Ehrlichiosis and anaplasmosis subcommittee report to the Tick-borne Disease Working Group.

Ehrlichioses and anaplasmosis have undergone dramatic increases in incidence, and the geographic ranges of their occurrence and vectors have also expanded. There is marked underreporting of these diseases owing to deficient physician awareness and knowledge of the illnesses as well as limited access to appropriate diagnostic tests. Human monocytic ehrlichiosis and anaplasmosis are life threatening diseases with estimated case fatality rates of 2.

Unsupervised Machine Learning for Identifying Challenging Behavior Profiles to Explore Cluster-Based Treatment Efficacy in Children With Autism Spectrum Disorder: Retrospective Data Analysis Study.

Background: Challenging behaviors are prevalent among individuals with autism spectrum disorder; however, research exploring the impact of challenging behaviors on treatment response is lacking.

Objective: The purpose of this study was to identify types of autism spectrum disorder based on engagement in different challenging behaviors and evaluate differences in treatment response between groups.

Methods: Retrospective data on challenging behaviors and treatment progress for 854 children with autism spectrum disorder were analyzed.

Evaluation of an Immersive Virtual Reality Safety Training Used to Teach Pedestrian Skills to Children With Autism Spectrum Disorder.

Children with autism spectrum disorder (ASD) are at an increased risk of injury, making safety skills training essential. Whether such training is conducted in the natural environment or in contrived settings is an important consideration for generalization and safety purposes. Immersive virtual reality (VR) environments may offer the advantages of both contrived and natural environment training settings, providing structure to create repeated learning opportunities in a safe and realistic analogue of the natural environment.

Identification and analysis of behavioral phenotypes in autism spectrum disorder via unsupervised machine learning.

Background And Objective: Autism spectrum disorder (ASD) is a heterogeneous disorder. Research has explored potential ASD subgroups with preliminary evidence supporting the existence of behaviorally and genetically distinct subgroups; however, research has yet to leverage machine learning to identify phenotypes on a scale large enough to robustly examine treatment response across such subgroups. The purpose of the present study was to apply Gaussian Mixture Models and Hierarchical Clustering to identify behavioral phenotypes of ASD and examine treatment response across the learned phenotypes.

An Evaluation of a Mobile Application Designed to Teach Receptive Language Skills to Children with Autism Spectrum Disorder.

The current study evaluated the effectiveness of a mobile application, Camp Discovery, designed to teach receptive language skills to children with autism spectrum disorder based on the principles of applied behavior analysis. Participants ( = 28) were randomly assigned to an immediate-treatment or a delayed-treatment control group. The treatment group made significant gains, < .

A Program Evaluation of Home and Center-Based Treatment for Autism Spectrum Disorder.

The present study aimed to retrospectively compare the relative rates of mastery of exemplars for individuals with ASD ( 313) who received home-based and center-based services. A between-group analysis found that participants mastered significantly more exemplars per hour when receiving center-based services than home-based services. Likewise, a paired-sample analysis found that participants who received both home and center-based services had mastered 100 % more per hour while at the center than at home.

An Evaluation of the Impact of Supervision Intensity, Supervisor Qualifications, and Caseload on Outcomes in the Treatment of Autism Spectrum Disorder.

Ample research has shown the benefits of intensive applied behavior analysis (ABA) treatment for autism spectrum disorder (ASD); research that investigates the role of treatment supervision, however, is limited. The present study examined the relationship between mastery of learning objectives and supervision hours, supervisor credentials, years of experience, and caseload in a large sample of children with ASD ( = 638). These data were retrieved from a large archival database of children with ASD receiving community-based ABA services.

Antimicrobial Resistance.

Importance: The development of antibiotics is considered among the most important advances of modern science. Antibiotics have saved millions of lives. However, antimicrobial resistance (AMR) threatens this progress and presents significant risks to human health.

Intensity and Learning Outcomes in the Treatment of Children With Autism Spectrum Disorder.

Ample research has shown that intensive applied behavior analysis (ABA) treatment produces robust outcomes for individuals with autism spectrum disorder (ASD); however, little is known about the relationship between treatment intensity and treatment outcomes. The current study was designed to evaluate this relationship. Participants included 726 children, ages 1.

Accelerating global innovation to address antibacterial resistance: introducing CARB-X.

A global response to the chronic shortfall in antibiotic innovation is urgently needed to combat antimicrobial resistance. Here, we introduce CARB-X, a new global public-private partnership that will invest more than US$350 million in the next 5 years to accelerate the progression of a diverse portfolio of innovative antibacterial products into clinical trials.

A Korean language translation of the Questions About Behavior Function: initial psychometric evaluation.

Identifying the function of behavior is crucial in formulating functionally-based treatment programs for people with challenging behaviors. The Questions About Behavior Function (QABF) is a well-established instrument with sound psychometric properties. The present study describes the development process for a Korean version of the QABF.

Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials.

Background: Historically, four divisions of the National Institute of Allergy and Infectious Diseases (NIAID) that manage clinical trials and oversee data and safety monitoring have operated fairly autonomously with respect to their approaches to Data and Safety Monitoring Board (DSMB) operations. We recognized the need for a revised policy on DSMB operations in an effort to encourage greater harmonization of procedures across the four divisions.

Purpose: The purpose of this article is to describe the considerations that motivated the development of the new policy, summarize current DSMB policies and ongoing harmonization efforts across the four divisions, and offer some recommendations for DSMB operations in the hope that other organizations may benefit from our experience.

Should sponsors and DSMBs share interim results across trials?

Increasing numbers of multinational clinical trials have generated new ethical obligations of research sponsors and their DSMBs. Although sponsors and DSMBs clearly have ethical obligations to protect subjects in their trials, future patients, and the integrity of their trial, the obligations they have to protect subjects in other trials have been overlooked. When interim results from clinical trials can significantly affect the conduct of other trials and the welfare of the subjects in those trials, sponsors and DSMBs may have obligations to disclose results to the relevant parties.

Strengthening biostatistics resources in sub-Saharan Africa: research collaborations through U.S. partnerships.

On September 30, 2009, the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) conducted a workshop on strengthening biostatistics resources in sub-Saharan Africa (SSA). An increase in global spending on health research over the last decade has boosted funds available to conduct biomedical research in low- to mid-income countries. The HIV/AIDS pandemic, the re-emergence of malaria and tuberculosis, and other emerging infectious agents are major driving forces behind the increase in biomedical research and clinical care programs (clinical trials, observational studies and, other public health programs) in SSA (Exp.

Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa.

Background: Most trials of interventions are designed to address the traditional null hypothesis of no benefit. VOICE, a phase 2B HIV prevention trial funded by NIH and conducted in Africa, is designed to assess if the intervention will prevent a substantial fraction of infections. Planned interim analysis may provide conclusive evidence against the traditional null hypothesis without establishing substantial benefit.

Pyrosequencing study of fecal microflora of autistic and control children.

There is evidence of genetic predisposition to autism, but the percent of autistic subjects with this background is unknown. It is clear that other factors, such as environmental influences, may play a role in this disease. In the present study, we have examined the fecal microbial flora of 33 subjects with various severities of autism with gastrointestinal symptoms, 7 siblings not showing autistic symptoms (sibling controls) and eight non-sibling control subjects, using the bacterial tag encoded FLX amplicon pyrosequencing (bTEFAP) procedure.

A review of research on procedures for teaching safety skills to persons with developmental disabilities.

Safety skills are an important but often neglected area of training for persons with developmental disabilities (DD). The present study reviewed the literature on teaching safety skills to persons with DD. Safety skills involve a variety of behaviors such as knowing how to cross the street or what to do in case of a house fire.

Retrospective analysis of clinical records in 38 cases of recovery from autism.

Background: Twenty years of research on early intensive treatment using applied behavior analysis (ABA) for children with autism has consistently produced robust effects. There appears to be a subset of children whose response to intensive ABA treatments includes achieving a level of functioning that is indistinguishable from typically developing peers. The purpose of this study was to describe a subset of children who recovered from autism following intensive ABA interventions.

Applied behavior analytic interventions for children with autism: a description and review of treatment research.

Background: Autism is a disorder characterized by pervasive delays in the development of language and socialization, and the presence of stereotyped, repetitive behaviors or nonfunctional interests. Although a multitude of treatments for autism exist, very few have been the subject of scientific research. The only treatment that has been supported by substantial empirical research is treatment based on applied behavior analysis (ABA).

Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases.

Background: A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research.