Use of a liquid nicotine delivery product to promote smoking cessation

<p>Abstract</p> <p>Background</p> <p>Despite access to various pharmacotherapies and counseling support to aid cessation, smokers typically demonstrate quit rates below 50%. This report describes the results of a Phase 2a study exploring the efficacy of a liquid nicotine delivery system as an aid to smoking cessation assessed after 12 weeks of therapy.</p> <p>Methods</p> <p>A single-arm Phase 2a study was conducted. Community-based smokers (ages 18+ years, smoking at least 10 cigarettes daily for the past year and interested in making a quit attempt) were recruited and completed clinic visits at 2 week intervals over the 12 week study period where carbon monoxide levels were assessed and the Smoke-Break product was rated on taste and overall satisfaction. Participants were provided with a supply of liquid nicotine cigarettes (e.g., Smoke-Break) at each clinic visit. A total of 69 smokers were enrolled and received the intervention product (intention to treat group, ITT) and 52 smokers verified participation (according to protocol group, ATP).</p> <p>Results</p> <p>The cessation rate at 12 weeks after the baseline visit, assessed as the bioverified point prevalence of abstinence, was 71.1% (95% confidence interval [CI] 58.8%-83.5%) in the ATP group and 53.6% (41.8%-65.4%) in the ITT group. Participants rated the liquid nicotine delivery system highly and also expressed general satisfaction. Few adverse events were identified with no serious adverse events.</p> <p>Conclusions</p> <p>These results support the efficacy of the liquid nicotine delivery system in smoking cessation. If this nicotine delivery product proves to be effective in larger trials, it could represent an inexpensive, readily accessible and well-tolerated agent to promote smoking cessation.</p> <p>Trial Registration</p> <p>This trial is registered at clinicaltrials.gov as study NCT00715871.</p

Developing a Series of AI Challenges for the United States Department of the Air Force

Through a series of federal initiatives and orders, the U.S. Government has been making a concerted effort to ensure American leadership in AI. These broad strategy documents have influenced organizations such as the United States Department of the Air Force (DAF). The DAF-MIT AI Accelerator is an initiative between the DAF and MIT to bridge the gap between AI researchers and DAF mission requirements. Several projects supported by the DAF-MIT AI Accelerator are developing public challenge problems that address numerous Federal AI research priorities. These challenges target priorities by making large, AI-ready datasets publicly available, incentivizing open-source solutions, and creating a demand signal for dual use technologies that can stimulate further research. In this article, we describe these public challenges being developed and how their application contributes to scientific advances

Patterns of Growth and Decline in Lung Function in Persistent Childhood Asthma

BACKGROUND: Tracking longitudinal measurements of growth and decline in lung function in patients with persistent childhood asthma may reveal links between asthma and subsequent chronic airflow obstruction. METHODS: We classified children with asthma according to four characteristic patterns of lung-function growth and decline on the basis of graphs showing forced expiratory volume in 1 second (FEV1), representing spirometric measurements performed from childhood into adulthood. Risk factors associated with abnormal patterns were also examined. To define normal values, we used FEV1 values from participants in the National Health and Nutrition Examination Survey who did not have asthma. RESULTS: Of the 684 study participants, 170 (25%) had a normal pattern of lung-function growth without early decline, and 514 (75%) had abnormal patterns: 176 (26%) had reduced growth and an early decline, 160 (23%) had reduced growth only, and 178 (26%) had normal growth and an early decline. Lower baseline values for FEV1, smaller bronchodilator response, airway hyperresponsiveness at baseline, and male sex were associated with reduced growth (P<0.001 for all comparisons). At the last spirometric measurement (mean [±SD] age, 26.0±1.8 years), 73 participants (11%) met Global Initiative for Chronic Obstructive Lung Disease spirometric criteria for lung-function impairment that was consistent with chronic obstructive pulmonary disease (COPD); these participants were more likely to have a reduced pattern of growth than a normal pattern (18% vs. 3%, P<0.001). CONCLUSIONS: Childhood impairment of lung function and male sex were the most significant predictors of abnormal longitudinal patterns of lung-function growth and decline. Children with persistent asthma and reduced growth of lung function are at increased risk for fixed airflow obstruction and possibly COPD in early adulthood. (Funded by the Parker B. Francis Foundation and others; ClinicalTrials.gov number, NCT00000575.

On the maximum total sample size of a group sequential test about bivariate binomial proportions

For testing "univariate" binomial proportions, it has been proven that, under mild conditions, there exist group sequential designs which satisfy the pre-specified Type I error and power of the single-stage design while the sample size is bounded above by that of the single-stage design (Kepner and Chang, 2003). In this article, we extend this result and prove the existence of such group sequential designs for various decision rules in the space of bivariate binomial variables. We also demonstrate how to obtain the actual group sequential designs for detecting changes in bivariate binomial variables.Bivariate binomial distribution Cancer clinical trials Cytostatic treatment Decision rule Toxicity evaluation

A Note on Evaluating a Certain Orthant Probability

Using only a first-year calculus background, a closed-form expression for an orthant probability is derived. The result and examples are appropriate for students in their first course in the theory of nonparametric statistics

On the maximum total sample size of a group sequential test about binomial proportions

It is well known that the standard single-stage binomial test is uniformly most powerful to detect an increase or decrease in a binomial proportion. The general perception is that, to achieve a fixed significance level and power, a group sequential test will require a larger maximum total sample size than required by the corresponding standard single-stage test because missing observations are possible under the group sequential test setting. In this article, it is proved that, under mild conditions, there exist group sequential tests which achieve the predesignated significance level and power with maximum total sample size bounded above by the sample size for the corresponding standard single-stage test.Uniformly most powerful test Minimax design Type 1-3 design Power function

Predeposit Autologous Blood Transfusion: An Analysis of Donor Attitudes and Attributes

Abstract Predeposit autologous blood transfusion now accounts for 11% of the total transfusion volume at Saint Cloud Hospital in Minnesota. This hospitalwide program represents a major positive quality assurance/risk management change in transfusion practice. To understand the factors responsible for the success of the program, a questionnaire was sent to 224 patients donating during a 26-month period ending July 1, 1985. Factors important in the increasing utilization of the program include donor acceptance, clinician referrals, and perceived lack of conflict with the homologous donation process

Exact power calculations for detecting hypotheses involving two correlated binary outcomes

Exact power calculations to jointly test two correlated binomial outcomes are discussed using Biswas and Hwang's bivariate binomial distribution. We prove that power is a non-decreasing function of correlation. The method is extended to two-stage exact group sequential designs.Exact test Group sequential test Bivariate binomial distribution Correlated binary variables