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We address several questions relating to the use of standard regression and Structural Nested Mean Model (SNMM) approach (e. g., Ten Have et al. 2007) to analyze post-randomization effect modifiers of the intent-to-treat effect of a randomized intervention on a subsequent outcome, which has not been well examined. We show through simulations that the SNMM performs better with respect to bias of estimates of the intervention and interaction effects than does the corresponding standard interaction approach when the baseline intervention is randomized and the post-randomization factors are subject to confounding, and even when there is no association between the intervention and effect modifier. However, causal inference under the SNMM makes untestable assumptions that the causal contrasts do not vary across observed levels of the intervention and post-randomization factor. In addition, the precision of the SNMM-based estimators depends on the effect of the randomized intervention on the post-randomization factor varying across baseline covariate combinations. These issues and methods are illustrated with the application of the standard and causal methods to a randomized cognitive therapy (CT) trial, for which there is a conceptual model of negative cognitive styles or distortions impacted by CT but then in turn modifying the effect of CT on subsequent suicide ideation and social problem solving outcomes.

Parkinson's disease (PD) significantly impacts both patients' and spouses' emotional and physical health. However, despite the importance of social relationships for wellbeing, few studies have examined relationship quality and their correlates in individuals with PD and their partners. Specifically, no known studies have examined the association between benefit finding, or the experience of personal growth and other positive changes in the face of a stressor, and perceived marital quality. To address these gaps in the field, 25 married couples participated in a cross-sectional, pilot study. Patients were veterans diagnosed with idiopathic PD receiving care at the Philadelphia VA Medical Center. Each patient and spouse independently completed self-reported measures of sociodemographics, physical and mental wellbeing, caregiver burden, marital quality, and perceived benefits associated with having PD. Actor-partner interdependence models revealed that, after adjusting for covariates, greater perceived benefits from either having PD or living with a spouse with PD was associated with greater marital quality, both for that individual and their partner. Thus, perceiving positive consequences, such as personal growth, as a result of personally having PD or living with a spouse with PD is related to greater marital quality for both members of the marital dyad. Findings may inform individual and couples-based interventions that address the value of benefit finding and incorporate other techniques of positive reappraisal.

Objectives: To evaluate an integrated telehealth intervention (Integrated Telehealth Education and Activation of Mood (I-TEAM)) to improve chronic illness (congestive heart failure, chronic obstructive pulmonary disease) and comorbid depression in the home healthcare setting. Design: Randomized controlled trial. Setting: Hospital-affiliated home healthcare setting. Participants: Medically frail older homebound individuals (N = 102). Intervention: The 3-month intervention consisted of integrated telehealth chronic illness and depression care, with a telehealth nurse conducting daily telemonitoring of symptoms, body weight, and medication use; providing eight weekly sessions of problem-solving treatment for depression; and providing for communication with participants' primary care physicians, who also prescribed antidepressants. Control participants were allocated to usual care with in-home nursing plus psychoeducation (UC+P). Measurements: The two groups were compared at baseline and 3 and 6 months after baseline on clinical measures (depression, health, problem-solving) and 12 months after baseline on health utilization (readmission, episodes of care, and emergency department (ED) visits). Results: Depression scores were 50% lower in the I-TEAM group than in the UC+P group at 3 and 6 months. Those who received the I-TEAM intervention significantly improved their problem-solving skills and self-efficacy in managing their medical condition. The I-TEAM group had significantly fewer ED visits (P = .01) but did not have significantly fewer days in the hospital at 12 months after baseline. Conclusion: Integrated telehealth care for older adults with chronic illness and comorbid depression can reduce symptoms and postdischarge ED use in home health settings.

Low health literacy is associated with poor outcomes in asthma and other diseases, but the mechanisms governing this relationship are not well defined.We sought to assess whether literacy is related to subsequent asthma self-management, measured as adherence to inhaled steroids, and asthma outcomes.In a prospective longitudinal cohort study, numeric (Asthma Numeracy Questionnaire) and print literacy (Short Test of Functional Health Literacy in Adults) were assessed at baseline in adults with moderate or severe asthma for their impact on subsequent electronically monitored adherence and asthma outcomes (asthma control, asthma-related quality of life, and FEV1) over 26 weeks, using mixed-effects linear regression models.A total of 284 adults participated: age, 48 ± 14 years, 71% females, 70% African American, 6% Latino, mean FEV1 66% ± 19%, 86 (30%) with hospitalizations, and 148 (52%) with emergency department visits for asthma in the prior year. Mean Asthma Numeracy Questionnaire score was 2.3 ± 1.2 (range, 0-4); mean Short Test of Functional Health Literacy in Adults score was 31 ± 8 (range, 0-36). In unadjusted analyses, numeric and print literacy were associated with better adherence (P = .01 and P = .08, respectively), asthma control (P = .005 and P.001, respectively), and quality of life (P.001 and P.001, respectively). After controlling for age, sex, and race/ethnicity, the associations diminished and only quality of life (numeric P = .03, print P = .006) and asthma control (print P = .005) remained significantly associated with literacy. Race/ethnicity, income, and educational attainment were correlated (P.001).While the relationship between literacy and health is complex, interventions that account for and address the literacy needs of patients may improve asthma outcomes.

Objectives Radical cystectomy (RC) is the standard treatment for muscle-invasive urothelial carcinoma of the bladder. Trimodality bladder-preserving therapy (BPT) is an alternative to RC, but randomized comparisons of RC versus BPT have proven infeasible. To compare RC versus BPT, we undertook an observational cohort study using registry and administrative claims data from the Surveillance, Epidemiology and End Results-Medicare database. Methods We identified patients age 65 years or older diagnosed between 1995 and 2005 who received RC (n = 1426) or BPT (n = 417). We examined confounding and stage misclassification in the comparison of RC and BPT by using multivariable adjustment, propensity score–based adjustment, instrumental variable (IV) analysis, and simulations. Results Patients who received BPT were older and more likely to have comorbid disease. After propensity score adjustment, BPT was associated with an increased hazard of death from any cause (hazard ratio [HR] 1.26; 95% confidence interval [CI] 1.05–1.53) and from bladder cancer (HR 1.31; 95% CI 0.97–1.77). Using the local area cystectomy rate as an instrument, IV analysis demonstrated no differences in survival between BPT and RC (death from any cause HR 1.06; 95% CI 0.78–1.31; death from bladder cancer HR 0.94; 95% CI 0.55–1.18). Simulation studies for stage misclassification yielded results consistent with the IV analysis. Conclusions Survival estimates in an observational cohort of patients who underwent RC versus BPT differ by analytic method. Multivariable and propensity score adjustment revealed greater mortality associated with BPT relative to RC, while IV analysis and simulation studies suggest that the two treatments are associated with similar survival outcomes.

Background For patients recovering from severe acute illness, admission to a long-term acute care hospital (LTAC) is an increasingly common alternative to continued management in an intensive care unit.

Depression and suicide are major public health concerns, and are often unrecognized among the elderly. This study investigated social inequalities in depressive symptoms and suicidal ideation among older adults.Data come from 1,226 participants in PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial), a large primary care-based intervention trial for late-life depression. Linear and logistic regressions were used to analyze depressive symptoms and suicidal ideation over the 2-year follow-up period.Mean Hamilton Depression Rating Scale (HDRS) scores were significantly higher among participants in financial strain [regression coefficient (b) = 1.78, 95 % confidence interval (CI) = 0.67-2.89] and with annual incomes below $20,000 (b = 1.67, CI = 0.34-3.00). Financial strain was also associated with a higher risk of suicidal ideation (odds ratio = 2.35, CI = 1.38-3.98).There exist marked social inequalities in depressive symptoms and suicidal ideation among older adults attending primary care practices, the setting in which depression is most commonly treated. Our results justify continued efforts to understand the mechanisms generating such inequalities and to recognize and provide effective treatments for depression among high-risk populations.

Purpose We studied the application of the generalized structural mean model (GSMM) of instrumental variable (IV) methods in estimating treatment odds ratios (ORs) for binary outcomes in pharmacoepidemiologic studies and evaluated the bias of GSMM compared to other IV methods. Methods Because of the bias of standard IV methods, including two-stage predictor substitution (2SPS) and two-stage residual inclusion (2SRI) with binary outcomes, we implemented another IV approach based on the GSMM of Vansteelandt and Goetghebeur. We performed simulations under the principal stratification setting and evaluated whether GSMM provides approximately unbiased estimates of the causal OR and compared its bias and mean squared error to that of 2SPS and 2SRI. We then applied different IV methods to a study comparing bezafibrate versus other fibrates on the risk of diabetes. Results Our simulations showed that unlike the standard logistic, 2SPS, and 2SRI procedures, our implementation of GSMM provides an approximately unbiased estimate of the causal OR even under unmeasured confounding. However, for the effect of bezafibrate versus other fibrates on the risk of diabetes, the GSMM and two-stage approaches yielded similarly attenuated and statistically non-significant OR estimates. The attenuation of the OR by the two-stage and GSMM IV approaches suggests unmeasured confounding, although violations of the IV assumptions or differences in the parameters estimated could be playing a role. Conclusion The GSMM IV approach provides approximately unbiased adjustment for unmeasured confounding on binary outcomes when a valid IV is available. Copyright © 2012 John Wiley & Sons, Ltd.

Purpose: Telehealth care is emerging as a viable intervention model to treat complex chronic conditions, such as heart failure (HF) and chronic obstructive pulmonary disease (COPD), and to engage older adults in self-care disease management. Design and Methods: We report on a randomized controlled trial examining the impact of a multifaceted telehealth intervention on health, mental health, and service utilization outcomes among homebound medically ill older adults diagnosed with HF or COPD. Random effects regression modeling was used, and we hypothesized that older adults in the telehealth intervention ( n = 51) would receive signifi cantly better quality of care resulting in improved scores in healthrelated quality of life, mental health, and satisfaction with care at 3 months follow-up as compared with controls ( n = 51) and service utilization outcomes at 12 months follow-up. Results: At follow-up, the telehealth intervention group reported greater increases in general health and social functioning, and improved in depression symptom scores as compared with usual care plus education group. The control group had signifi cantly more visits to the emergency department than the telehealth group. There was an observed trend toward fewer hospital days for telehealth participants, but it did not reach signifi cance at 12 months. Implications: Telehealth may be an effi cient and effective method of systematically delivering integrated care in the home health sector. The use of telehealth technology may benefi t homebound older adults who have diffi culty accessing care due to disability, transportation, or isolation.

Greening of vacant urban land may affect health and safety. The authors conducted a decade-long difference-indifferences analysis of the impact of a vacant lot greening program in Philadelphia, Pennsylvania, on health and safety outcomes. ‘‘Before’’ and ‘‘after’’ outcome differences among treated vacant lots were compared with matched groups of control vacant lots that were eligible but did not receive treatment. Control lots from 2 eligibility pools were randomly selected and matched to treated lots at a 3:1 ratio by city section. Random-effects regression models were fitted, along with alternative models and robustness checks. Across 4 sections of Philadelphia, 4,436 vacant lots totaling over 7.8 million square feet (about 725,000 m 2 ) were greened from 1999 to 2008. Regressionadjusted estimates showed that vacant lot greening was associated with consistent reductions in gun assaults across all 4 sections of the city (P < 0.001) and consistent reductions in vandalism in 1 section of the city (P < 0.001). Regression-adjusted estimates also showed that vacant lot greening was associated with residents’ reporting less stress and more exercise in select sections of the city (P < 0.01). Once greened, vacant lots may reduce certain crimes and promote some aspects of health. Limitations of the current study are discussed. Community-based trials are warranted to further test these findings. city planning; crime; geography; urban health; urban renewal; wounds and injuries

Objective: The heightened risk of persons with serious mental illness to contract and transmit HIV is recognized as a public health problem. Persons with HIV and mental illness may be at risk for poor treatment adherence, development of treatment-resistant virus, and worse outcomes. The objective of this study was to test the effectiveness of a communitybased advanced practice nurse (APN) intervention (PATH, Preventing AIDS Through Health) to promote adherence to HIV and psychiatric treatment regimens. Methods: Community-dwelling HIV-positive participants with co-occurring serious mental illnesses (N=238) were recruited from community HIV provider agencies from 2004 to 2008 to participate in the randomized controlled trial. Participants in the intervention group (N=128) were assigned an APN who provided community-based care management at a minimum of one visit per week and coordinated clients’ medical and mental health care for one year. Viral load and CD4 cell count were evaluated at baseline and 12 months. Results: Longitudinal models for continuous log viral load showed that compared with the control group, the intervention group exhibited a significantly greater reduction in log viral load at 12 months (d=–.361 log 10 copies per milliliter, p

BACKGROUND: Because cancers are a leading cause of death, these diseases receive a great deal of news attention. However, because news media frequently target specific racial or ethnic audiences, some populations may receive different information, and it is unknown whether reporting equally informs all audiences about the options for care at the end of life. This study of news reporting compared “mainstream” (general market) media with African American media, which serves the largest minority group. The specific goal of this study was to determine whether these news media communicate differently about cure-directed cancer treatment and end-of-life alternatives. METHODS: This content analysis included 660 cancer news stories from online and print media that targeted either African American or mainstream audiences. The main outcome measures included whether reporting discussed adverse events of cancer treatment, cancer treatment failure, cancer death/dying, and end-of-life palliative or hospice care. RESULTS: Unadjusted and adjusted analyses indicated that the news stories in the African American media are less likely than those in mainstream media to discuss each of the topics studied. Comparing the proportions of news stories in mainstream versus African American media, 31.6% versus 13.6% discussed adverse events (odds ratio [OR], 2.92; 95% confidence interval [CI], 1.51-5.66; P = .001); 14.1% versus 4.2% mentioned treatment failure (OR, 3.79; 95% CI, 1.45-9.88; P = .006); and 11.9% versus 3.8% focused on death/dying (OR, 3.42; 95% CI, 1.39-8.38; P = .007). Finally, although very few news stories discussed end-of-life hospice or palliative care, all were found in mainstream media (7/396 vs 0/264). CONCLUSION: The African American news media sampled are less likely than mainstream news media to portray negative cancer outcomes and end-of-life care. Given media's segmented audiences, these findings raise concerns that not all audiences are being informed equally well. Because media content is modifiable, there may be opportunities to improve public cancer communication. Cancer 2012. © 2011 American Cancer Society.

A case-control study of 149 intentionally self-inflicted gun injury cases (including completed gun suicides) and 302 population-based controls was conducted from 2003 to 2006 in a major US city. Two focal independent variables, acute alcohol consumption and alcohol outlet availability, were measured. Conditional logistic regression was adjusted for confounding variables. Gun suicide risk to individuals in areas of high alcohol outlet availability was less than the gun suicide risk they incurred from acute alcohol consumption, especially to excess. This corroborates prior work but also uncovers new information about the relationships between acute alcohol consumption, alcohol outlets, and gun suicide. Study limitations and implications are discussed.

Extensive research demonstrates the negative impact of maternal depression on their offspring. Unfortunately, few studies have been explored in African American families. This study examined emotional and behavioral functioning among children of African American mothers with depression. African American mothers (n = 63), with a past year diagnosis of a depressive disorder, and one of their children (ages 7–14) completed behavioral rating scales in a cross-sectional design. Results showed that 6.5% and 15% scored within the clinical range for depression and anxiety symptoms, respectively. Approximately a third of the offspring reported suicidal ideation. Based on mothers’ report, 25.4% and 20.6% of the offspring exhibited internalizing and externalizing symptoms in the clinical range, respectively. Offspring whose mothers were in treatment exhibited higher levels of self-reported anxiety symptoms Offspring of African American mothers with depression were exhibiting socioemotional problems in ways that are similar to offspring of European American mothers with depression.

The growing population of elders is increasing the attention to bipolar disorder (BD) in late life (1, 2). The scant relevant literature highlights the challenges of treating BD in older adults, including greater medical comorbidity and lower tolerance to standard pharmacotherapies than in younger patients (3-6). Evidence specific to geriatric BD is urgently needed (7, 8). While depressive symptoms contribute to reduced quality of life among BD elders (4), there are no published prospective studies of the treatment of geriatric bipolar depression. The challenge of managing bipolar depression in mixed-age populations has been highlighted by previous reports (9-12), and a limited number of medications have been shown to be efficacious for bipolar depression. In addition to the possible precipitation of mania or rapid cycling (13, 14), the addition of multiple psychotropic agents to stabilize mood and treat depression is of concern in older adults due to the risks associated with polypharmacy (15, 16). Lamotrigine was approved by the U.S. Food and Drug Administration for the treatment of epilepsy in 1994, and for the maintenance treatment of BD in 2003. Meta-analysis and meta-regression of monotherapy randomized controlled trials (RCTs) suggest minimal to modest efficacy for lamotrigine in acute bipolar depression (17, 18). However, lamotrigine is widely used in clinical settings for the treatment of bipolar depression, typically in combination with other agents. A recent study of combined lamotrigine and lithium in bipolar depression demonstrated significant improvement and good tolerability in mixed-age adults (19). A literature review and a secondary data-analysis of lamotrigine in older adults with BD (20, 21) suggest that lamotrigine is well tolerated and efficacious, with particular benefit against depressive relapse. The secondary analysis (20) focused on older adults (≥ 55 years) from two placebo-controlled, RCTs evaluating lamotrigine, lithium, and placebo in BD maintenance. There were 638 patients in the double-blind treatment phase including 98 older adults (mean age 61 years, SD = 6.0; range: 55–82 years). Lamotrigine significantly delayed time-to-intervention for depression compared with lithium, while lithium performed better than lamotrigine for time-to-intervention for mania. Side effects for both lamotrigine and lithium were generally time-limited and mild to moderate in intensity, including similar rates of skin rash (3% for lamotrigine, 5% for lithium). Given the positive prospective findings in mixed-age patients and encouraging results in the secondary analysis with older BD patients, we conducted a 12-week, open label trial of lamotrigine in adults age 60 and older with type I or II bipolar depression, assessing its dosing, tolerability, and efficacy. We hypothesized that lamotrigine would be associated with improvement in depressive symptoms and would be well tolerated by these older adults with bipolar depression.

We describe causal mediation methods for analysing the mechanistic factors through which interventions act on outcomes. A number of different mediation approaches have been presented in the biomedical, social science and statistical literature with an emphasis on different aspects of mediation. We review the different sets of assumptions that allow identification and estimation of effects in the simple case of a single intervention, a temporally subsequent mediator and outcome. These assumptions include various no confounding assumptions including sequential ignorability assumptions and also interaction assumptions involving the treatment and mediator. The understanding of such assumptions is crucial since some can be assessed under certain conditions (e.g. treatment–mediator interactions), whereas others cannot (sequential ignorability). These issues become more complex with multiple mediators and longitudinal outcomes. In addressing these assumptions, we review several causal approaches to mediation analyses.

Gildengers AG, Mulsant BH, Al Jurdi RK, Beyer JL, Greenberg RL, Gyulai L, Moberg PJ, Sajatovic M, Ten Have T, Young RC, The GERI-BD Study Group. The relationship of bipolar disorder lifetime duration and vascular burden to cognition in older adults.Bipolar Disord 2010: 12: 851–858. © 2010 The Authors. Journal compilation © 2010 John Wiley & Sons A/S. Objectives: We describe the cognitive function of older adults presenting with bipolar disorder (BD) and mania and examine whether longer lifetime duration of BD is associated with greater cognitive dysfunction. We also examine whether there are negative, synergistic effects between lifetime duration of BD and vascular disease burden on cognition. Methods: A total of 87 nondemented individuals with bipolar I disorder, age 60 years and older, experiencing manic, hypomanic, or mixed episodes, were assessed with the Dementia Rating Scale (DRS) and the Framingham Stroke Risk Profile (FSRP) as a measure of vascular disease burden. Results: Subjects had a mean (SD) age of 68.7 (7.1) years and 13.6 (3.1) years of education; 50.6% (n = 44) were females, 89.7% (n = 78) were white, and 10.3% (n = 9) were black. They presented with overall and domain-specific cognitive impairment in memory, visuospatial ability, and executive function compared to age-adjusted norms. Lifetime duration of BD was not related to DRS total score, any other subscale scores, or vascular disease burden. FSRP scores were related to the DRS memory subscale scores, but not total scores or any other domain scores. A negative interactive effect between lifetime duration of BD and FSRP was only observed with the DRS construction subscale. Conclusions: In this study, lifetime duration of BD had no significant relationship with overall cognitive function in older nondemented adults. Greater vascular disease burden was associated with worse memory function. There was no synergistic relationship between lifetime duration of BD and vascular disease burden on overall cognition function. Addressing vascular disease, especially early in the course of BD, may mitigate cognitive impairment in older age.

Background Exposure to community violence (ECV) has been associated with asthma morbidity of children living in inner-city neighborhoods. Objective To examine with prospective longitudinal data whether ECV is independently associated with asthma-related health outcomes in adults. Methods Adults with moderate-severe asthma, recruited from clinics serving inner-city neighborhoods, completed questionnaires covering sociodemographics, asthma severity, and ECV and were followed for 26 weeks. Longitudinal models were used to assess unadjusted and adjusted associations of subsequent asthma outcomes (emergency department [ED] visits, hospitalizations, FEV 1 , quality of life). Results A total of 397 adults, 47 ± 14 years old, 73% women, 70% African American, 7% Latino, mean FEV 1 66% ± 19%, 133 with hospitalizations and 222 with ED visits for asthma in the year before entry, were evaluated. Ninety-one reported ECV. Controlling for age, sex, race/ethnicity, and household income, those exposed to violence had 2.27 (95% CI, 1.32-3.90) times more asthma-related ED visits per month and 2.49 (95% CI, 1.11-5.60) times more asthma-related hospitalizations per month over the 26-week study period compared with those unexposed. Violence-exposed participants also had 1.71 (95% CI, 1.14-2.56) times more overall ED visits per month and 1.72 (95% CI, 0.95-3.11) times more overall hospitalizations per month from any cause. Asthma-related quality of life was lower in the violence-exposed participants (−0.40; 95% CI, −0.77 to −0.025; P = .04). Effect modification by depressive symptoms was only statistically significant for the ECV association with overall ED visits and quality-of-life outcomes ( P Conclusion In adults, ECV is associated with increased asthma hospitalizations and emergency care for asthma or any condition and with asthma-related quality of life.

This report considers the conceptual and methodological concerns confronting clinical investigators seeking to generate knowledge regarding the tolerability and benefits of pharmacotherapy in geriatric bipolar disorder (BD) patients.There is continuing need for evidence-based guidelines derived from randomized controlled trials that will enhance drug treatment of geriatric BD patients. Therefore, we present the complex conceptual and methodological choices encountered in designing a multisite clinical trial and the decisions reached by the investigators with the intention that study findings be pertinent to, and can facilitate, routine treatment decisions.Guided by a literature review and input from peers, the tolerability and antimanic effects of lithium and valproate were judged to be the key mood stabilizers to investigate with regard to treating bipolar I disorder manic, mixed, and hypomanic states. The patient selection criteria are intended to generate a sample that not only experiences common treatment needs but also represents the variety of older patients seen in university-based clinical settings. The clinical protocol guides titration of lithium and valproate to target serum concentrations, with lower levels allowed when necessitated by limited tolerability. The protocol emphasizes initial monotherapy. However, augmentation with risperidone is permitted after three weeks when indicated by operational criteria.A randomized, controlled trial that both investigates commonly prescribed mood stabilizers and maximizes patient participation can meaningfully address high-priority clinical concerns directly relevant to the routine pharmacologic treatment of geriatric BD patients.

In a quantitative trait locus (QTL) study, it is usually not feasible to select families with offspring that simultaneously display variability in more than one phenotype. When multiple phenotypes are of interest, the sample will, with high probability, contain ‘non-segregating’ families, i.e. families with both parents homozygous at the QTL. These families potentially reduce the power of regression-based methods to detect linkage. Moreover, follow-up studies in individual families will be inefficient, and potentially even misleading, if non-segregating families are selected for the study. Our work extends Haseman-Elston regression using a latent class model to account for the mixture of segregating and non-segregating families. We provide theoretical motivation for the method using an additive genetic model with two distinct functions of the phenotypic outcome, squared difference (SqD) and mean-corrected product (MCP). A permutation procedure is developed to test for linkage; simulation shows that the test is valid for both phenotypic functions. For rare alleles, the method provides increased power compared to a ‘marginal’ approach that ignores the two types of families; for more common alleles, the marginal approach has better power. These results appear to reflect the ability of the algorithm to accurately assign families to the two classes and the relative weights of segregating and non-segregating families to the test of linkage. An application of Bayes rule is used to estimate the family-specific probability of segregating. High predictive value positive values for segregating families, particularly for MCP, suggest that the method has considerable value for identifying segregating families. The method is illustrated for gene expression phenotypes measured on 27 candidate genes previously demonstrated to show linkage in a sample of 14 families.

Objectives To describe charges associated with primary video-assisted thoracoscopic surgery and primary chest tube placement in a multicenter cohort of children with empyema and to determine whether pleural fluid drainage by primary video-assisted thoracoscopic surgery was associated with cost-savings compared with primary chest tube placement.

Objectives: A range of psychiatric symptoms and cognitive deficits occur in Parkinson disease (PD), and symptom overlap and comorbidity complicate the classification of nonmotor symptoms. The objective of this study was to use analytic-based approaches to classify psychiatric and cognitive symptoms in PD. Design: Cross-sectional evaluation of a convenience sample of patients in specialty care. Setting: Two outpatient movement disorders centers at the University of Pennsylvania and Philadelphia Veterans Affairs Medical Center. Participants: One hundred seventy-seven patients with mild-moderate idiopathic PD and without significant global cognitive impairment. Measurements: Subjects were assessed with an extensive psychiatric, neuropsychological, and neurological battery. Latent class analysis (LCA) was used to statistically delineate group-level symptom profiles across measures of psychiatric and cognitive functioning. Predictors of class membership were also examined. Results: Results from the LCA indicated that a four-class solution best fit the data. The 32.3% of the sample had good psychiatric and normal cognitive functioning, 17.5% had significant psychiatric comorbidity but normal cognition, 26.0% had few psychiatric symptoms but had poorer cognitive functioning across a range of cognitive domains, and 24.3% had both significant psychiatric comorbidity and poorer cognitive functioning. Age, disease severity, and medication use predicted class membership. Conclusions: LCA delineates four classes of patients in mild-moderate PD, three of which experience significant nonmotor impairments and comprise over two thirds of patients. Neuropsychiatric symptoms and cognitive deficits follow distinct patterns in PD, and further study is needed to determine whether these classes are generalizable, stable, predict function, quality of life, and long-term outcomes and are amenable to treatment at a class level.

Purpose To examine the effect of antihypertensive adherence on blood pressure and barriers to adherence in racially diverse elderly patients. Methods Telephone survey of a representative sample of 300 of all 3416 hypertensive patients aged >70 from four urban primary care practices. From electronic records, we calculated subjects' annual mean systolic blood pressure. We asked about the last missed antihypertensive dose in six time intervals. Based on association with blood pressure control, non-adherence was defined as missing any dose in the past 3 months. Subjects were also asked about six domains of adherence barriers: health, personal support, drug coverage, medication filling and use, doctor–patient interaction and knowledge. All models adjust for demographics, treatment regimen and sampling weights. Results The 202 subjects (67% response rate) were: female (65.9%), black (64.8%), mean age 77.4 years (5.49) and on mean 2.4 (SD 1.3) antihypertensive drugs. Mean annual systolic pressure for non-adherent subjects (22% of the cohort) was higher than adherent subjects (137.7 vs.133.4 mmHg, p = 0.065). After adjustment, the association between adherence and blood pressure was stronger in black than white patients (p = 0.007). In an initial model, being unaware of Medicare Part D had a lower adjusted odds ratio (AOR) of adherence (p

OBJECTIVES: To estimate the effect of an evidence-based depression care management (DCM) intervention on the initiation and appropriate use of antidepressant in primary care patients with late-life depression. DESIGN: Secondary analysis of data from a randomized trial. SETTING: Community, primary care. PARTICIPANTS: Randomly selected individuals aged 60 and older with routine appointments at 20 primary care clinics randomized to provide a systematic DCM intervention or care as usual. METHODS: Rates of antidepressant use and dose adequacy of patients in the two study arms were compared at each patient assessment (baseline, 4, 8, and 12 months). For patients without any antidepressant treatment at baseline, a longitudinal analysis was conducted using multilevel logistic models to compare the rate of antidepressant treatment initiation, dose adequacy when initiation wasfirst recorded, and continued therapy for at least 4 months after initiation between study arms. All analyses were conducted for the entire sample and then repeated for the subsample with major or clinically significant minor depression at baseline. RESULTS: Rates of antidepressant use and dose adequacy increased over the first year in patients assigned to the DCM intervention, whereas the same rates held constant in usual care patients. In longitudinal analyses, the DCM intervention had a significant effect on initiation of antidepressant treatment (adjusted odds ratio (OR) 55.63, Po.001) and continuation of antidepressant medication for at least 4 months (OR 56.57, P 5.04) for patients who were depressed at baseline. CONCLUSIONS: Evidence-based DCM models are highly effective at improving antidepressant treatment in older primary care patients. J Am Geriatr Soc 57:895–900, 2009.

Objective: To develop a better understanding of how men react to being diagnosed with prostate cancer and identify factors that influence these responses, we conducted an observational study to identify sociocultural predictors of men's psychological reactions. Methods: Participants were 70 African American and 124 white prostate cancer patients who completed a structured telephone interview that evaluated psychological reactions in terms of intrusive thoughts about cancer and attempts to avoid cancer-related thoughts and feelings. Perceptions of disease-specific stress, cultural beliefs and values, and social constraints were also assessed during the interview. Results: There were no racial differences in men's reactions to being diagnosed with prostate cancer; however, greater perceptions of disease-specific stress, increasing levels of present temporal orientation, and more social constraints had significant positive effects on avoidant reactions. Greater perceptions of stress also had a significant positive effect on intrusive thoughts. Conclusions: The results of this study highlight the need for individualized approaches to help men address their thoughts and feelings about being diagnosed with prostate cancer. These efforts should include strategies that help men to communicate more effectively with social support resources and address cultural beliefs and values related to temporal orientation. Copyright © 2009 John Wiley & Sons, Ltd.

This article considers the problem of assessing causal effect moderation in longitudinal settings in which treatment (or exposure) is time varying and so are the covariates said to moderate its effect. Intermediate causal effects that describe time-varying causal effects of treatment conditional on past covariate history are introduced and considered as part of Robins' structural nested mean model. Two estimators of the intermediate causal effects, and their standard errors, are presented and discussed: The first is a proposed two-stage regression estimator. The second is Robins' G-estimator. The results of a small simulation study that begins to shed light on the small versus large sample performance of the estimators, and on the bias-variance trade-off between the two estimators are presented. The methodology is illustrated using longitudinal data from a depression study.

In this article, we present a discussion of two general ways in which the traditional randomized trial can be modified or adapted in response to the data being collected. We use the term adaptive design to refer to a trial in which characteristics of the study itself, such as the proportion assigned to active intervention versus control, change during the trial in response to data being collected. The term adaptive sequence of trials refers to a decision-making process that fundamentally informs the conceptualization and conduct of each new trial with the results of previous trials. Our discussion below investigates the utility of these two types of adaptations for public health evaluations. Examples are provided to illustrate how adaptation can be used in practice. From these case studies, we discuss whether such evaluations can or should be analyzed as if they were formal randomized trials, and we discuss practical as well as ethical issues arising in the conduct of these new-generation trials.

Research that seeks to enroll noncompetent patients with Alzheimer's disease without presenting any potential benefit to participants is the source of substantial ethical controversy. The authors used hypothetical Alzheimer's disease studies that included either a blood draw or a blood draw and lumbar puncture to explore older persons' attitudes on this question.Face-to-face interviews were conducted with 538 persons age 65 and older. Questions explored participants' understanding of research concepts, their views on enrolling persons with Alzheimer's disease in research, and their preferences regarding having a proxy decision maker, granting advance consent, and granting their proxy leeway to override the participant's decision. Additional questions assessed altruism, trust, value for research, and perceptions of Alzheimer's disease.The majority (83%) were willing to grant advance consent to a blood draw study, and nearly half (48%) to a blood draw plus lumbar puncture study. Most (96%) were willing to identify a proxy for research decision making, and most were willing to grant their proxy leeway over their advance consent: 81% for the blood draw study and 70% for the blood draw plus lumbar puncture study. Combining the preferences for advance consent and leeway, the proportion who would permit being enrolled in the blood draw and lumbar puncture studies, respectively, were 92% and 75%. Multivariate models showed that willingness to be enrolled in research was most strongly associated with a favorable attitude toward biomedical research.Older adults generally support enrolling noncompetent persons with Alzheimer's disease into research that does not present a benefit to subjects. Willingness to grant their proxy leeway over advance consent and a favorable attitude about biomedical research substantially explain this willingness.

The dual risk of exposure to community violence and maternal depression has potentially negative effects on children. This study examined whether social skills served as a protective factor for the impact of community violence exposure on anxiety within children of African American mothers with depression. Multiple regressions showed that community violence exposure was associated with less anxious coping but more physical symptoms. Findings support that younger children who view themselves as being socially skilled also exhibit higher levels of anxious coping. Implications addressing the importance of age, physical symptoms of anxiety, and anxious vigilance for interventions are discussed.