Lifestyle Modification in Blood Pressure Study II (LIMBS): study protocol of a randomized controlled trial assessing the efficacy of a 24 week structured yoga program versus lifestyle modification on blood pressure reduction.

Hypertension is a major public health issue affecting 68 million adults in the United States. Lifestyle modifications including complementary therapies such as the movement based mind body practice of yoga have become increasingly popular in the United States and have been considered as a potential alternative to medication in blood pressure reduction. We completed a pilot study in 2009 which showed meaningful decreases in 24-hour ambulatory blood pressure readings after a 12 week period of yoga participation. Based on data from our pilot study we are now completing The Lifestyle Modification and Blood Pressure Study (LIMBS II) which is a phase 2 randomized controlled trial designed to determine the effects of yoga therapy and enhanced lifestyle modification on lowering blood pressure in pre-hypertensive and stage 1 hypertensive subjects. Using 24-hour ambulatory blood pressure monitoring, LIMBS II aims to compare the effects on blood pressure reduction in subjects randomized for 24 weeks to one of the three following groups: yoga therapy versus blood pressure education program (sodium restriction and walking program) versus a combination program that involves components of both groups. LIMBS II will also examine the impact that changes in blood pressure have on cerebral blood flow. If successful, the LIMBS study will determine if yoga therapy combined with enhanced lifestyle modification will result in clinically meaningful decreases in blood pressure and thus can be implemented as an alternative to drug therapy for patients with prehypertension and stage 1 hypertension.

Methods for linking community views to measureable outcomes in a youth violence prevention program.

BACKGROUND: All parties in community-academic partnerships have a vested interest prevention program success. Markers of success that reflect community's experiences of programmatic prevention success are not always measurable, but critically speak to community-defined needs. OBJECTIVE: The purpose of this manuscript was to (1) describe our systematic process for linking locally relevant community views (community-defined indicators) to measurable outcomes in the context of a youth violence prevention program and (2) discuss lessons learned, next steps, and recommendations for others trying to replicate a similar process. METHODS: A research team composed of both academic and community researchers conducted a systematic process of matching community-defined indicators of youth violence prevention programmatic success to standardized youth survey items being administered in the course of a program evaluation. The research team of three community partners and five academic partners considered 43 community-defined indicators and 208 items from the youth surveys being utilized within the context of a community-based aggression prevention program. At the end of the matching process, 92 youth survey items were identified and agreed upon as potential matches to 11 of the community-defined indicators. CONCLUSIONS: We applied rigorous action steps to match community-defined indicators to survey data collected in the youth violence prevention intervention. We learned important lessons that inform recommendations for others interested in such endeavors. The process used to derive and assess community-defined indicators of success emphasized the principles of community-based participatory research (CBPR) and use of existing and available data to reduce participant burden.

The impact of 24-hr, in-hospital pediatric critical care attending physician presence on process of care and patient outcomes*.

OBJECTIVE: Attending physicians are only required to provide in-hospital coverage during daytime hours in many pediatric intensive care units. An in-hospital 24-hr pediatric intensive care unit attending coverage model has been increasingly popular, but the impact of 24-hr, in-hospital attending coverage on care processes and outcomes has not been reported. We compared processes of care and outcomes before and after the implementation of a 24-hr in-hospital pediatric intensive care unit attending physician model. DESIGN: Retrospective comparison of before and after cohorts. SETTING: A single large, academic tertiary medical/surgical pediatric intensive care unit. PATIENTS: : Pediatric intensive care unit admissions in 2000-2006. INTERVENTION: Transition to 24-hr from 12-hr in-hospital pediatric critical care attending physician coverage model in January 2004. MEASUREMENTS AND MAIN RESULTS: A total of 18,702 patients were admitted to intensive care unit: 8,520 in 24 hrs; 10,182 in 12 hrs. Duration of mechanical ventilation was lower (median 33 hrs [interquartile range 12-88] vs. 48 hrs [interquartile range 16-133], adjusted reduction of 35% [95% confidence interval 25%-44%], p < .001) and intensive care unit length of stay was shorter (median 2 days [interquartile range 1-4] vs. 2 days [interquartile range 1-5], adjusted p < .001) for 24 hr vs. 12 hr coverage. The reduction in mechanical ventilation hours was similar when noninvasive, mechanical ventilation was included in ventilation hours (median 42 hrs vs. 56 hrs, adjusted reduction in ventilation hours: 33% [95% confidence interval 20-45], p < .001). Intensive care unit mortality was not significantly different (2.2% vs. 2.5%, adjusted p =.23). These associations were consistent across daytime and nighttime admissions, weekend and weekday admissions, and among subgroups with higher Pediatric Risk of Mortality III scores, postsurgical patients, and histories of previous intensive care unit admission. CONCLUSIONS: Implementation of 24-hr in-hospital pediatric critical care attending coverage was associated with shorter duration of mechanical ventilation and shorter length of intensive care unit stay. After accounting for potential confounders, this finding was consistent across a broad spectrum of critically ill children.

Effect of rotavirus vaccine on reducing acute gastroenteritis in a large outpatient pediatric network.

OBJECTIVES: To measure the effect of rotavirus vaccine (RVV) on acute gastroenteritis (AGE) managed by primary care physicians in the first 2 rotatvirus seasons following the introduction of RVV. DESIGN: Retrospective cohort study. SETTING: Practice-based network composed of 33 ambulatory pediatric practices in Philadelphia, Pennsylvania. PARTICIPANTS: All children born from February 22, 2006 (date of RVV licensure), through February 29, 2008, and who received care at any network site. MAIN EXPOSURE: Receipt of RVV. OUTCOME MEASURES: The primary outcomes were AGE-related office visits, telephone calls, and episodes (composite outcome consisting of all visits and calls within a 10-day period). RESULTS: Rates of AGE visits in the 2 rotavirus seasons following the introduction of RVV steadily decreased from 3.0 AGE visits per 100 total office visits in the 2005 season to 1.8 in the 2008 season. In 2007, vaccinations were administered to 9351 of 13 951 vaccine-eligible children (67.0%), and in 2008, they were administered to 9958 of 10 728 (92.8%). Among RVV-immunized children in 2007, AGE calls and episodes were significantly reduced with vaccine effectiveness of 53% and 46%, respectively. No significant difference was seen between RVV-immunized and RVV-nonimmunized children for any outcome in 2008. CONCLUSIONS: Rotavirus vaccine was associated with a significant reduction in outpatient AGE calls and episodes among immunized children in our network in 2007. Despite a reduction in winter AGE rates in the network, no difference was detected between RVV-immunized and RVV-nonimmunized children for any outcome in 2008. Further study is needed to understand the lack of vaccine effect in 2008.

Response to antimalarial agents in cutaneous lupus erythematosus: a prospective analysis.

OBJECTIVE: To demonstrate response to antimalarial agents in patients with cutaneous lupus erythematosus (CLE) using activity scores from the Cutaneous Lupus Erythematosus Disease Area and Severity Index, a validated outcome measure. DESIGN: Prospective, longitudinal cohort study. SETTING: University cutaneous autoimmune disease clinic. PARTICIPANTS: A total of 128 patients with CLE who presented from January 2007 to July 2010 and had at least 2 visits with activity scores. INTERVENTION: Administration of antimalarial agents. MAIN OUTCOME MEASURES: Response was defined by a 4-point or 20% decrease in activity score. Response to initiation was determined by the difference between the scores before treatment and at the first visit at least 2 months after treatment. Response to continuation was determined by the difference between the scores at the first visit and the most recent visit while undergoing treatment. RESULTS: Of 11 patients who initiated treatment with hydroxychloroquine, 55% were responders (n = 6), showing a decrease in median (interquartile range [IQR]) activity score from 8.0 (3.5-13.0) to 3.0 (1.8-7.3) (P = .03). Of 15 patients for whom hydroxychloroquine failed, 67% were responders to initiation of hydroxychloroquine-quinacrine therapy (n = 10), showing a decrease in median (IQR) activity score from 6.0 (4.8-8.3) to 3.0 (0.75-5.0) (P = .004). Nine of 21 patients who continued hydroxychloroquine treatment (43%), and 9 of 21 patients who continued hydroxychloroquine-quinacrine (43%) were responders, showing a decrease in median (IQR) activity score from 6.0 (1.5-9.5) to 1.0 (0.0-4.5) (P = .01) and 8.5 (4.25-17.5) to 5.0 (0.5-11.5) (P = .01), respectively. CONCLUSIONS: The use of quinacrine with hydroxychloroquine is associated with response in patients for whom hydroxychloroquine monotherapy fails. Further reduction in disease activity can be associated with continuation of treatment with antimalarial agents.

Predictors of suicide relative to other deaths in patients with suicide attempts and suicide ideation: a 30-year prospective study.

BACKGROUND: Although there is a large literature that prospectively examines predictors of suicide, low base rates of suicide and imprecision of measurement hinder definitive conclusions from being drawn. METHOD: This study examined predictors of suicide relative to other types of death in a sample of 297 patients who had been hospitalized for suicide ideation or a suicide attempt between 1970 and 1975 and who were confirmed dead in 2005. Many predictors were measured using well-validated assessment instruments. RESULTS: Fifty-five patients had died by suicide. Univariate predictors of an increased risk for eventual suicide included younger age, completion of at least a high school degree, a diagnosis of a psychotic disorder, taking active precautions against discovery during the attempt, and a non-zero score on the suicide item of the Beck Depression Inventory, whereas African American ethnicity was associated with a decreased risk of eventual suicide. Variables that remained significant in a multivariate analysis included younger age, African American ethnicity, and taking active precautions against discovery during the attempt. Risk factors did not vary as a function of whether eventual suicide occurred less than or more than five years after the initial evaluation or by attempter v. ideator status. LIMITATIONS: Despite the attempt to maximize statistical power by following a high-risk sample for 30 years, the number of deaths by suicide was still relatively low. CONCLUSIONS: Taking active precautions against discovery of a suicide attempt has the potential to be an important predictor of eventual suicide and should be assessed by clinicians. Future prospective studies should assess predictors at multiple time points to gain a richer clinical picture of the circumstances surrounding deaths by suicide.

Depression symptom ratings in geriatric patients with bipolar mania.

OBJECTIVE: Given the paucity of information available regarding standardized ratings of depression symptoms in bipolar manic states, and in particular those in older adults, we explored depression ratings in symptomatic participants in a multicenter study of treatment of bipolar I disorder in late life. METHODS: Baseline data was obtained from the first 100 patients enrolled in an NIMH-funded, 9-week, randomized, double-blind RCT comparing treatment with lithium or valproate in patients of age 60 years and older with Type I Bipolar mania or hypomania. This multi-site study was conducted at six academic medical centers in the United States and enrolled inpatients and outpatients with a total Young Mania Rating Scale (YMRS) score of 18 or greater. Depressive symptoms were evaluated with the Hamilton Depression Rating Scale (HAM-D) and the Montgomery-Asberg Depression Rating Scale (MADRS). The criterion for at least moderate bipolar depressive symptoms was the European College of Neuropsychopharmacology (ECNP) Consensus Meeting definition of HAM-D 17 total score >20. RESULTS: Eleven percent of patients had mixed symptoms defined by depression scale severity according to ECNP criterion. In the overall sample, total scores on the two depression scales were highly correlated. Total YMRS scores of this mixed symptom group were similar to the remainder of the sample. CONCLUSIONS: These preliminary findings suggest that moderate to severe depressive symptoms occur in about one in ten bipolar manic elders. Future studies are needed to further evaluate symptom profiles, clinical correlates, and treatments for bipolar older adults with combined manic and depressive symptoms.

Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial.

BACKGROUND: Previous studies comparing low-carbohydrate and low-fat diets have not included a comprehensive behavioral treatment, resulting in suboptimal weight loss. OBJECTIVE: To evaluate the effects of 2-year treatment with a low-carbohydrate or low-fat diet, each of which was combined with a comprehensive lifestyle modification program. DESIGN: Randomized parallel-group trial. (ClinicalTrials.gov registration number: NCT00143936) SETTING: 3 academic medical centers. PATIENTS: 307 participants with a mean age of 45.5 years (SD, 9.7 years) and mean body mass index of 36.1 kg/m(2) (SD, 3.5 kg/m(2)). INTERVENTION: A low-carbohydrate diet, which consisted of limited carbohydrate intake (20 g/d for 3 months) in the form of low-glycemic index vegetables with unrestricted consumption of fat and protein. After 3 months, participants in the low-carbohydrate diet group increased their carbohydrate intake (5 g/d per wk) until a stable and desired weight was achieved. A low-fat diet consisted of limited energy intake (1200 to 1800 kcal/d;

TOWARDS PATIENT-CENTERED CARE FOR DEPRESSION: CONJOINT METHODS TO TAILOR TREATMENT BASED ON PREFERENCES.

BACKGROUND: Although antidepressants and counseling have been shown to be effective in treating patients with depression, non-treatment or under-treatment for depression is common especially among the elderly and minorities. Previous work on patient preferences has focused on medication versus counseling, but less is known about the value patients place on attributes of medication and counseling. OBJECTIVE: Conjoint analysis has been recognized as a valuable means of assessing patient treatment preferences. We examine how conjoint analysis be used to determine the relative importance of various attributes of depression treatment at the group level as well as to determine the range of individual-level relative preference weights for specific depression treatment attributes. In addition we use conjoint analysis to predict what modifications in treatment characteristics are associated with a change in the stated preferred alternative. STUDY DESIGN: 86 adults who participated in an internet-based panel responded to an on-line discrete choice task about depression treatment. Participants chose between medication and counseling based on choice sets presented first for a "mild depression" scenario and then for a "severe depression" scenario. Participants were given 18 choice sets which varied for medication based on type of side effect (nausea, dizziness, and sexual dysfunction) and severity of side effect (mild, moderate, and severe); and for counseling based on frequency of counseling sessions (once per week or every other week) and location of the sessions (mental health professional's office, primary care doctor's office or office of a spiritual counselor). RESULTS: Treatment type (counseling vs. medication) appeared to be more important in driving treatment choice than any specific attribute that was studied. Specifically counseling was preferred by most of the respondents. After treatment type, location of treatment and frequency of treatment were important considerations. Preferred attributes were similar in both the mild and severe depression scenarios. Side effect severity appeared to be most important in driving treatment choice as compared with the other attributes studied. Individual-level relative preferences for treatment type revealed a distribution that was roughly bimodal with 27 participants who had a strong preference for counseling and 14 respondents who had a strong preference for medication. CONCLUSION: Estimating individual-level preferences for treatment type allowed us to see the variability in preferences and determine which participants had a strong affinity for medication or counseling.

Lack of association between retrospectively collected pharmacy refill data and electronic drug monitoring of antiretroviral adherence.

Antiretroviral medication refill adherence has not been compared directly to electronic drug monitoring (EDM) in any identifiable published study. We retrospectively studied adults with undetectable HIV titers on highly active antiretroviral therapy. We used Pearson correlation coefficients and receiver operating characteristic curves to relate the two adherence measures, and we used the Wilcoxon rank-sum test to assess the relation between adherence and viral load. In sixty-five subjects, the majority of whom were African American and male with median age of 44 years, pharmacy refill adherence was difficult to collect retrospectively, was not significantly correlated with EDM adherence, and was not significantly related to viral load. Ninety-day supply pharmacy refill adherence correctly classified 95% EDM adherence maximally at 94 days between refills, and the measure was most sensitive for non-adherence at <90 days. Reassessment of the relation between pharmacy refill data and EDM would be warranted when pharmacy refill data is collected as soon as feasible from sources with complete data capture.

Previously undetected metabolic syndromes and infectious diseases among psychiatric inpatients.

OBJECTIVE: This study identified previously undetected metabolic and infectious disease among persons with serious mental illness who were admitted to psychiatric inpatient units. METHODS: Observational-naturalistic methods were used to simulate universal screening in order to document evidence of undetected disease among 588 adult psychiatric patients. Data were obtained from medical records and laboratory tests. RESULTS: Laboratory results showed that 10% of patients had HIV, 32% had hepatitis B, and 21% had hepatitis C. Glucose levels were elevated in 7%, and total cholesterol levels were elevated in 22%. Nearly 60% had body mass indices above 25. The treatment team missed a considerable proportion of infectious disease (95% of hepatitis B cases, 50% of hepatitis C cases, and 21% of HIV cases) and metabolic disorders (89% of cases with elevated total cholesterol levels and 97% of cases with elevated triglyceride levels). By contrast, only 18% of cases with elevated glucose levels were missed. CONCLUSIONS: This study demonstrated very high prevalence of both metabolic disorders and infectious diseases in a psychiatric inpatient population.

Mediation analysis: a retrospective snapshot of practice and more recent directions.

R. Baron and D. A. Kenny's (1986) paper introducing mediation analysis has been cited over 9,000 times, but concerns have been expressed about how this method is used. The authors review past and recent methodological literature and make recommendations for how to address 3 main issues: association, temporal order, and the no omitted variables assumption. The authors briefly visit the topics of reliability and the confirmatory-exploratory distinction. In addition, to provide a sense of the extent to which the earlier literature had been absorbed into practice, the authors examined a sample of 50 articles from 2002 citing R. Baron and D. A. Kenny and containing at least 1 mediation analysis via ordinary least squares regression. A substantial proportion of these articles included problematic reporting; as of 2002, there appeared to be room for improvement in conducting such mediation analyses. Future literature reviews will demonstrate the extent to which the situation has improved.

A randomized controlled trial of a close monitoring program for minor depression and distress.

BACKGROUND: Minor depression is almost twice as common in primary care (PC) as major depression. Despite the high prevalence, few evidence-based algorithms exist for managing patients with minor depression or patients presenting solely with distress. OBJECTIVES: The aim of this study was to test the effectiveness of a telephone-based close monitoring program to manage PC patients with minor depression or distress. DESIGN: Subjects were randomly assigned to either the control arm (usual care; UC) or the intervention arm (close monitoring; CM). We hypothesized that those randomized to CM would exhibit less depression and be less likely to have symptoms progress to the point of meeting diagnostic criteria. SUBJECTS: Overall, 223 PC subjects with minor depression or distress consented to participation in this trial. MEASUREMENTS: At baseline, subjects completed a telephone-based evaluation comprised of validated diagnostic assessments of depression and other MH disorders. Outcomes were assessed at six months utilizing this same battery. Chart reviews were conducted to track care received, such as prescribed antidepressants and MH and primary care visits. RESULTS: Subjects in the CM arm exhibited fewer psychiatric diagnoses than those in the UC arm (chi(2) = 4.04, 1 df, p = 0.04). In addition, the intervention group showed improved overall physical health (SF-12 PCS scores) (M = 45.1, SD = 11.8 versus M = 41.5, SD = 12.4) (chi(2) = 5.90, 1 df, p = .02). CONCLUSIONS: Those randomized to CM exhibited less MH problems at the conclusion of the trial, indicating that the close monitoring program is effective, feasible and valuable. The findings of this study will allow us to enhance clinical care and support the integration of mental health services and primary care.

Mediators of telephone-based continuing care for alcohol and cocaine dependence.

A previous randomized trial with 224 alcohol and/or cocaine addicts who had completed an initial phase of treatment indicated that 12 weeks of telephone-based continuing care yielded higher abstinence rates over 24 months than did group counseling continuing care. The current study examined mediators of this treatment effect. Results suggested that self-help involvement during treatment and self-efficacy and commitment to abstinence 3 months after treatment mediated subsequent abstinence outcomes. These analyses controlled for substance use prior to the assessment of mediators. Conversely, there was no evidence that self-help beliefs or social support mediated the treatment effect. These results are consistent with a model in which treatment effects are first accounted for by changes in behavior, followed by changes in self-efficacy and in commitment to abstinence.

An extension of the Early Treatment Diabetic Retinopathy Study (ETDRS) system for grading of diabetic macular edema in the Astemizole Retinopathy Trial.

PURPOSE: To compare the effects of astemizole, an antihistamine, versus placebo on the 1-year course of diabetic macular edema (DME) and to illustrate use of a modified ETDRS system for grading areas of retinal thickening and hard exudates that may be useful in clinical trials of treatments for this disorder. METHODS: Between June 1994 and September 1997, at 2 clinics, 63 patients who had, in at least one eye (the study eye), DME that had not previously been treated with macular photocoagulation, and for which photocoagulation was not currently recommended by the investigator, were enrolled and randomly assigned to astemizole or placebo. Fifty-four of the 63 patients (86%, 26 in Clinic 1 and 28 in Clinic 2) completed 1 year of followup and had adequate 7-field stereoscopic film-based color fundus photographs of the study eye at the baseline and 1-year visits. DME was > 0.33 disc diameters (DD) from the center of the macula in 48% of study eyes and involved the center in 13%. Photographs were graded using the ETDRS protocol modified to allow estimates of areas of retinal thickening (RT) and hard exudate (HE) to be made on continuous scales in disc area (DA) units. Principal outcome measures were mean change in the square root of RT area (the average diameter of the area in DD), mean change in area of HE, and change in the degree to which RT involved or threatened the center of the macula. RESULTS: At baseline, RT area in the 54 study eyes ranged from 0.09 to 4.0 DA (median 1.1). At the 1-year visit the square root of RT area (RTdd) had decreased by > or= 0.3 DD in 10 eyes, increased by >or = 0.3 DD in 19 and was about the same in 25. Mean change at 1 year was +0.09 DD (SD 0.57) for astemizole versus +0.19 DD (SD 0.48) for placebo, for a difference of -0.10 DD (95% CI -0.38, +0.19; p = 0.51). Adjustments for baseline and time-dependent risk factors did not change this result appreciably, although there was a trend towards a difference in favor of astemizole in the subgroup of patients with more severe retinopathy. Other morphologic outcomes paralleled change in RTdd. Change in RTdd did vary by clinic: -0.03 DD in Clinic 2, versus + 0.32 DD in Clinic 1, for a difference of -0.35 DD (95% CI -0.62, -0.07; p = 0.014). Clinic 1 is a tertiary retinal referral center in Pennsylvania and Clinic 2 a retinal clinic closely affiliated with a large diabetes clinic in Copenhagen. The unexpected clinic difference in outcome provided an opportunity for further analyses using the modified ETDRS system. In comparison to Clinic 1, Clinic 2 patients were more often male, were younger at diagnosis of diabetes, and had less severe retinopathy and better visual acuity, but these differences did not appear to explain the trend for lesser increase in RTdd. CONCLUSION: No effect of astemizole was found, but the confidence interval for the principal outcome, mean change in RTdd, included both a modest beneficial effect and a small harmful effect. This outcome measure did demonstrate a small difference in outcome by clinic, which could not be explained by baseline characteristics but may reflect differences in access to and/or continuity of care or other unmeasured differences associated with different referral patterns. Although optical coherence tomography may supplant photography as a measure of central RT, photographic assessments of change in RT and HE areas analyzed with the methods described herein may be useful outcomes in trials assessing treatment of early stages of DME. Application of these methods to other data sets is needed to confirm this conclusion.

Simvastatin causes changes in affective processes in elderly volunteers.

OBJECTIVES: To test for simvastatin-induced changes in affect and affective processes in elderly volunteers. DESIGN: Randomized, clinical trial. SETTING: The Geriatric Behavioral Psychopharmacology Laboratory at the University of Pennsylvania. PARTICIPANTS: Eighty older volunteers, average age 70, with high normal/mildly elevated serum cholesterol. INTERVENTION: Simvastatin up to 20 mg/d or placebo for 15 weeks. MEASUREMENTS: Daily diary records of positive and negative affects and of events and biweekly measures of depressive symptoms. Affect ratings were obtained using the Lawton positive and negative affect scales; independent raters coded the valences of events. RESULTS: Thirty-one of 39 subjects assigned to placebo and 33 of 41 receiving simvastatin completed the study. During biweekly assessments, four subjects on simvastatin and one on placebo experienced depressive symptoms, as manifest by Center for Epidemiological Studies Depression scale scores greater than 16 (exact P=.36). Diary data demonstrated significant effects on affective processes. For positive affect, there was a significant medication-by-time interaction that reflected decreases in positive affect in subjects receiving simvastatin, greatest in those patients whose final total cholesterol levels were below 148 mg/dL. For negative affect, there were significant medication-by-event, and medication-by-event-by-time interactions, reflecting a time-limited increase in the apparent effect of negative events. CONCLUSION: Simvastatin has statistically significant effects on affect and affective processes in elderly volunteers. The decrease in positive affect may be significant clinically and relevant to the quality of life of many patients.

Influences of earlier adherence and symptoms on current symptoms: a marginal structural models analysis.

BACKGROUND: The morbidity and mortality associated with asthma are suspected to be a result, in part, of poor adherence to inhaled corticosteroid regimens. One influence on adherence may be the perception of symptoms. Because symptoms and adherence affect each other over time, a conventional statistical approach for studying these relationships may provide biased results. OBJECTIVE: To understand the influence of previous asthma symptoms and previous adherence on current symptoms. METHODS: A total of 76 adults, mean age 48 years +/- 15 years, with moderate or severe persistent asthma underwent 6 weeks of electronic monitoring of their use of inhaled corticosteroids and completed a daily symptom diary. We estimated the effect of earlier adherence on final symptoms by using marginal structural models, estimated by using a weighted estimation technique. RESULTS: Morning was better than evening adherence, which declined over the observation period. The variability of adherence appeared to increase over the observation period. In addition, earlier adherence predicted current adherence more strongly than earlier symptoms predicted current adherence. There was no overall significant relationship between cumulative adherence and final symptoms. CONCLUSION: These data indicate that accurately determining past adherence will help identify patients to target to improve their future adherence. These analyses are important for understanding time-varying measures in the clinical setting.

Treatment effects from UPBEAT: a randomized trial of care management for behavioral health problems in hospitalized elderly patients.

The purpose of this study was to examine the impact of the Unified Psychogeriatric Biopsychosocial Evaluation and Treatment (UPBEAT) Program, an interdisciplinary mental health care management program, on the behavioral health symptoms of elderly veterans. Participants, 60 years and older, included 2637 veterans recruited from medical/surgical units who screened positively for significant depressive or anxiety symptoms and/or at-risk alcohol drinking. Participants were randomized to UPBEAT or to usual care. Primary outcomes were measured at baseline and at 6, 12, and 24 months. Participant nonadherence to the protocol was common and is a major limitation. There were no differences between UPBEAT and usual care patients on symptom or functional outcomes at any follow-up point. Exploratory analyses suggested that among participants with more physical health problems, there were greater improvements in depressive symptoms in those assigned to UPBEAT care. Despite a theoretical and practically sound intervention, participation was low and treatment outcomes, while generally good, appeared unaffected by the addition of the program.