models and perform sensitivity analysis to assess the robustness of the conclusions to a range of plausible missingness assumptions. We demonstrate the flexibility of our approach with a second example, the PBS trial, and extend the framework to accommodate the characteristics of the data in this study. This paper highlights the importance of adopting a comprehensive modelling approach to economic evaluations and the strategic advantages of building these complex models within a Bayesian framework. [ABSTRACT FROM AUTHOR]

Background: Many neonatal observational pain assessment tools are available. Their application in clinical settings, however, has been limited. A further difficulty for decision makers may be to choose among the variety of available tools the appropriate one(s) for their patients. Aims of the present study were (1) to compare two commonly cited neonatal pain assessment tools, the Neonatal Facial Coding System-Revised (NFCS-R) and the Children and Infant's Postoperative Pain Scale (CHIPPS), with regard to their psychometric qualities and (2) to explore intuitive clinicians' ratings by relating them to the tools' items.Methods: Three coders applied both pain assessment tools to videos of 44 neonates who were videotaped while undergoing a painful and a stressful procedure. Clinicians rated the pain neonates experienced on a numerical rating scale. Analyses of variances and regression analyses were used to investigate whether tools could discriminate between the procedures and whether tools' items were predictors of intuitive clinicians' ratings.Results: Interrater reliability, internal consistency and relative convergent validity were high for both assessment tools. Both tools discriminated between painful and stressful situations equally well. Roughly one third of variance in clinicians' intuitive ratings could be explained by items of each tool, however, no single item was found to be a significant predictor.Conclusions: Both pain assessment tools performed equally well regarding psychometric comparisons. Therefore, clinical utility needs to be considered when having to choose. Possibilities of improvement for both tools were identified. Cues clinicians base their intuitive pain judgements need to be further investigated.Significance: Psychometric comparisons of neonatal assessment tools provide useful information that can help health care professionals to choose among tools and researchers to improve them. Both tools compared here performed psychometrically equally well. Their clinical utility, however, can be improved, for example by providing a manual (CHIPPS) and training opportunities. [ABSTRACT FROM AUTHOR]

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Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Mediation analysis allows the examination of effects of a third variable in the pathway between an exposure and an outcome. The general multiple mediation analysis method, proposed by Yu et al, improves traditional methods (eg, estimation of natural and controlled direct effects) to enable consideration of multiple mediators/confounders simultaneously and the use of linear and nonlinear predictive models for estimating mediation/confounding effects. In this paper, we extend the method for time-to-event outcomes and apply the method to explore the racial disparity in breast cancer survivals. Breast cancer is the most common cancer and the second leading cause of cancer death among women of all races. Despite improvement of survival rates of breast cancer in the US, a significant difference between white and black women remains. Previous studies have found that more advanced and aggressive tumors and less than optimal treatment may explain the lower survival rates for black women as compared to white women. Due to limitations of current analytic methods and the lack of comprehensive data sets, researchers have not been able to differentiate the relative effect each factor contributes to the overall racial disparity. We use the CDC-funded Patterns of Care study to examine the determinants of racial disparities in breast cancer survival using a novel multiple mediation analysis. Using the proposed method, we applied the Cox hazard model and multiple additive regression trees as predictive models and found that all racial disparity in survival among Louisiana breast cancer patients were explained by factors included in the study. [ABSTRACT FROM AUTHOR]

In this paper, we propose a large-scale multiple testing procedure to find the significant sub-areas between two samples of curves automatically. The procedure is optimal in that it controls the directional false discovery rate at any specified level on a continuum asymptotically. By introducing a nonparametric Gaussian process regression model for the two-sided multiple test, the procedure is computationally inexpensive. It can cope with problems with multidimensional covariates and accommodate different sampling designs across the samples. We further propose the significant curve/surface, giving an insight on dynamic significant differences between two curves. Simulation studies demonstrate that the proposed procedure enjoys superior performance with strong power and good directional error control. The procedure is also illustrated with the application to two executive function studies in hemiplegia. [ABSTRACT FROM AUTHOR]

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Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)