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Reviews methods for analyzing outcome data when some data are missing. Presents approach for comparing outcome results in two-group, randomized design with missing data. Proposed analysis is based on concept of "modeling our ignorance" by examining all possible outcomes, given known number of missing results with binary outcome, and then describing distribution of those results. (Author/NB)

Introduction: Addiction treatment clients are more likely to die of tobacco-related diseases than of alcohol or illicit drug-related causes. We aimed to assess smoking behavior, and smoking-related attitudes and services, in New York addiction treatment programs before a statewide smoking ban in treatment facilities was implemented (2008), 1 year (2009) and 5 years after implementation (2013).Methods: We conducted surveys at each time point with clients (N = 329, 341, and 353, respectively) and staff (N = 202, 203, and 166, respectively) from five residential and two methadone maintenance programs in New York State. At each data collection wave, questionnaires measured smoking behavior as well as smoking-related knowledge, attitudes, and experiences with tobacco cessation services as part of addiction treatment.Results: Staff smoking prevalence decreased from 35.2% in 2008 to 21.8% in 2013 (P = .005) while client smoking prevalence over the same period was unchanged (68.1% vs. 66.0%, P = .564). Among clients who smoked, mean cigarettes per day decreased from 13.7 (SD = 8.38) to 10.2 (SD = 4.44; P < .001). There were significant time-by-treatment-type interactions for client tobacco-related attitudes and cessation services received; and for staff self-efficacy and cessation services provided. In residential programs, scores for most items decreased (became less positive) in 2009 followed by a partial rebound in 2013. Methadone program scores tended to rise (become more positive) throughout the study period.Conclusions: Staff and clients may respond differentially to tobacco-free policies depending on type of treatment program, and this finding may help to inform the implementation of tobacco-free policies in other statewide addiction treatment systems. [ABSTRACT FROM AUTHOR]

Objectives: The cognitive characteristics of individuals with hoarding disorder (HD) are not well understood. Existing studies are relatively few and somewhat inconsistent but suggest that individuals with HD may have specific dysfunction in the cognitive domains of categorization, speed of information processing, and decision making. However, there have been no studies evaluating the degree to which cognitive dysfunction in these domains reflects clinically significant cognitive impairment (CI).Methods: Participants included 78 individuals who met DSM-V criteria for HD and 70 age- and education-matched controls. Cognitive performance on measures of memory, attention, information processing speed, abstract reasoning, visuospatial processing, decision making, and categorization ability was evaluated for each participant. Rates of clinical impairment for each measure were compared, as were age- and education-corrected raw scores for each cognitive test.Results: HD participants showed greater incidence of CI on measures of visual memory, visual detection, and visual categorization relative to controls. Raw-score comparisons between groups showed similar results with HD participants showing lower raw-score performance on each of these measures. In addition, in raw-score comparisons HD participants also demonstrated relative strengths compared to control participants on measures of verbal and visual abstract reasoning.Conclusions: These results suggest that HD is associated with a pattern of clinically significant CI in some visually mediated neurocognitive processes including visual memory, visual detection, and visual categorization. Additionally, these results suggest HD individuals may also exhibit relative strengths, perhaps compensatory, in abstract reasoning in both verbal and visual domains. [ABSTRACT FROM AUTHOR]

Background: Mental disorders are the leading global cause of years lived with disability; the majority of this burden exists in low and middle income countries (LMICs). Over half of mental illness is attributable to depression and anxiety disorders, both of which have known treatments. While the scarcity of mental health care providers is recognized as a major contributor to the magnitude of untreated disorders in LMICs, studies in LMICs find that evidence-based treatments for depression and anxiety disorders, such as brief, structured psychotherapies, are feasible, acceptable and have strong efficacy when delivered by local non-specialist personnel. However, most mental health treatment studies using non-specialist providers in LMICs deploy traditional efficacy designs (T1) without the benefit of integrated mental health treatment models shown to succeed over vertical interventions or methods derived from new implementation science to speed policy change. Here, we describe an effectiveness-implementation hybrid study that evaluates non-specialist delivery of mental health treatment within an HIV clinic for HIV-positive (HIV+) women affected by gender- based violence (GBV) (HIV+ GBV+) in the Nyanza region of Kenya.Methods/design: In this effectiveness-implementation hybrid type I design, 200 HIV+ women with major depressive disorder (MDD) and posttraumatic stress disorder (PTSD) who are receiving care at a Family AIDS Care Education and Services (FACES)-supported clinic in Kisumu, Kenya will be randomized to: (1) interpersonal psychotherapy (IPT) + treatment as usual (TAU) or (2) TAU, both delivered within the HIV clinic. IPT will consist of 12 weekly 60-minute individual IPT sessions, delivered by non-specialists trained to provide IPT. Primary effectiveness outcomes will include MDD and PTSD diagnosis on the Mini International Diagnostic Interview (MINI). Primary implementation outcomes will include treatment cost-benefit, acceptability, appropriateness, feasibility and fidelity of the IPT delivery within an HIV clinic.Discussion: This trial leverages newly defined effectiveness-implementation hybrid designs to gather data on mental health treatment implementation within an HIV care clinic, while testing the effectiveness of an evidence-based treatment for use with a large underserved population (HIV+ GBV+ women) in Kenya.Trial Registration: Clinical Trials Identifier: NCT02320799, registered on 9 September 2014. [ABSTRACT FROM AUTHOR]

Background: Due to the clinical challenges of treatment-resistant depression (TRD), we evaluated the efficacy of mindfulness-based cognitive therapy (MBCT) relative to a structurally equivalent active comparison condition as adjuncts to treatment-as-usual (TAU) pharmacotherapy in TRD.Methods: This single-site, randomized controlled trial compared 8-week courses of MBCT and the Health Enhancement Program (HEP), comprising physical fitness, music therapy and nutritional education, as adjuncts to TAU pharmacotherapy for outpatient adults with TRD. The primary outcome was change in depression severity, measured by percent reduction in the total score on the 17-item Hamilton Depression Rating Scale (HAM-D17), with secondary depression indicators of treatment response and remission.Results: We enrolled 173 adults; mean length of a current depressive episode was 6.8 years (SD = 8.9). At the end of 8 weeks of treatment, a multivariate analysis showed that relative to the HEP condition, the MBCT condition was associated with a significantly greater mean percent reduction in the HAM-D17 (36.6 vs. 25.3%; p = 0.01) and a significantly higher rate of treatment responders (30.3 vs. 15.3%; p = 0.03). Although numerically superior for MBCT than for HEP, the rates of remission did not significantly differ between treatments (22.4 vs. 13.9%; p = 0.15). In these models, state anxiety, perceived stress and the presence of personality disorder had adverse effects on outcomes.Conclusions: MBCT significantly decreased depression severity and improved treatment response rates at 8 weeks but not remission rates. MBCT appears to be a viable adjunct in the management of TRD. [ABSTRACT FROM AUTHOR]

Background: Tobacco use remains the leading cause of premature morbidity and mortality in the United States. Young adults are less successful at quitting, use cessation treatment less often than smokers of other ages, and can be a challenge to retain in treatment. Social media, integrated into the lives of many young adults, represents a promising strategy to deliver evidence-based smoking cessation treatment to a large, diverse audience. The goal of this trial is to test the efficacy of a stage-based smoking cessation intervention on Facebook for young adults age 18 to 25 on smoking abstinence, reduction in cigarettes smoked, and thoughts about smoking abstinence.Methods/design: This is a randomized controlled trial. Young adult smokers throughout the United States are recruited online and randomized to either the 3 month Tobacco Status Project intervention on Facebook or a referral to a smoking cessation website. The intervention consists of assignment to a secret Facebook group tailored to readiness to quit smoking (precontemplation, contemplation, preparation), daily Facebook contacts tailored to readiness to quit smoking, weekly live counseling sessions, and for those in preparation, weekly Cognitive Behavioral Therapy counseling sessions on Facebook. Primary outcome measure is biochemically-verified 7-day point prevalence abstinence from smoking at posttreatment (3 months), 6, and 12 months. Secondary outcome measures are reduction of 50 % or more in cigarettes smoked, 24 h quit attempts, and commitment to abstinence at each time point. A secondary aim is to test, within the TSP condition, the effect of a monetary incentive at increasing engagement in the intervention.Discussion: This randomized controlled trial is testing a novel Facebook intervention for treating young adults' tobacco use. If efficacious, the social media intervention could be disseminated widely and expanded to address additional health risks.Trial Registration: ClinicalTrials.gov: NCT02207036 , May 13, 2014. [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have "treatment-resistant depression" (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial. Methods/Design: The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1-7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology (QIDS-SR) 16-item scale was the secondary outcome measure of depression severity, response, and remission. Discussion: Treatment-resistant depression entails significant morbidity and has few effective treatments. We studied the effect of augmenting antidepressant medication with MBCT, compared with a HEP control, for patients with TRD. Analyses will focus on clinician and patient assessment of depression, participants' clinical global impression change, employment and social functioning scores and quality of life and satisfaction ratings. [ABSTRACT FROM AUTHOR]

Introduction: Alcohol and marijuana are among the most commonly used substances together with tobacco worldwide, but their relationship to smoking cessation is unclear. Although alcohol use decreases the likelihood of abstinence from tobacco, mechanisms of this effect have not been identified. Moreover, a small literature has yielded inconsistent findings regarding the effect of marijuana use on tobacco dependence treatment outcome. The aims of this study were to test increased positive-reinforcement smoking urge as a mediator of the relationship between alcohol and cigarette use and evaluate the impact of marijuana use on abstinence from tobacco.Methods: Participants were adult cigarette smokers (N = 739) from 3 randomized clinical trials of smoking cessation treatment. Alcohol consumption and marijuana use were assessed at pretreatment and postcessation. Biochemically verified, 7-day point prevalence smoking abstinence was determined at Weeks 12, 24, 36, and 52, as were urges to smoke as measured by the Questionnaire of Smoking Urges.Results: Increased positive-reinforcement urge mediated the effect of postcessation alcohol use on smoking abstinence. Although pretreatment alcohol use was associated with a decreased likelihood of abstinence from tobacco, increased positive-reinforcement urge did not account for this relationship. Marijuana use was not associated with abstinence from tobacco.Conclusions: Smoking cessation treatments should provide those who drink during a quit attempt techniques designed to mitigate positive-reinforcement urge to smoke. Additional research is needed to determine how pretreatment alcohol consumption exerts its effect on cigarette use. Modifying the use of marijuana might not be critical to the success of tobacco interventions. [ABSTRACT FROM AUTHOR]

To develop and validate a measure of smokers' expectancies for the abstinence process upon quitting smoking: the Smoking Abstinence Questionnaire (SAQ). Principal component analysis and other psychometric analyses of self-report data. San Francisco, California. A total of 507 adult smokers of at least 10 cigarettes per day diverse in gender, sexual orientation and ethnoracial status. The primary measure was a draft version of the SAQ. Additional measures assessed a variety of other smoking-related constructs. Analyses yielded 10 scales of the SAQ: Withdrawal, Social Improvement/Non-smoker Identity, Adverse Outcomes, Treatment Effectiveness, Common Reasons, Barriers to Treatment, Social Support, Optimistic Outcomes, Coffee Use and Weight Gain. The SAQ scales demonstrated internal consistencies ranging from 0.62 to 0.85 and were associated with tobacco dependence, motivation to quit, abstinence self-efficacy, withdrawal symptoms, dietary restraint, shape and weight concern and tobacco use expectancies. The SAQ predicted smoking-related constructs above and beyond tobacco use expectancies, suggesting that abstinence-related expectancies and tobacco use expectancies are distinct from one another. A newly developed questionnaire, the Smoking Abstinence Questionnaire, appears to capture reliably smokers' expectancies for abstinence (Withdrawal, Social Improvement/Non-smoker Identity, Adverse Outcomes, Common Reasons, Optimistic Outcomes, Coffee Use, and Weight Gain) and expectancies related to the success of a quit attempt (Treatment Effectiveness, Barriers to Treatment and Social Support). It remains to be seen how far any of these expectancies predict attempts to quit, withdrawal, treatment utilization and response and quitting success above and beyond existing measures. [ABSTRACT FROM AUTHOR]

Objective: The Patient Health Questionnaire depression scale (PHQ-9) is a well-validated, Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) criterion-based measure for diagnosing depression, assessing severity and monitoring treatment response. The performance of most depression scales including the PHQ-9, however, has not been rigorously evaluated in different racial/ethnic populations. Therefore, we compared the factor structure of the PHQ-9 between different racial/ethnic groups as well as the rates of endorsement and differential item functioning (DIF) of the 9 items of the PHQ-9. The presence of DIF would indicate that responses to an individual item differ significantly between groups, controlling for the level of depression.Measurements: A combined dataset from 2 separate studies of 5,053 primary care patients including non-Hispanic white (n=2,520), African American (n=598), Chinese American (n=941), and Latino (n=974) patients was used for our analysis. Exploratory principal components factor analysis was used to derive the factor structure of the PHQ-9 in each of the 4 racial/ethnic groups. A generalized Mantel-Haenszel statistic was used to test for DIF.Results: One main factor that included all PHQ-9 items was found in each racial/ethnic group with alpha coefficients ranging from 0.79 to 0.89. Although endorsement rates of individual items were generally similar among the 4 groups, evidence of DIF was found for some items.Conclusions: Our analyses indicate that in African American, Chinese American, Latino, and non-Hispanic white patient groups the PHQ-9 measures a common concept of depression and can be effective for the detection and monitoring of depression in these diverse populations. [ABSTRACT FROM AUTHOR]

I reviewed sample estimation methods for research designs involving nonindependent data and a dichotomous response variable to examine the importance of proper sample size estimation and the need to align methods of sample size estimation with planned methods of statistical analysis. Examples and references to published literature are provided in this article. When the method of sample size estimation is not in concert with the method of planned analysis, poor estimates may result. The effects of multiple measures over time also need to be considered. Proper sample size estimation is often overlooked. Alignment of the sample size estimation method with the planned analysis method, especially in studies involving nonindependent data, will produce appropriate estimates. (Am J Public Health. 2004;94:372-377) [ABSTRACT FROM AUTHOR]

Objective: To determine if the declining trend in U.S. youth cigarette smoking changed after e-cigarettes were introduced, and if youth e-cigarette users would have been likely to smoke cigarettes based on psychosocial and demographic predictors of smoking.Methods: An interrupted time series analysis was used for cross-sectional data from the 2004 to 2018 National Youth Tobacco Surveys (NYTS) to assess changes in cigarette and e-cigarette use over time. A multivariable logistic regression model used 2004-2009 NYTS data on psychosocial risk factors to predict individual-level cigarette smoking risk from 2011 to 2018. Model-predicted and actual cigarette smoking behavior were compared.Results: The decline in current cigarette smoking slowed in 2014 (-0.75 [95% CI: -0.81, -0.68] to -0.26 [95% CI: -0.40, -0.12] percentage points per year). The decline in ever cigarette smoking accelerated after 2012 (-1.45 [95% CI: -1.59, -1.31] to -1.71 [95% CI: -1.75, -1.66]). Ever and current combined cigarette and/or e-cigarette use declined during 2011-2013 and increased during 2013-2014 with no significant change during 2014-2018 for either variable. The psychosocial model estimated that 69.0% of current cigarette smokers and 9.3% of current e-cigarette users (who did not smoke cigarettes) would smoke cigarettes in 2018.Conclusions: The introduction of e-cigarettes was followed by a slowing decline in current cigarette smoking, a stall in combined cigarette and e-cigarette use, and an accelerated decline in ever cigarette smoking. Traditional psychosocial risk factors for cigarette smoking suggest that e-cigarette users do not fit the traditional risk profile of cigarette smokers. [ABSTRACT FROM AUTHOR]