Search

Angela Yen Moore,1,2 James Del Rosso,3,4 Jodi L Johnson,5 Ayman Grada6,7 1Arlington Research Center, Inc., Arlington, TX, USA; 2Baylor University Medical Center, Dallas, TX, USA; 3JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV, USA; 4Touro University Nevada, Henderson, NV, USA; 5Departments of Dermatology and Pathology, Feinberg School of Medicine, Northwestern University, Evanston, IL, USA; 6R&D and Medical Affairs, Almirall (US), Exton, PA, USA; 7Department of Dermatology, Boston University School of Medicine, Boston, MA, USACorrespondence: Angela Yen MooreArlington Research Center, Inc., 711 East Lamar, Suite 200, Arlington, TX 76011, USATel +1 817 795-7546 ext. 328Email acderm@acderm.comAbstract: Sarecycline is a tetracycline-derived oral antibiotic, specifically designed for acne, and is approved by the Food and Drug Administration (FDA) in 2018 for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris (AV) in patients 9 years of age and older. It has been decades since a novel systemic antibiotic was approved to treat AV, a disease that affects up to 90% of teenagers and young adults worldwide and lasts well into adulthood. Sarecycline holds promise to yield fewer side effects than other commonly used broad-spectrum tetracyclines, including minocycline and doxycycline. The narrower spectrum of antibacterial activity of sarecycline, which specifically targets C. acnes and some Gram-positive bacteria with little or no activity against Gram-negative bacteria, suggests not only the potential for reduced emergence of antibiotic-resistant bacterial strains but also less disruption of the human gut microflora. Here, we review the key preclinical and clinical evidence on sarecycline.Keywords: acne vulgaris, antibiotic, narrow spectrum, tetracycline, sarecycline

Rifapentine is a highly active antituberculosis antibiotic with treatment-shortening potential; however, exposure-response relations and the dose needed for maximal bactericidal activity have not been established. We used pharmacokinetic/pharmacodynamic data from 657 adults with pulmonary tuberculosis participating in treatment trials to compare rifapentine ( n = 405) with rifampin ( n = 252) as part of intensive-phase therapy. Population pharmacokinetic/pharmacodynamic analyses were performed with nonlinear mixed-effects modeling. Time to stable culture conversion of sputum to negative was determined in cultures obtained over 4 months of therapy. Rifapentine exposures were lower in participants who were coinfected with human immunodeficiency virus, black, male, or fasting when taking drug. Rifapentine exposure, large lung cavity size, and geographic region were independently associated with time to culture conversion in liquid media. Maximal treatment efficacy is likely achieved with rifapentine at 1,200 mg daily. Patients with large lung cavities appear less responsive to treatment, even at high rifapentine doses. [ABSTRACT FROM AUTHOR]

Background: Cancer and Leukemia Group B (CALGB) Study 19802, a phase 2 study, evaluated whether dose intensification of daunorubicin and cytarabine could improve disease-free survival (DFS) in adults with acute lymphoblastic leukemia (ALL) and whether high-dose systemic and intrathecal methotrexate could replace cranial radiotherapy for central nervous system (CNS) prophylaxis.Methods: One hundred sixty-one eligible, previously untreated patients ages 16 to 82 years (median age, 40 years) were enrolled, and 33 (20%) were aged ≥60 years.Results: One hundred twenty-eight patients (80%) achieved complete remission (CR). Dose intensification of daunorubicin and cytarabine was feasible. At a median follow-up of 10.4 years for surviving patients, the 5-year DFS rate was 25% (95% confidence interval, 18%-33%), and the overall survival (OS) rate was 30% (95% confidence interval, 23%-37%). Patients aged <60 years who received the 80 mg/m(2) dose of daunorubicin had a DFS of 33% (95% confidence interval, 22%-44%) and an OS of 39% (95% confidence interval, 29%-49%) at 5 years. Eighty-four patients (52%) relapsed, including 9 patients (6%) who had isolated CNS relapses. The omission of cranial irradiation did not result in higher than historic CNS relapse rates.Conclusions: Intensive systemic, oral, and intrathecal methotrexate dosing permitted the omission of CNS irradiation in adult patients with ALL. This intensive approach using higher doses of daunorubicin and cytarabine failed to result in an overall improvement in DFS or OS compared with historic CALGB studies. Future therapeutic strategies for adults with ALL should be tailored to specific age and molecular genetic subsets. [ABSTRACT FROM AUTHOR]

Background: The standard clinical approach for reducing cardiovascular disease risk due to dyslipidemia is to prescribe changes in diet and physical activity. The purpose of the current study was to determine if, across a range of dietary patterns, there were variable lipoprotein responses to an aerobic exercise training intervention.Methods: Subjects were participants in the STRRIDE I, a supervised exercise program in sedentary, overweight subjects randomized to 6 months of inactivity or 1 of 3 aerobic exercise programs. To characterize diet patterns observed during the study, we calculated a modified z-score that included intakes of total fat, saturated fat, trans fatty acids, cholesterol, omega-3 fatty acids, and fiber as compared with the 2006 American Heart Association diet recommendations. Linear models were used to evaluate relationships between diet patterns and exercise effects on lipoproteins/lipids.Results: Independent of diet, exercise had beneficial effects on low-density lipoprotein cholesterol particle number, low-density lipoprotein cholesterol size, high-density lipoprotein cholesterol, high-density lipoprotein cholesterol size, and triglycerides (P < .05 for all). However, having a diet pattern that closely adhered to American Heart Association recommendations was not related to changes in these or any other serum lipids or lipoproteins in any of the exercise groups.Conclusions: We found that even in sedentary individuals whose habitual diets vary in the extent of adherence to AHA dietary recommendations, a rigorous, supervised exercise intervention can achieve significant beneficial lipid effects. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Empirical and theoretical literature suggests that stereotypical gender roles shape men's and women's health help-seeking behavior, and plays an important role in the treatment seeking delays of cardiac patients. We were interested in exploring the ways in which gender informs the experiences and help-seeking behavior of men and women who experienced the symptoms associated with acute cardiac events. We undertook 20 in-depth interviews between October 2007 and July 2008 with 11 men and 9 women recently diagnosed with an acute coronary syndrome in British Columbia, Canada. Participants were encouraged to tell their 'story' of the event that led to hospitalization and diagnosis, with a focus on the symptoms and decision making processes that occurred before and during the activation of health services: seeking the advice of others including colleagues, family members and healthcare professionals; calling 911; and attending an emergency department. Although we anticipated that distinctive patterns of help-seeking behavior aligned with stereotypical masculine and feminine ideals might emerge from our data, this was not always the case. We found some evidence of the influence of gender role ideology on the help-seeking behavior of both male and female participants. However, men's and women's experiences of seeking health care were not easily parsed into distinct binary gender patterns. Behavior that might stereotypically be considered to be 'masculine' or 'feminine' gender practice was shared by both male and female participants. Our findings undermine simple binary distinctions about gendered help-seeking prevalent in the literature, and contribute towards setting the direction of the future health policy and research agenda addressing the issue of gender and health help-seeking behavior. [ABSTRACT FROM AUTHOR]

Background: There is increasing public health evidence that women who use crack cocaine and are street-involved experience significant health problems and are more isolated with regards to accessing harm reduction and other health-related services. Simultaneously, there is growing acknowledgement that structural and 'everyday' violence are significant factors influencing the health of women who use illegal drugs. Little research has examined how these social processes play out for women who use crack cocaine. Methods: A critical ethnography informed by the theoretical constructs of structural and everyday violence and intersectionality was undertaken to explore women's use of crack cocaine within an inner-city neighbourhood in Western Canada. Data collection included baseline survey (n=126), participant observation and field notes, informal interviews (n=53), and in-depth interviews (n=13). Results: Based on thematic and theoretical analysis two interrelated themes were identified that reflected the interrelationships between women's use of crack, poverty, discrimination, racism, gendered relations of power, and legal policies and practices: (a) the context of health care; and (b) the smoking context. Conclusions: Structural inequities and 'everyday' violence are perilously damaging for women who use crack. Interventions to reduce these inequities are urgently needed if we are to reduce the significant suffering of women who are street-involved and use crack cocaine. [ABSTRACT FROM AUTHOR]

Objective: To examine the long-term safety and efficacy of three antipsychotics in early-onset schizophrenia spectrum disorders.Method: Patients (8 to 19 years old) who had improved during an 8-week, randomized, double-blind acute trial of olanzapine, risperidone, or molindone (plus benztropine) were eligible to continue on the same medication for up to 44 additional weeks under double-blind conditions. Adjunctive medications were allowed according to defined algorithms. Standardized symptom, safety, and functional assessments were conducted every 4 weeks.Results: Of the 116 youths randomized in the acute trial, 54 entered maintenance treatment (molindone, n = 20; olanzapine, n = 13; risperidone, n = 21). Fourteen (26%) completed 44 weeks of treatment. Adverse effects (n = 15), inadequate efficacy (n = 14), or study nonadherence (n = 8) were the most common reasons for discontinuation. The three treatment arms did not significantly differ in symptom decrease or time to discontinuation. Akathisia was more common with molindone and elevated prolactin concentrations more common with risperidone. Although weight gain and metabolic adverse events had occurred more often with olanzapine and risperidone during the acute trial, no significant between-drug differences emerged in most of these parameters during maintenance treatment.Conclusions: Only 12% of youths with early-onset schizophrenia spectrum disorders continued on their originally randomized treatment at 52 weeks. No agent demonstrated superior efficacy, and all were associated with side effects, including weight gain. Improved treatments are needed for early-onset schizophrenia spectrum disorders. Clinical trial registry information-Treatment of Schizophrenia and Related Disorders in Children and Adolescents; URL: http://www.clinicaltrials.gov, unique identifier: NCT00053703. [ABSTRACT FROM AUTHOR]

Introduction: This paper presents an oral history from the mid-1980s to 2009 of the start and evolution of the Multinational Association of Supportive Care in Cancer (MASCC) as seen through the recollections of the founders and early leaders. The growth of the supportive cancer care movement and MASCC's contribution to oncology supportive care is described.Discussion: As science was making progress towards better cancer treatment, a group of professionals began to research ways to prevent or mitigate the symptoms and side effects that accompany the disease and its treatments. Joining forces, they created an international, multidisciplinary organization to address and promulgate evidence-based practices of cancer supportive care. Through annual international scientific symposia, a peer-reviewed journal, an accessible website, and study group projects such as guidelines and tools, MASCC is accomplishing its mission. [ABSTRACT FROM AUTHOR]

Although nurses are encouraged to address patients' tobacco use, the integration of tobacco reduction into practice has not been consistent. An organizational behavior perspective was used to conceptualize hypothesized relationships among reported influencing factors (individual characteristics, role attitudes, perceived barriers, and workplace climate). Survey data collected at two Western Canadian hospitals (N = 214 nurses; 58% response) were used to test the model. The final model explained nearly 60% of variation in the nurses' tobacco reduction practice. Role attitude, perceived resource availability, co-worker's activities, and ability were the strongest contributors. Nurses' smoking status indirectly influenced practice through shaping role attitudes and perceived ability. Diverse leverage points to enhance nurses' involvement in patients' tobacco use were identified. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This study aimed to describe mental healthcare providers' attitudes about tobacco use, their personal smoking status, their confidence in offering smoking cessation support to clients living with severe mental illness, and the extent to which they incorporated smoking cessation interventions into their practice. The study also aimed to determine whether the providers' attitudes, smoking status, and confidence were associated with offering smoking cessation support to clients. METHODS: Self-administered questionnaires were distributed within community-based mental health agencies to those who provide care and support to adults living with severe mental illness. Outcomes measured included respondents' smoking status, attitudes related to the provision of smoking cessation support, confidence in providing smoking cessation intervention, and smoking cessation practices. We conducted multivariate analyses using logistic regression analyses to examine the factors associated with the providers' tobacco-related practices. RESULTS: In total 282 of 871 care providers responded to the survey, 22% of whom were current smokers. The providers who held sympathetic attitudes about their role and their clients' role in smoking cessation, who were never or former smokers, who were healthcare professionals rather than paraprofessionals, who had relatively more confidence, and who had more experience working in the mental health field were more likely to engage their clients in tobacco-related interventions. CONCLUSIONS: In this study the healthcare providers working in community-based mental health have a smoking prevalence rate that exceeds that of the region's general population and did not provide optimal smoking cessation support to their clients. PRACTICE IMPLICATIONS: Interventions that bolster the confidence of providers to engage is smoking cessation activities and that support a shift in attitudes about the role of tobacco use in mental health are required. [ABSTRACT FROM AUTHOR]

Rationale: Cavitary disease and delayed culture conversion have been associated with relapse. Combining patient characteristics and measures of bacteriologic response might allow treatment shortening with current drugs in some patients.Objectives: To assess whether treatment could be shortened from 6 to 4 months in patients with noncavitary tuberculosis whose sputum cultures converted to negative after 2 months.Methods: This study was a randomized, open-label equivalence trial. HIV-uninfected adults with noncavitary tuberculosis were treated daily with isoniazid, rifampin, pyrazinamide, and ethambutol for 2 months, followed by 2 months of isoniazid and rifampin. After 4 months, patients with drug-susceptible TB whose sputum cultures on solid media were negative after 8 weeks of treatment were randomly assigned to continue treatment for 2 more months or to stop treatment. Patients were followed for relapse for 30 months after beginning treatment.Measurements and Main Results: Enrollment was stopped by the safety monitoring committee after 394 patients were enrolled due to apparent increased risk for relapse in the 4-month arm. A total of 370 patients were eligible for per protocol analysis. Thirteen patients in the 4-month arm relapsed, compared with three subjects in the 6-month arm (7.0 vs. 1.6%; risk difference, 0.054; 95% confidence interval with Hauck-Anderson correction, 0.01-0.10).Conclusion: Shortening treatment from 6 to 4 months in adults with noncavitary disease and culture conversion after 2 months using current drugs resulted in a greater relapse rate. The combination of noncavitary disease and 2-month culture conversion was insufficient to identify patients with decreased risk for relapse. [ABSTRACT FROM AUTHOR]

Background The demand for percutaneous coronary intervention (PCI) exerts constant pressure on health care systems to meet the growing needs of patients. The practice of same-day discharge PCI has emerged as a medically safe option to optimize resource utilization and improve access to care. Aim The purpose of this study was to describe elective same-day discharge PCI patients' self-care behaviour in the two to five days following their procedure, and the factors associated with cardiac self-efficacy (CSE) and self-care agency (SCA). Methods Using a cross-sectional correlational design, 98 consecutive patients were contacted by telephone, following PCI, and asked about their CSE, SCA, and adherence to discharge recommendations. Associations between selected variables were explored through multiple regression analysis. Results The findings revealed a high degree of adherence to discharge recommendations, although participants' appreciation of the long term management of their chronic disease was limited. Factors associated with lower levels of CSE and SCA included the burden of having additional chronic co-morbidities, living alone and lacking social support, and a positive screening for psychosocial distress. Conclusion Same-day discharge PCI presents a sustainable option for delivery of care for most patients. Some clients may require additional support to manage the transition between acute intervention and chronic disease management. [ABSTRACT FROM AUTHOR]

RATIONALE: Moxifloxacin has potent activity against Mycobacterium tuberculosis in vitro and in a mouse model of antituberculosis (TB) chemotherapy, but data regarding its activity in humans are limited. OBJECTIVES: Our objective was to compare the antimicrobial activity and safety of moxifloxacin versus isoniazid during the first 8 weeks of combination therapy for pulmonary TB. METHODS: Adults with sputum smear-positive pulmonary TB were randomly assigned to receive either moxifloxacin 400 mg plus isoniazid placebo, or isoniazid 300 mg plus moxifloxacin placebo, administered 5 days/week for 8 weeks, in addition to rifampin, pyrazinamide, and ethambutol. All doses were directly observed. Sputum was collected for culture every 2 weeks. The primary outcome was negative sputum culture at completion of 8 weeks of treatment. MEASUREMENTS AND MAIN RESULTS: Of 433 participants enrolled, 328 were eligible for the primary efficacy analysis. Of these, 35 (11%) were HIV positive, 248 (76%) had cavitation on baseline chest radiograph, and 213 (65%) were enrolled at African sites. Negative cultures at Week 8 were observed in 90/164 (54.9%) participants in the isoniazid arm, and 99/164 (60.4%) in the moxifloxacin arm (P = 0.37). In multivariate analysis, cavitation and enrollment at an African site were associated with lower likelihood of Week-8 culture negativity. The proportion of participants who discontinued assigned treatment was 31/214 (14.5%) for the moxifloxacin group versus 22/205 (10.7%) for the isoniazid group (RR, 1.35; 95% CI, 0.81, 2.25). CONCLUSIONS: Substitution of moxifloxacin for isoniazid resulted in a small but statistically nonsignificant increase in Week-8 culture negativity. [ABSTRACT FROM AUTHOR]

In this paper we report on findings from a qualitative study of marijuana use by adolescents in two communities in British Columbia, Canada. During 2005 and 2006, 45 interviews were carried out at schools with students aged 13-18, with an aim of understanding how adolescents perceive their experiences with marijuana to be shaped by gender. While it has been established that patterns of use differ for girls and boys, there is relatively little qualitative research addressing marijuana smoking as gendered social practice. Drawing from contemporary social theories of gender our analysis explores the normative functions of gender discourse within adolescents' narratives, situating their descriptions of marijuana use within the context of the research interview and within the social contexts of drug use. The results highlight the challenges we encountered in asking about gender during one-to-one interviews, juxtaposed with examples from the narratives that illustrate how boys and girls use marijuana as a way of 'doing' gender. To conclude, we suggest how our findings can inform the design of gender-specific health messaging on adolescent marijuana use. [ABSTRACT FROM AUTHOR]

The purpose of this study was to examine the influence of mode of administration (internet-based, web survey format versus pencil-and-paper format) on responses to the Dimensions of Tobacco Dependence Scale (DTDS). Responses from 1,484 adolescents that reported using tobacco (mean age 16 years) were examined; 354 (23.9%) participants completed a web-based version and 1,130 (76.1%) completed a paper-based version of the survey. Both surveys were completed in supervised classroom environments. Use of the web-based format was associated with significantly shorter completion times and a small but statistically significant increase in the number of missing responses. Tests of measurement invariance indicated that using a web-based mode of administration did not influence the psychometric functioning of the DTDS. There were no significant differences between the web- and paper-based groups' ratings of the survey's length, their question comprehension, and their response accuracy. Overall, the results of the study support the equivalence of scores obtained from web- and paper-based versions of the DTDS in secondary school settings. [ABSTRACT FROM AUTHOR]

This article reports on a program evaluation of the Betty Ford Center Children's Program, a program specifically designed for the children of substance abusers. Approximately 160 participating children (aged 7-12) were evaluated at pretest and posttest using a comprehensive psychological battery; a subsample of 50 children participated in a follow-up telephone interview 6 months later. Results showed that children of substance abusers benefit from brief, intensive program efforts that serve their special circumstances and highlight the important role social workers and other clinicians have in helping children reevaluate how they are impacted by their parent's addiction. [ABSTRACT FROM AUTHOR]

Rationale: Linezolid, the first oxazolidinone approved for clinical use, has effective in vitro and promising in vivo activity against Mycobacterium tuberculosis.Objectives: To evaluate the early and extended early bactericidal activity of linezolid in patients with pulmonary tuberculosis.Methods: Randomized open label trial. Thirty patients with newly diagnosed smear-positive pulmonary tuberculosis (10 per arm) were assigned to receive isoniazid (300 mg daily) and linezolid (600 mg twice daily or 600 mg once daily) for 7 days. Sputum for quantitative culture was collected for 2 days before and then daily during 7 days of study drug administration. Bactericidal activity was estimated by measuring the decline in bacilli during the first 2 days (early bactericidal activity) and the last 5 days of study drug administration (extended early bactericidal activity).Measurements and Main Results: The mean early bactericidal activity of isoniazid (0.67 log10 cfu/ml/d) was greater than that of linezolid twice and once daily (0.26 and 0.18 log10 cfu/ml/d, respectively). The extended early bactericidal activity of linezolid between Days 2 and 7 was minimal.Conclusions: Linezolid has modest early bactericidal activity against rapidly dividing tubercle bacilli in patients with cavitary pulmonary tuberculosis during the first 2 days of administration, but little extended early bactericidal activity. Clinical trial registered with www.clinicaltrials.gov (NCT00396084). [ABSTRACT FROM AUTHOR]

Cardiac disease is the number one killer of Canadian women. Therapy is highly time-dependent, yet treatment-seeking delay persists. The purpose of this grounded theory study was to explore how women seeking treatment for the symptoms of potential cardiac illness interpreted their symptoms, made decisions about seeking treatment, and understood experiences of care in the emergency department. Data were drawn from 100 hours of naturalistic observation, in-depth interviews with 16 women who visited one of two urban emergency departments between June 2005 and June 2006, and three interviews with nurses. The basic social psychological process of maintaining integrity was identified, encompassing three distinct phases: 'resisting disruption,' 'suspending agency,' and 'integrating experiences and knowledge.' The findings suggest that in the face of a threat to life, women are first and foremost striving to maintain both the integrity of their sense of self and their ability to carry out role responsibilities. [ABSTRACT FROM AUTHOR]

We examined whether differences in smoking rates of Asian and white/Caucasian youth could be explained by personal (gender, employment status, volunteerism, parental education, and income) and social factors including differences in youths' relationships with their parents, extent of enculturation, and exposure to parental or peer smoking. A survey was conducted of a random sample of schools in 2 cities in British Columbia, Canada to obtain data from 3,278 high school students. Results from logistic regression analysis indicated smoking status was explained by place of birth, volunteerism, amount of income received from parents and employers, characteristics of the parentalchild relationship, and parental and peer smoking status. Differences in the estimated risks of smoking of Asian youth and white youth were moderated by the youths' willingness to tell their parents about their lives, whether they worked for pay, and whether the Asian youth spoke English at home. [ABSTRACT FROM AUTHOR]

Nursing portfolios are purposeful collections of a nurse's tangible and intangible skills, including critical thinking, communication, and clinical abilities. They can be used for any number of creative career and professional development paths. Nurses should select portfolio pieces representative of their personal philosophy of nursing and display the professional image they choose to create. Through self-reflection, neonatal nurses may showcase talents they feel make their practice distinctive. This article describes the purpose, importance, process, and uses of professional nursing portfolio development. Through the process of self-reflective practice and clinical experience, nurses are empowered to continue on the path of career development and professionalism. [ABSTRACT FROM AUTHOR]

A survey of 3820 school children in England aged 13-16 years examined sexual activity using the Transtheoretical Model (TTM) Stages of Change. A quarter (26%) of teens were sexually experienced, 44.8 per cent did not use contraception and 48.9 per cent did not use condoms, every time. Past history of condom and contraceptive use, and partner willingness to use condoms were the best predictors of being in Action or Maintenance stage for condom use. Of virgins, 19.82 per cent were in Contemplation or Preparation stages for intercourse, and 85.4 per cent would use condoms every time. Sex education should be tailored to Stage, and signposting to sexual health and contraception services. Copyright © 2007 SAGE Publications Ltd. [ABSTRACT FROM AUTHOR]

If health psychology is to maximize impacts on health, there will need to be a shift from relying primarily on efficacy trials to increasing reliance on effectiveness trials. Efficacy trials use homogeneous, highly motivated samples with minimal complications from a single setting receiving intensive treatments delivered under highly controlled conditions. Two effectiveness trials on bullying prevention illustrate the use of a heterogeneous population from multiple sites receiving a low intensity tailored treatment delivered under highly variable conditions. In spite of considerable noise the effectiveness trials produced robust results (odds ratios of about four) that bode well for population impacts under real-world dissemination. Copyright © 2007 SAGE Publications Ltd. [ABSTRACT FROM AUTHOR]

Rationale: Moxifloxacin has promising preclinical activity against Mycobacterium tuberculosis, but has not been evaluated in multidrug treatment of tuberculosis in humans. Objective: To compare the impact of moxifloxacin versus ethambutol, both in combination with isoniazid, rifampin, and pyrazinamide, on sputum culture conversion at 2 mo as a measure of the potential sterilizing activity of alternate induction regimens. Methods: Adults with smear-positive pulmonary tuberculosis were randomized in a factorial design to receive moxifloxacin (400 mg) versus ethambutol given 5 d/wk versus 3 d/wk (after 2 wk of daily therapy). All doses were directly observed. Measurements: The primary endpoint was sputum culture status at 2 mo of treatment. Results: Of 336 patients enrolled, 277 (82%) were eligible for the efficacy analysis, 186 (67%) were male, 175 (63%) were enrolled at African sites, 206 (74%) had cavitation on chest radiograph, and 60 (22%) had HIV infection. Two-month cultures were negative in 71% of patients (99 of 139) treated with moxifloxacin versus 71% (98 of 138) treated with ethambutol (p = 0.97). Patients receiving moxifloxacin, however, more often had negative cultures after 4 wk of treatment. Patients treated with moxifloxacin more often reported nausea (22 vs. 9%, p = 0.002), but similar proportions completed study treatment (88 vs. 89%). Dosing frequency had little effect on 2-mo culture status or tolerability of therapy. Conclusions: The addition of moxifloxacin to isoniazid, rifampin, and pyrazinamide did not affect 2-mo sputum culture status but did show increased activity at earlier time points. [ABSTRACT FROM AUTHOR]

Stress has been associated with a variety of chronic and acute conditions and with higher use of health care services. This research reports on 18-month outcomes of a randomized clinical trial of a stress-management program based on the transtheoretical model (TTM; J. O. Prochaska & C. C. DiClemente, 1986). A national sample of 1,085 individuals participated (age range = 18-91 years, M = 55.33; 68.9% female, 31.1% male; 84.8% Caucasian; 15.2% non-Caucasian). Both the treatment and control groups received assessments at 0, 6, 12, and 18 months. In addition to the assessments, the treatment group received 3 individualized reports (0, 3, 6 months) and a manual. The 18-month assessment was completed by 778 individuals (72%). A random effects model indicated that participants completing the study in the treatment group had significantly more individuals reporting effective stress management at follow-up time points than did completers in the control group. Results also indicate that the intervention had significant effects on stress, depression, and specific stress-management behaviors. Results provide evidence for the effectiveness of this TTM population-based stress-management intervention. Copyright © 2006 by the American Psychological Association, Inc. [ABSTRACT FROM AUTHOR]