Increased blood coagulation is associated with poor neurological outcome in aneurysmal subarachnoid hemorrhage.

Background And Purpose: Patients with aneurysmal subarachnoid hemorrhage (aSAH) have demonstrated increased blood coagulation which is thought to contribute to delayed cerebral ischemia (DCI) and to a worse outcome. Therefore, we sought to determine whether this increased blood coagulation, detectable with rotational thromboelastometry (ROTEM), was associated with DCI and neurological outcome.

Methods: We conducted a prospective observational study of 60 consecutive adult aSAH patients.

Establishing the safety of phenobarbital treatment of alcohol withdrawal syndrome on general medical wards: A retrospective cohort study.

Introduction: Concern about adverse effects from phenobarbital limits its use in treating alcohol withdrawal syndrome (AWS) on general medical wards. Benzodiazepines are the recommended treatment for inpatient management of AWS, yet a subset of patients have an inadequate response or experience complications of AWS despite treatment with benzodiazepines. Data supporting an alternative treatment are needed.

Association Between Vertebral Dimensions and Lumbar Modic Changes.

Study Design: Population-based birth cohort study.

Objective: The aim of this study was to evaluate the relationship between vertebral dimensions and lumbar MC.

Summary Of Background Data: Low back pain (LBP) has become the leading cause of disability worldwide.

Association between device-measured physical activity and lumbar Modic changes.

Background: Modic changes (MC) in the lumbar spine are considered one potential etiological factor behind low back pain (LBP). Multiple risk factors for MC have been suggested, including male gender, smoking and factors affecting hyperloading and mechanical stress such as high body mass index (BMI), strenuous physical work and high occupational and leisure-time physical activity (PA). So far, the effect of PA on the occurrence of MC has remained under debate due to contradictory findings.

Community-acquired Pneumonia Guideline Recommendations-Impact of a Consensus-based Process versus Systematic Reviews.

Background: The American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) Community-acquired Pneumonia (CAP) guidelines were developed using systematic reviews to inform every recommendation, as suggested by the Institute of Medicine Standards for Trustworthy Guidelines. Recent studies suggest that an expert consensus-based approach, called the Convergence of Opinion on Recommendations and Evidence (CORE) process, can produce recommendations that are concordant with recommendations informed by systematic reviews.

Purpose: The goal of the study was to evaluate the efficacy of the CORE process had it been used to develop the ATS/IDSA CAP guidelines.

Association Between Modic Changes and Low Back Pain in Middle Age: A Northern Finland Birth Cohort Study.

Study Design: A cross-sectional study of the Northern Finland Birth Cohort 1966 (NFBC1966).

Objective: The aim of this study was to evaluate the association between the type, size, and location of lumbar Modic changes (MC), and prolonged disabling low back pain (LBP).

Summary Of Background Data: LBP is the leading cause of disability worldwide and it affects all age- and socioeconomical groups.

Nonparticipation reasons in a randomized international trial of a new latent tuberculosis infection regimen.

Background/aims: Efficient recruitment of eligible participants, optimizing time and sample size, is a crucial component in conducting a successful clinical trial. Inefficient participant recruitment can impede study progress, consume staff time and resources, and limit quality and generalizability or the power to assess outcomes. Recruitment for disease prevention trials poses additional challenges because patients are asymptomatic.

Factors associated with non-completion of follow-up: 33-month latent tuberculous infection treatment trial.

Setting: A post-hoc exploratory analysis of a randomized, open-label clinical trial that enrolled 8053 participants from the United States, Canada, Brazil, and Spain.

Objective: To assess factors associated with non-completion of study follow-up (NCF) in a 33-month latent tuberculous infection treatment trial, PREVENT TB.

Design: Participants were randomized to receive 3 months of weekly directly observed therapy vs.

Executive Summary: Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.

The American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America jointly sponsored the development of this guideline for the treatment of drug-susceptible tuberculosis, which is also endorsed by the European Respiratory Society and the US National Tuberculosis Controllers Association. Representatives from the American Academy of Pediatrics, the Canadian Thoracic Society, the International Union Against Tuberculosis and Lung Disease, and the World Health Organization also participated in the development of the guideline. This guideline provides recommendations on the clinical and public health management of tuberculosis in children and adults in settings in which mycobacterial cultures, molecular and phenotypic drug susceptibility tests, and radiographic studies, among other diagnostic tools, are available on a routine basis.

Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis.

The American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America jointly sponsored the development of this guideline for the treatment of drug-susceptible tuberculosis, which is also endorsed by the European Respiratory Society and the US National Tuberculosis Controllers Association. Representatives from the American Academy of Pediatrics, the Canadian Thoracic Society, the International Union Against Tuberculosis and Lung Disease, and the World Health Organization also participated in the development of the guideline. This guideline provides recommendations on the clinical and public health management of tuberculosis in children and adults in settings in which mycobacterial cultures, molecular and phenotypic drug susceptibility tests, and radiographic studies, among other diagnostic tools, are available on a routine basis.

Clinical Characteristics and the Dietary Response in Celiac Disease Patients Presenting With or Without Anemia.

Background And Aims: It remains unclear as to what are the clinical characteristics associated with the presence of anemia at celiac disease diagnosis, and how these are affected by a gluten-free diet. We investigated these issues in a prospective study.

Methods: Clinical and demographic data, small-bowel mucosal histology, serology, and laboratory parameters, body mass index (BMI), and bone mineral density (BMD) both at diagnosis and after 1 year on a gluten-free diet were investigated in 163 adults with celiac disease.

Factors Associated With Noncompletion of Latent Tuberculosis Infection Treatment: Experience From the PREVENT TB Trial in the United States and Canada.

Background: Overall rates of noncompletion of treatment (NCT) for latent tuberculosis infection (LTBI) in the PREVENT TB trial were 18% for 3 months of directly observed once-weekly rifapentine (maximum dose, 900 mg) plus isoniazid (maximum dose, 900 mg) (3HP-DOT) and 31% for 9 months of daily self-administered isoniazid (maximum dose, 300 mg; 9H-SAT). NCT for LTBI reduces its effectiveness. The study objective was to assess factors associated with NCT for LTBI among adult participants enrolled at US and Canadian sites of the PREVENT TB trial.

Serum biomarkers of treatment response within a randomized clinical trial for pulmonary tuberculosis.

Rationale: Biomarkers for monitoring response to anti-tuberculosis treatment are needed. We explored immune markers previously published as having predictive capability for 8 week culture status in 39 adults enrolled in a clinical trial in Kampala, Uganda.

Methods: We consecutively selected 20 HIV-negative pulmonary TB subjects with positive cultures, and 19 subjects with negative cultures at the end of intensive phase therapy.

Barriers to accepting and completing latent tuberculosis infection treatment.

Treatment of Latent Tuberculosis Infection (LTBI) is an important component of any TB control strategy. Acceptance and completion of treatment is poor. We undertook this study to identify barriers to acceptance & completion of treatment.

The association between symptoms and microbiologically defined response to tuberculosis treatment.

Rationale: The lack of consistent associations between clinical outcomes and microbiological responses to therapy for some infectious diseases has raised questions about the adequacy of microbiological endpoints for tuberculosis treatment trials.

Objectives: To evaluate the association between symptoms and microbiological response to tuberculosis treatment.

Methods: We performed a retrospective analysis of four clinical trials in which participants had culture-positive tuberculosis, standardized symptom assessment, and follow-up mycobacterial cultures.

Lessons from a randomised clinical trial for multidrug-resistant tuberculosis.

Background: The treatment of multidrug-resistant tuberculosis (MDR-TB) is currently based upon expert opinion and findings from case series, rather than upon randomised clinical trials (RCTs).

Objective: To describe the challenges encountered during an RCT for the treatment of MDR-TB.

Methods: Tuberculosis Trials Consortium Study 30 was a pilot, Phase I/II, double-blind, placebo-controlled, RCT of the safety and tolerability of 16 weeks of daily, low-dose linezolid treatment for MDR-TB.

Predictors of latent tuberculosis treatment initiation and completion at a U.S. public health clinic: a prospective cohort study.

Background: Treatment of latent tuberculosis infection (LTBI) is a key component in U.S. tuberculosis control, assisted by recent improvements in LTBI diagnostics and therapeutic regimens.

Reasons for non-participation in an international multicenter trial of a new drug for tuberculosis treatment.

Setting: Clinical trials can provide a high standard of patient care and contribute to scientific knowledge; however, only a fraction of the patients screened participate and receive treatment as part of a trial.

Objective: To explore reasons why patients were not enrolled in an international tuberculosis (TB) treatment trial and to compare experiences among study sites.

Design: An analysis of reasons why patients were not enrolled was conducted among patients screened for a TB clinical trial at 26 sites in North and South America, Africa, and Europe.

Acceptance of interferon-gamma release assay by a high-risk urban cohort.

Background: QuantiFERON ® -TB Gold (QFT-G), an interferon-gamma release assay, is approved for the diagnosis of latent tuberculosis infection (LTBI). It is unknown if patients at high risk for LTBI will more readily accept LTBI treatment based on tuberculosis skin testing (TST) or QFT-G.

Methods: Prospectively enrolled participants were interviewed, were read an informational paragraph on QFT-G, completed a questionnaire and were tested with QFT-G.

CDC/NIH Workshop. Tuberculosis biomarker and surrogate endpoint research roadmap.

The Centers for Disease Control and Prevention and National Institutes of Health convened a multidisciplinary meeting to discuss surrogate markers of treatment response in tuberculosis. The goals were to assess recent surrogate marker research and to provide specific recommendations for (1) the qualification and validation of biomarkers of treatment outcome; (2) the standardization of specimen and data collection for future clinical trials, including a minimum set of samples and collection time points; and (3) the creation ofa specimen repository to support biomarker testing. This article summarizes these recommendations and provides a roadmap for their implementation.

Design and Prototyping of a Low-Cost Portable Mechanical Ventilator.

This paper describes the design and prototyping of a low-cost portable mechanical ventilator for use in mass casualty cases and resource-poor environments. The ventilator delivers breaths by compressing a conventional bag-valve mask (BVM) with a pivoting cam arm, eliminating the need for a human operator for the BVM. An initial prototype was built out of acrylic, measuring and weighing 9 lbs.