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Purpose: We wanted to evaluate novel decision aids designed to help patients trust and accept the controversial, evidence-based, US Preventive Services Task Force recommendations about prostate cancer screening (from 2012) and mammography screening for women aged 40 to 49 years (from 2009).Methods: We created recorded vignettes of physician-patient discussions about prostate cancer screening and mammography, accompanied by illustrative slides, based on principles derived from preceding qualitative work and behavioral science literature. We conducted a randomized crossover study with repeated measures with 27 men aged 50 to 74 years and 35 women aged 40 to 49 years. All participants saw a video intervention and a more traditional, paper-based decision aid intervention in random order. At entry and after seeing each intervention, they were surveyed about screening intentions, perceptions of benefits and harm, and decisional conflict.Results: Changes in screening intentions were analyzed without regard to order of intervention after an initial analyses showed no evidence of an order effect. At baseline, 69% of men and 86% of women reported wanting screening, with 31% and 6%, respectively, unsure. Mean change on a 3-point, yes, unsure, no scale was -0.93 (P = <.001) for men and -0.50 (P = <.001) for women after seeing the video interventions vs 0.0 and -0.06 (P = .75) after seeing the print interventions. At the study end, 33% of men and 49% of women wanted screening, and 11% and 20%, respectively, were unsure.Conclusions: Our novel, persuasive video interventions significantly changed the screening intentions of substantial proportions of viewers. Our approach needs further testing but may provide a model for helping patients to consider and accept evidence-based, counterintuitive recommendations. [ABSTRACT FROM AUTHOR]

Child birth order (CBO) in the family has received little attention in the field of prevention science. CBO is relevant to early interventionists from a public health perspective, as the most widely disseminated home-visiting program has traditionally targeted mothers and their first-born children. The current paper revisits a previous publication by Shaw et al. (2009) on the effectiveness of the Family Check-Up (FCU) to evaluate CBO (firstborn vs. middle vs. youngest) as a moderator of treatment effects of the FCU in relation to improvements in parenting, maternal depressive symptoms, and child outcomes from ages 2 to 4 in a sample of low-income, ethnically diverse families (N = 709) with multiple children. Results suggest that the FCU elicited improvements in observed parenting from ages 2 to 3 primarily for target children who were the youngest or middle children, but not for firstborns. Findings are discussed in the context of implications for prevention science research, dissemination, and public policy. [ABSTRACT FROM AUTHOR]

Background: While vaccines have reduced the incidence of vaccine-preventable diseases, vaccine hesitancy threatens the re-emergence of childhood infectious diseases. Purpose: This randomized controlled study evaluated an online vaccine education program to advance vaccine acceptance among middle-school students. Methodology: Study participants were randomly assigned to an intervention group who viewed the VEP videos or to a comparison group who viewed a science-based video unrelated to vaccines. Results: Knowledge scores improved in both groups and more favorable shifts in vaccine-related beliefs and attitudes occurred in the intervention than in the comparison group. Conclusions: This program can be feasibly delivered via an online platform to middle school students, resulting in shifts in vaccine-related knowledge, beliefs and attitudes. Implications: Delivering evidence-based content to instruct about vaccine effectiveness and safety is an area in which school nurses have demonstrated an important role as a resource for patient education to promote vaccine advocacy. [ABSTRACT FROM AUTHOR]

Introduction: Little is known on how to communicate messages on tobacco constituents to tobacco users. This study manipulated three elements of a message in the context of a theory-based communication campaign about tobacco constituents: (1) latency of response efficacy (how soon expected health benefits would accrue), (2) self-efficacy (confidence about quitting), and (3) interrogative cue ("Ready to be tobacco-free?").Methods: Smokers (N = 1669, 55.4% women) were recruited via an online platform, and were randomized to a 3 (Latency of response efficacy) × 2 (Self-efficacy) × 2 (Interrogative cue) factorial design. The dependent variables were believability, credibility, perceived effectiveness of the communication message, and action expectancies (likelihood of seeking additional information and help with quitting).Results: Latency of response efficacy influenced believability, perceived effectiveness, credibility, and action expectancies. In each case, scores were higher when specific health benefits were said to accrue within 1 month, as compared to general health benefits occurring in a few hours. The interrogative cue had a marginal positive effect on perceived effectiveness. The self-efficacy manipulation had no reliable effects, and there were no significant interactions among conditions.Conclusions: Smokers appear less persuaded by a communication message on constituents where general health benefits accrue immediately (within a few hours) than specific benefits over a longer timeframe (1 month). Additionally, smokers appeared to be more persuaded by messages with an interrogative cue. Such findings may help design more effective communication campaigns on tobacco constituents to smokers.Implications: This paper describes, for the first time, how components of tobacco constituent messages are perceived. We now know that smokers appear to be less persuaded by communication messages where general health benefits accrue immediately (within a few hours) than specific benefits over a longer timeframe (1 month). Additionally, including an interrogative cue ("Ready to be tobacco free?") may make messages more effective, whereas the self-efficacy manipulation designed to increase confidence about quitting had no effect. While messages were universally impactful across smoker subpopulations, everyday smokers and smokers with less trust in the government may be less receptive to communication campaigns. [ABSTRACT FROM AUTHOR]

6–11-year-old children provide a critical window for physical activity (PA) interventions. The Virtual Fitness Buddy ecosystem is a precision health PA intervention for children integrating mixed reality technology to connect people and devices. A cluster randomized, controlled trial was conducted across 19 afterschool sites over two 6-month cohorts to test its efficacy in increasing PA and decreasing sedentary behavior. In the treatment group, a custom virtual dog via a mixed reality kiosk helped children set PA goals while sharing progress with parents to receive feedback and support. Children in the control group set PA goals using a computer without support from the virtual dog or parents. 303 children had 8+ hours of PA data on at least one day of each of the 3 intervention time intervals. Conversion of sedentary time was primarily to light-intensity PA and was strongest for children with low baseline moderate-to-vigorous PA than children above 45 min of baseline moderate-to-vigorous PA. Findings suggest that the VFB ecosystem can promote sustainable PA in children and may be rapidly diffused for widespread public health impact. [ABSTRACT FROM AUTHOR]

Background: Diabetes impacts greater than 37 million people in the United States. Adults over 45 years, racial-ethnic minorities, and those who are overweight or obese are at increased risk for type 2 diabetes mellitus (T2DM). Digital health games offer one innovative opportunity to engage, educate, and motivate adults at risk for T2DM about healthy lifestyle changes. Objective: Describe the adaptation of an educational exergame for adults over 50 and examine feasibility, acceptability, and implementation within a health education intervention in African American adults at risk for T2DM. Method: Mixed methods were used: exploratory adaptation phase involving expert interviews and constituent focus groups; a randomized two-group (nutrition workshop alone vs workshop plus game) pilot exploring adherence and preliminary outcomes (i.e., eating habits, physical activity level, body mass index); and a post-gameplay explanatory component examining acceptability and feasibility. Results: Exploratory phase findings identified areas for game adaptation, such as modifying graphics and adjusting movement to user preferences and abilities. The pilot sample included 24 African American women with T2DM risk factors (Mean age = 63.1). Preliminary outcomes suggest pre-post intervention changes in the direction of improvement for both groups; however, there were no statistically significant differences between groups. Intervention adherence was slightly higher for the game-plus workshop group. Acceptability and feasibility feedback of the game was generally positive. Conclusion: Constituent and expert input helped inform game adaptation. Preliminary outcomes and acceptability/feasibility feedback of game implementation within a health education intervention showed promise in engaging adults over 50 with T2DM risk factors about topics of healthy eating and physical activity. Continued research is suggested to develop/adapt health games to promote healthy lifestyle change in diverse older adults (e.g., adults over 65; racial-ethnic minority groups;) and to conduct large-scale studies to evaluate the impact of health games in diverse groups and settings. [ABSTRACT FROM AUTHOR]

Background: Emergency department (ED) visits among older adults are common near the end of life. Palliative care has been shown to reduce ED visits and to increase quality of life among patients, but recruitment into these programs is often challenging. This descriptive analysis explores the barriers to enrolling seriously ill patients scheduled for discharge from the ED into palliative care research. Methods: This descriptive sub-study aims to assess the reasons why patients with advanced illness scheduled for discharge home from 11 EDs across the United States decline to participate in Emergency Medicine Palliative Care Access (EMPallA), a Phase IV randomized controlled trial (RCT) comparing two modes of palliative care delivery. Our aim was to understand why patients decline to enroll to improve future recruitment rates and expand care for patients discharged home from the ED. Research coordinators documented reasons that patients declined to enroll in the larger EMPallA trial; reasons for refusing participation were independently analyzed by two researchers to identify overarching themes. Results: Enrollment rate across all sites was 45%; of the 504 eligible patients who declined participation, 47% (n = 237) declined for reasons related to illness severity. 28% of refusals (n = 143) were related to the mode of palliative care delivery, while 24% (n = 123) were due to misconceptions or stigma related to palliative care. Less commonly, patients refused due to general research barriers (16.5%), family/caregiver barriers (11.7%), and physician-related barriers (< 1%). Conclusions: Patients with advanced illnesses presenting to the ED often refuse to participate in palliative care research due to the severity of their illness, the mode of care delivery, and misconceptions about palliative care. In contrast with other studies, our study found minimal physician gatekeeping, which may be the result of both changing attitudes toward palliative care and the nature of the ED setting. Robust training programs are crucial to overcome these misconceptions and to educate patients and providers about the role of palliative care. Future palliative care programs and study designs should recognize the burden this vulnerable population endures and consider alternative modes of care delivery in an effort to increase participation and enrollment. Clinical trials registration: NCT03325985, October 30, 2017. [ABSTRACT FROM AUTHOR]

Background: Neurofeedback is considered a promising intervention for the treatment of attention‐deficit hyperactivity disorder (ADHD). NEWROFEED is a prospective, multicentre, randomized (3:2), reference drug‐controlled trial in children with ADHD aged between 7 and 13 years. The main objective of NEWROFEED was to demonstrate the noninferiority of personalized at‐home neurofeedback (NF) training versus methylphenidate in the treatment of children with ADHD. Methods: The NF group (n = 111) underwent eight visits and two treatment phases of 16 to 20 at‐home sessions with down‐training of the theta/beta ratio (TBR) for children with high TBR and enhancing the sensorimotor rhythm (SMR) for the others. The control group (n = 67) received optimally titrated long‐acting methylphenidate. The primary endpoint was the change between baseline and endpoint in the Clinician ADHD‐RS‐IV total score in the per‐protocol population (90 NF/59 controls). Trial registration: US National Institute of Health, ClinicalTrials.gov #NCT02778360. Results: Our study failed to demonstrate noninferiority of NF versus methylphenidate (mean between‐group difference 8.09 90% CI [8.09; 10.56]). However, both treatment groups showed significant pre–post improvements in core ADHD symptoms and in a broader range of problems. Reduction in the Clinician ADHD‐RS‐IV total score between baseline and final visit (D90) was 26.7% (SMD = 0.89) in the NF and 46.9% (SMD = 2.03) in the control group. NF effects increased whereas those of methylphenidate were stable between intermediate and final visit. Conclusions: Based on clinicians' reports, the effects of at‐home NF were inferior to those of methylphenidate as a stand‐alone treatment. [ABSTRACT FROM AUTHOR]

Background Influenza outbreaks in nursing homes pose a threat to frail residents and occur even in vaccinated populations. We conducted a pragmatic cluster-randomized trial comparing adjuvanted trivalent influenza vaccine (aTIV) versus trivalent influenza vaccine (TIV). We report an exploratory analysis to compare the effect of aTIV versus TIV on facility-reported influenza outbreaks. Methods We evaluated the impact of the intent-to-treat vaccine assignment on outbreaks reported from November 2016 to March 2017. We collected data according to standard CDC definitions for both suspected outbreaks and those with a laboratory-confirmed case and adjusted for facility-level vaccination rates and resident characteristics in nursing homes. Results Of 823 randomized nursing homes, 777 (aTIV, n = 387; TIV, n = 390) reported information on influenza outbreaks. Treatment groups had similar characteristics at baseline except for race/ethnicity: homes assigned to TIV had a higher percentage of African-American residents (18.0% vs 13.7%). There were 133 versus 162 facility-reported suspected influenza outbreaks in aTIV versus TIV facilities, respectively; of these, 115 versus 140 were laboratory confirmed. The aTIV group experienced a 17% reduction in suspected (rate ratio,.83; 95% confidence interval,.65–1.05) and laboratory-confirmed (.83;.63–1.06) influenza outbreaks. Covariate adjustment increased the estimated reduction for suspected outbreaks to 21% (.79;.61–.99) and 22% for laboratory-confirmed outbreaks (.78;.60–1.02). Conclusions In an exploratory analysis of a cluster-randomized trial we observed 17–21% fewer outbreaks with aTIV than TIV. Clinical Trials Registration. (NCT02882100). [ABSTRACT FROM AUTHOR]

This paper reports on the evaluation of a culturally grounded prevention intervention targeting substance use among urban middle-school students. The curriculum consists of 10 lessons promoting antidrug norms and teaching resistance and other social skills, reinforced by booster activities and a media campaign. Three versions were delivered: Mexican American, combined African American and European American, and Multicultural. Thirty-five middle schools were randomly assigned to 1 of the 3 versions or the control. Students completed baseline and follow-up questionnaires over a 2-year period (total 6,035 respondents). Analyses utilizing a generalized estimating equations approach assessed the overall effectiveness of cultural grounding and the cultural matching hypothesis. Support was found for the intervention's overall effectiveness, with statistically significant effects on gateway drug use as well as norms, attitudes, and resistance strategies but with little support for the cultural matching hypothesis. Specific contrasts found the Mexican American and Multicultural versions impacted the most outcomes. [ABSTRACT FROM AUTHOR]

Few comprehensive primary prevention approaches for youth have been evaluated for effects on multiple types of violence. Dating Matters®: Strategies to Promote Healthy Teen Relationships (Dating Matters) is a comprehensive teen dating violence (TDV) prevention model designed by the Centers for Disease Control and Prevention and evaluated using a longitudinal stratified cluster-randomized controlled trial to determine effectiveness for preventing TDV and promoting healthy relationship behaviors among middle school students. In this study, we examine the prevention effects on secondary outcomes, including victimization and perpetration of physical violence, bullying, and cyberbullying. This study examined the effectiveness of Dating Matters compared to a standard-of-care TDV prevention program in 46 middle schools in four high-risk urban communities across the USA. The analytic sample (N = 3301; 53% female; 50% Black, non-Hispanic; and 31% Hispanic) consisted of 6th-8th grade students who had an opportunity for exposure to Dating Matters in all three grades or the standard-of-care in 8th grade only. Results demonstrated that both male and female students attending schools implementing Dating Matters reported 11% less bullying perpetration and 11% less physical violence perpetration than students in comparison schools. Female Dating Matters students reported 9% less cyberbullying victimization and 10% less cyberbullying perpetration relative to the standard-of-care. When compared to an existing evidence-based intervention for TDV, Dating Matters demonstrated protective effects on physical violence, bullying, and cyberbullying for most groups of students. The Dating Matters comprehensive prevention model holds promise for reducing multiple forms of violence among middle school-aged youth. ClinicalTrials.gov Identifier: NCT01672541. [ABSTRACT FROM AUTHOR]

Managing multicenter clinical trials (MCTs) is demanding and complex. The Randomized controlled Evaluation of high-volume hemofiltration in adult burn patients with Septic shoCk and acUte kidnEy injury (RESCUE) trial was a prospective, MCT involving the impact of high-volume hemofiltration continuous renal replacement therapy on patients experiencing acute kidney injury and septic shock. Ten clinical burn centers from across the United States were recruited to enroll a target sample size of 120 subjects. This manuscripts reviews some of the obstacles and knowledge gained while coordinating the RESCUE trial. The first subject was enrolled in February 2012, 22 months after initial IRB approval and 29 months from the time the grant was awarded. The RESCUE team consisted of personnel at each site, including the lead site, a data coordination center, data safety monitoring board, steering committees, and the sponsor. Seven clinical sites had enrolled 37 subjects when enrollment stopped in February 2016. Obstacles included changes in institutional review boards, multiple layers of review, staffing changes, creation and amendment of study documents and procedures, and finalization of contracts. Successful completion of a MCT requires a highly functional research team with sufficient patient population, expertise, and research infrastructure. Additionally, realistic timelines must be established with strategies to overcome challenges. Inevitable obstacles should be discussed in the pretrial phase and continuous correspondence must be maintained with all relevant research parties throughout all phases of study. [ABSTRACT FROM AUTHOR]

Background: Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers. Objectives and Hypotheses: Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients. Methods: Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization. Setting: Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020. Participants: Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer. Interventions: In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team. Main Outcomes and Measures: Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used. Ethics and Dissemination: This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018). [ABSTRACT FROM AUTHOR]

Background Transgender women are disproportionately incarcerated in the US relative to the general population. A dearth of research has explored the factors that predict incarceration among transgender women or the longitudinal impact of incarceration on the health of this population. Methods Between 2012 and 2015, 221 transgender women ages 16–29 from Boston, MA and Chicago, IL were prospectively assessed at baseline, 4, 8 and 12 months. Mixed effects models were used to identify risk factors for incarceration and examine whether incarceration predicts somatic, anxiety and depressive symptoms, illicit drug use, and binge drinking over time, controlling for baseline psychiatric and substance use disorders. Results Overall, 38% experienced incarceration, before (33%) and during (18%) the study period. Significant independent predictors of recent incarceration included sex work, recent homelessness, school dropout and number of times incarcerated prior to enrollment while recent incarceration significantly predicted somatic symptoms and illicit drug use over time. Conclusions Incarceration burden is high in young transgender women. Both structural and individual risk factors predict incarceration and poor health, suggesting the need for multilevel interventions to prevent incarceration and support young transgender women during incarceration and upon release. [ABSTRACT FROM AUTHOR]

Background: Physician burnout is associated with deleterious effects for physicians and their patients and might be exacerbated by practice transformation.Objective: Assess the effect of the Comprehensive Primary Care (CPC) initiative on primary care physician experience.Design: Prospective cohort study conducted with about 500 CPC and 900 matched comparison practices. Mail surveys of primary care physicians, selected using cross-sectional stratified random selection 11 months into CPC, and a longitudinal design with sample replacement 44 months into CPC.Participants: Primary care physicians in study practices.Intervention: A multipayer primary care transformation initiative (October 2012-December 2016) that required care delivery changes and provided enhanced payment, data feedback, and learning support.Main Measures: Burnout, control over work, job satisfaction, likelihood of leaving current practice within 2 years.Key Results: More than 1000 physicians responded (over 630 of these in CPC practices) in each round (response rates 70-81%, depending on round and research group). Physician experience outcomes were similar for physicians in CPC and comparison practices. About one third of physician respondents in CPC and comparison practices reported high levels of burnout in each round (32 and 29% in 2013 [P = 0.59], and 34 and 36% in 2016 [P = 0.63]). Physicians in CPC and comparison practices reported some to moderate control over work, with an average score from 0.50 to 0.55 out of 1 in 2013 and 2016 (CPC-comparison differences of - 0.04 in 2013 [95% CI - 0.08-0.00, P = 0.07], and - 0.03 in 2016 [95% CI - 0.03-0.02, P = 0.19]). In 2016, roughly three quarters of CPC and comparison physicians were satisfied with their current job (77 and 74%, P = 0.77) and about 15% planned to leave their practice within 2 years (14 and 15%, P = 0.17).Conclusions: Despite requiring substantial practice transformation, CPC did not affect physician experience. Research should track effects of other transformation initiatives on physicians and test new ways to address burnout.Trial Registration: ClinicalTrials.gov number, NCT02320591. [ABSTRACT FROM AUTHOR]

Background: Decision makers are increasingly tasked with reducing health care costs, but the public may be mistrustful of these efforts. Public deliberation helps gather input on these types of issues by convening a group of diverse individuals to learn about and discuss values-based dilemmas.Objective: To explore public perceptions of health care costs and how they intersect with medical mistrust.Design and Participants: This mixed-methods study analyzed data from a randomized controlled trial including four public deliberation groups (n = 96) and a control group (n = 348) comprising English-speaking adults aged 18 years and older. Data were collected in 2012 in four U.S. regions.Approach: We used data from four survey items to compare attitude shifts about costs among participants in deliberation groups to participants in the control group. We qualitatively analyzed deliberation transcripts to identify themes related to attitude shifts and to provide context for quantitative results about attitude shifts.Key Results: Deliberation participants were significantly more likely than control group participants to agree that doctors and patients should consider cost when making treatment decisions (β = 0.59; p < 0.01) and that people should consider the effect on group premiums when making treatment decisions (β = 0.48; p < 0.01). Qualitatively, participants mistrusted the health care system's profit motives (e.g., that systems prioritize making money over patient needs); however, after grappling with patient/doctor autonomy and learning about and examining their own views related to costs during the process of deliberation, they largely concluded that payers have the right to set some boundaries to curb costs.Conclusions: Individuals who are informed about costs may be receptive to boundaries that reduce societal health care costs, despite their mistrust of the health care system's profit motives, especially if decision makers communicate their rationale in a transparent manner. Future work should aim to develop transparent policies and practices that earn public trust. [ABSTRACT FROM AUTHOR]

Communication campaigns often include components that have been designed for a specific population, a strategy referred to as targeting. Targeted narratives are story-based components of a campaign that feature a character or situation relevant to the intended audience. Though commonplace, few studies have explicated the underlying mechanisms by which targeted narratives exert influence. In a message evaluation study, 316 women aged 40–75 (Mage = 51.19,SD = 8.11) were exposed to one of two targeted narratives and asked to complete measures of model admiration, narrative memorability, and intentions to receive a mammography. Targeting was based upon affiliation with the Mormon church. The results revealed that the relationship between the targeted narratives and screening intentions was especially strong for women from the target population who admired the depicted models and found the stories memorable. [ABSTRACT FROM PUBLISHER]

Background: Involuntary exposure to secondhand smoke (SHSe) is an important cause of morbidity in children who present to the pediatric emergency department (PED) and urgent care (UC). SHSe interventions delivered in the PED and UC would benefit both the smoker and child, but there have been no large trials testing the efficacy of such interventions. The Healthy Families program is the first randomized controlled trial to test whether a screening, brief intervention, and referral to treatment (SBIRT) intervention delivered in the PED and UC will be effective in decreasing SHSe in children and increasing cessation in smokers.Methods/design: This trial uses a randomized, two-group design in which caregiver-smokers of children 0-17 years old are recruited from the PED and UC. Eligible caregiver-smokers are randomized to either the: 1) SBIRT Condition with face-to-face, tailored counseling that focuses on the child's illness, the importance of reducing child SHSe, caregiver smoking cessation, and the option to receive nicotine replacement therapy; or 2) Healthy Habits Control Condition which includes face-to-face, tailored attention control "5-2-1-0" counseling that focuses on improving the child's health. Dyadic assessments are conducted in-person at baseline, and via email, phone, or in-person at 6-weeks and 6-months. The primary outcomes are biochemically-verified, 7-day point prevalence and prolonged smoking abstinence. Secondary outcomes are cigarettes smoked per week, 24 h quit attempts, and biochemically validated child SHSe at each time point. The costs of this intervention will also be analyzed.Discussion: This study will test an innovative, multilevel intervention designed to reduce child SHSe and increase smoking cessation in caregivers. If effective and routinely used, this SBIRT model could reach at least one million smokers a year in the U.S., resulting in significant reductions in caregivers' tobacco use, SHSe-related pediatric illness, and healthcare costs in this population of children.Trial Registration: ClinicalTrials.gov Identifier: NCT02531594. Date of registration: August 4, 2015. [ABSTRACT FROM AUTHOR]

Objective: To examine the efficacy of different methods (ie, in-class policy reading; in-class policy reading and discussion; no reading or discussion) to deliver campus sexual misconduct policy information to students on 7 campuses. Participants: A total of 1,195 participants at 7 colleges and universities participated in the study from August to October 2014. Participants were randomly assigned at the class level and completed pretest and posttest surveys assessing knowledge of campus policy and resources and confidence to seek help for sexual assault. Results: Students exposed to a larger dosage of material (in-class policy reading plus discussion) showed greater positive changes in attitudes and knowledge than students who did not receive information or were only read the policy. However, on some indices, students who were only read the policy showed positive outcomes compared with students receiving no intervention. Conclusion: Colleges and universities must use engaging methods to disseminate campus sexual misconduct policies to students. [ABSTRACT FROM AUTHOR]

Background Systemic Lupus Erythematosus (lupus) is a chronic autoimmune disease that can impact any organ system and result in life-threatening complications. African-Americans are at increased risk for morbidity and mortality from lupus. Self-management programs have demonstrated significant improvements in health distress, self-reported global health, and activity limitation among people with lupus. Despite benefits, arthritis self-management education has reached only a limited number of people. Self-selection of program could improve such trends. The aim of the current study is to test a novel intervention to improve quality of life, decrease indicators of depression, and reduce perceived and biological indicators of stress in African-American lupus patients in South Carolina. Methods/design: In a three armed randomized, wait list controlled trial, we will evaluate the effectiveness of a patient-centered 'a-la-carte' approach that offers subjects a variety of modes of interaction from which they can choose as many or few as they wish, compared to a 'set menu' approach and usual care. This unique 'a-la-carte' self-management program will be offered to 50 African-American lupus patients participating in a longitudinal observational web-based SLE Database at the Medical University of South Carolina. Each individualized intervention plan will include 1-4 options, including a mail-delivered arthritis kit, addition and access to an online message board, participation in a support group, and enrollment in a local self-management program. A 'set menu' control group of 50 lupus patients will be offered a standardized chronic disease self-management program only, and a control group of 50 lupus patients will receive usual care. Outcomes will include changes in (a) health behaviors, (b) health status, (c) health care utilization, and (d) biological markers (urinary catecholamines). Discussion: Such a culturally sensitive educational intervention which includes self-selection of program components has the potential to improve disparate trends in quality of life, disease activity, depression, and stress among African-American lupus patients, as better outcomes have been documented when participants are able to choose/dictate the content and/or pace of the respective treatment/intervention program. Since there is currently no "gold standard" self-management program specifically for lupus, this project may have a considerable impact on future research and policy decisions. [ABSTRACT FROM AUTHOR]

Introduction: Financial incentives are effective for smoking cessation during pregnancy. Public opinion is important for successful dissemination of this approach from research into clinical practice. We developed a brief information-based intervention to improve public acceptability.Methods: We recruited 166 adult participants (54.2% females [6.7% pregnant], 25.3% smokers, mean age 32.4 years [SD, 9.9]) currently living the United States from Amazon Mechanical Turk. They were randomized to either intervention (N = 84) or control (N = 82). The control group read educational materials on car safety for pregnant women and young children. The intervention group read educational materials on the rationale behind using financial incentives for smoking cessation during pregnancy. Key outcomes were 11 opinion items regarding whether using financial incentives to help pregnant smokers to quit is a good idea; its effectiveness, fairness, cost, health benefits, and saved healthcare cost; and pregnant women's responsibility and difficulty of quitting smoking.Results: Intervention and control groups had similar pretest opinion on using financial incentives for smoking cessation during pregnancy. All 11 mean opinion scores significantly increased in the intervention group, but remained stable in the control group. After the intervention, 27.7% more of participants (from 62.6% to 90.3%; P value < .001) in the intervention group and only 4.8% more (from 64.6% to 69.4%; P value = .557) in the control group agreed that "Paying pregnant women who smoke to quit smoking is a good idea" (interaction P value = .015).Conclusions: Our low-cost information-based intervention has the potential to improve public acceptability of this efficacious approach to promoting smoking cessation during pregnancy.Implications: In this sample of educated young adults, our low-cost information-based intervention substantially improved their acceptability of using financial incentives for smoking cessation during pregnancy. Our intervention can be used to gain public support before implementing this approach as a policy in the general population. One potential concern that needs to be further addressed by future intervention is unfairness of this smoking cessation approach to pregnant nonsmokers. [ABSTRACT FROM AUTHOR]

Objective: To compare judgements of nutrition and judgement accuracy when evaluating cereals with the current US Food and Drug Administration (FDA) nutrition facts panel (NFP) and two new proposed NFP based on FDA guidelines.Design: A between-subjects design randomly assigned participants to three NFP conditions (current NFP label and two modified NFP based on FDA proposals). Participants viewed breakfast cereals, and rated each on nutritional quality and on the likelihood of purchasing and consuming it. Participants provided demographic information and responses to questionnaires assessing nutrition/obesity knowledge, concern for healthy eating and nutrient importance.Setting: USA.Subjects: Two hundred and thirteen adults who completed an online survey (66·2 % female, mean age 37·31 (sd 12·56) years).Results: Judged nutrition quality of cereals was positively correlated with protein, fibre and potassium and negatively correlated with sugars and sodium. This pattern appeared when using the current NFP or the modified versions. Highlighted nutrients in modified NFP formats did not affect their perceived importance. Accuracy of the nutrition quality judgements was measured in relationship to an objectively defined nutrition score, NuVal®. Nutrition judgement accuracy was highest under the current NFP (Spearman's ρ=0·76 for the current NFP; 0·64 and 0·72 for the other formats). Regression analysis showed that nutrition judgement accuracy increased significantly (adjusted R 2=0·13) with obesity knowledge (β=0·27), age (β=0·15) and current NFP (β=0·13).Conclusions: The current NFP is equally or more effective in conveying nutritional information compared with NFP formats based on the FDA proposal. [ABSTRACT FROM AUTHOR]

Background Reducing the nicotine content in cigarettes could improve public health by reducing smoking and toxicant exposure, but may also have unintended consequences on alcohol use. The primary objective of this study was to examine the effect of reducing the nicotine content in cigarettes on alcohol outcomes. The secondary aim was to examine whether the effects of these cigarettes on alcohol outcomes were mediated by changes in nicotine exposure, smoking behavior, or withdrawal. Methods Between June 2013 and July 2014, we conducted a 7-arm, double-blind, randomized clinical trial at 10 U. S.-based sites. Daily smokers not currently interested in quitting ( n = 839) were assigned to equally sized groups to smoke for 6 weeks cigarettes containing either normal nicotine content ( NNC; 15.8 mg/g, 9 mg tar), moderate nicotine content (5.2 mg/g nicotine, 9 mg tar), or very low nicotine content ( VLNC; 0.4 to 2.4 mg/g, 9 to 13 mg tar). This investigation focused on a subsample of current drinkers ( n = 403). Each reduced nicotine content cigarette condition was compared to the NNC control condition with respect to trajectories over the 6-week period of average daily alcohol use and occurrence of binge drinking. Moderating variables were considered. Mediation analyses tested potential explanatory processes including changes in nicotine exposure, cigarettes per day, and withdrawal. Results Over time, reduced nicotine exposure and smoking rate mediated effects of VLNC cigarette use on reduced alcohol use. There was no evidence of compensatory drinking in response to nicotine reduction or nicotine withdrawal, even among subgroups expected to be at greater risk (e.g., relatively heavier drinkers, highly nicotine-dependent individuals). Conclusions The findings suggest that compensatory drinking is unlikely to occur in response to switching to VLNC cigarettes. In contrast, reducing the nicotine content of cigarettes may reduce alcohol use (clinicalTrials.gov number, NCT01681875). [ABSTRACT FROM AUTHOR]

Introduction: As part of its mission, the US Food and Drug Administration (FDA) communicates with the public regularly about the benefits and risks of prescription and over-the-counter (OTC) drugs. Effectively communicating risk, however, is a significant public health challenge.Objective: To better understand how different populations understand information communicated by the FDA about drug safety, we conducted a randomized experiment to examine comprehension and other measures of effectiveness of drug safety messages that occurred in a post-market surveillance phase.Methods: We used an Internet panel survey of 1244 consumers, of whom 58% used prescription drugs in the past year. Half of the sample panel was randomized to read a previous FDA Drug Safety Communication (DSC) with the drug name changed, and the other half was randomized to read a revised version of the same DSC. We examined how making certain modifications to the way drug risk information is communicated has an impact on comprehension and behavioral intentions, including the user's likelihood of discontinuing the drug. We also studied how comprehension varied by respondent characteristics, health literacy skills, risk perceptions, and trust in the message.Results: Based on a five-item comprehension index, the revised version of the message was associated with significantly greater comprehension of the information relative to the standard version (63 vs 52% correct, p < 0.001). Significantly more respondents found the revised version to be clear (82 vs 73%, p < 0.000), while fewer in that group reported learning something new (78% vs 84%, p = 0.015). No significant differences emerged between the two groups in terms of the message being informative, convincing, or helpful. We found no significant differences between the two groups in terms of behavioral intentions, risk perception, and trust.Conclusions: We found that making plain language changes to the DSC significantly increased consumers' level of comprehension of its content, providing support for ongoing use and further exploration of these strategies in pharmacovigilance communication research. The study findings have important implications for future drug safety and other communication messages related to prescription drugs. [ABSTRACT FROM AUTHOR]

Background: In clinical trials of medications to treat attention-deficit/hyperactivity disorder (ADHD) in children, effects on functional impairment have been less well-studied than changes in ADHD symptoms.Objective: Data regarding functional impairment were analyzed from a multicenter, double-blind, placebo-controlled study of guanfacine extended release (GXR) in children with ADHD, using the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P). The correspondence of changes in WFIRS-P scores with symptomatic and global response to GXR treatment was also examined, with treatment response defined by scores on both the ADHD Rating Scale IV (ADHD-RS-IV) and the Clinical Global Impressions-Improvement Scale (CGI-I).Methods: In this 8-week, double-blind, placebo-controlled, dose optimization study at 47 sites across the USA and Canada, children aged 6-12 years with a diagnosis of ADHD [Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria, and an ADHD-RS-IV score ≥28 and CGI-Severity of Illness Scale score ≥4 at baseline], were randomized 1:1:1 into three groups: GXR AM [GXR (1-4 mg/day) in the morning, placebo in the evening], GXR PM [placebo in the morning, GXR (1-4 mg/day) in the evening], or twice-daily placebo. Parents rated their children on the WFIRS-P at screening, baseline, the end of dose optimization, and at the final on-treatment assessment.Results: The efficacy population was composed of 333 subjects (GXR AM: n = 107; GXR PM: n = 114; placebo: n = 112). At the final on-treatment assessment, there were significant improvements from baseline in the placebo-adjusted difference in least-squares (LS) mean (95 % confidence interval) WFIRS-P Total scores for both GXR treatment groups combined [GXR all-active: -0.16 (-0.25, -0.07), effect size (ES) = 0.448, P <0.001] and separately [GXR AM: -0.15 (-0.26, -0.05), ES = 0.417, P = 0.004; GXR PM: -0.18 (-0.28, -0.07), ES = 0.478, P = 0.001]. Significant improvements in WFIRS-P domain scores for Family, Learning and School (including Academic Performance and Behavior in School), Social, and Risky Behavior were found for both GXR cohorts compared with placebo. However, the Life Skills and Self-Concept domain scores of the WFIRS-P did not improve with GXR treatment. Post hoc stratification by responder status revealed that significant (P <0.001) improvements in WFIRS-P Total and all domain scores were associated with symptomatic treatment response in the GXR all-active group.Conclusions: GXR treatment in children with ADHD was associated with reductions in WFIRS-P functional impairment scores compared with placebo, regardless of time of GXR administration. Changes in WFIRS-P scores were congruent with clinical response, as determined by both ADHD symptom reduction and CGI-I scores. CLINICALTRIALS.Gov Identifier: NCT00997984. [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]

Objective: To investigate the effectiveness of an online, interactive intervention, referred to as the Green Eating (GE) Project, to motivate university students to adopt GE behaviours.Design: The study was quasi-experimental and integrated into courses for credit/extra credit. Courses were randomly stratified into experimental or non-treatment control. The 5-week intervention consisted of four modules based on different GE topics. Participants completed the GE survey at baseline (experimental, n 241; control, n 367) and post (experimental, n 187; control, n 304). The GE survey has been previously validated and consists of Transtheoretical Model constructs including stage of change (SOC), decisional balance (DB: Pros and Cons) and self-efficacy (SE: School and Home) as well as behaviours for GE. Modules contained basic information regarding each topic and knowledge items to assess content learning.Setting: The GE Project took place at a public university in the north-eastern USA.Subjects: Participants were full-time students between the ages of 18 and 24 years.Results: The GE Project was effective in significantly increasing GE behaviours, DB Pros, SE School and knowledge in experimental compared with control, but did not reduce DB Cons or increase SE Home. Experimental participants were also more likely to be in later SOC for GE at post testing.Conclusions: The GE Project was effective in increasing GE behaviours in university students. Motivating consumers towards adopting GE could assist in potentially mitigating negative consequences of the food system on the environment. Future research could tailor the intervention to participant SOC to further increase the effects or design the modules for other participants. [ABSTRACT FROM AUTHOR]

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The article presents research which analyzed the cost-effectiveness of early and delayed repair for anterior cruciate ligament injuries. Topics covered include the importance of surgical reconstruction to treat tear in anterior cruciate ligament (ACL) as well as use of Markov decision model to assess the repair. Also mentioned is the application of the Multicenter Orthopaedic Outcomes Network (MOON) database in the study.

Aims Investigators of the COMBINE ( Combining Medications and Behavioral Interventions for Alcoholism) study examined whether combining medications with a behavioral intervention would improve outcomes over monotherapies. Unexpectedly, the combination did not offer any advantage over either treatment alone. This study aimed to explain the lack of incremental benefit offered by the combination over either monotherapy by assessing the role of cravings as a treatment mediator and moderator. Design Secondary mediation and moderation analyses of COMBINE study data. Setting Eleven United States academic sites. Participants A total of 863 patients randomized to one of four treatment groups: naltrexone (100 mg/day; n = 209), the combined behavioral intervention ( CBI, n = 236), naltrexone and CBI combined ( n = 213) and placebo naltrexone ( n = 205). Measurements Percentage of days abstinent ( PDA) measured between 13 and 16 weeks post-baseline. Cravings, the potential mediator/moderator, were measured at baseline, weeks 4 and 12 using the Obsessive- Compulsive Drinking Scale. Findings Compared with placebo, naltrexone, CBI and the combination all increased PDA by an additional 6-10 percentage points for those with high cravings ( P < 0.05 for all three treatment groups). None had significant effects on PDA for those with low cravings. The effects of all three treatments were mediated at least partially by cravings; craving reduction explained 48-53% of treatment effects ( P < 0.05 for all three treatment groups). Furthermore, naltrexone appeared to reduce cravings at 4 weeks, while CBI did not reduce cravings until 12 weeks. Conclusions The Combining Medications and Behavioral Interventions for Alcoholism ( COMBINE) naltrexone + CBI combination may not be more beneficial than either monotherapy because craving reduction is a common mechanism of both. [ABSTRACT FROM AUTHOR]

Objectives To determine optimal repositioning frequency of nursing home ( NH) residents at risk for pressure ulcers (PrUs) when cared for on high-density foam mattresses. Design Multisite, randomized, clinical trial, known as Turning for Ulcer ReductioN ( TURN Study). Settings NHs in the United States (n = 20) and Canada (n = 7) using high-density foam mattresses. Participants Consenting residents (N = 942) aged 65 and older without PrUs at moderate (scores 13-14) or high (scores 10-12) risk of PrUs according to the Braden Scale. Intervention Participants were randomly allocated using risk stratification (moderate vs high) to a repositioning schedule (2, 3, or 4 hour) for 3 weeks. Blinded assessors assessed skin weekly. Measurements PrU incidence (coccyx or sacrum, trochanter, heels). Results Participants were mostly female (77.6%) and Caucasian (80.5%) and had a mean age of 85.1 ± 7.7. The most common diagnoses were cardiovascular (76.9%) and dementia (72.5%). Nineteen (2.0%) participants developed superficial PrUs. There was no significant difference (Wilcoxon test for ordered categories) in PrU incidence ( P = .68) according to repositioning group (2 hour, 8/321, 2.5%; 3 hour, 2/326, 0.6%; 4 hour, 9/295, 3.1%), nor was there a statistically significant difference in the incidence of PrU between the high and moderate-risk groups ( P = .79). Also, PrU incidence was not statistically significantly different between high-risk participants based on repositioning schedule (6/325, 1.8%, P = .90) or between moderate-risk participants based on repositioning schedule (13/617, 2.1%, P = .68). Conclusion There was no difference in PrU incidence over 3 weeks of observation between those turned at 2-, 3-, or 4-hour intervals in this population of residents using high-density foam mattresses at moderate and high risk of developing PrUs when they were repositioned consistently and skin was monitored. This finding has major implications for use of nursing staff and cost of NH care. [ABSTRACT FROM AUTHOR]

Aim To report the psychometric testing of the Household Risk Perception and Self-Efficacy in Environmental Risk Reduction instruments using principal components analysis. Background There are limited instruments available to test household risk perception and self-efficacy related to environmental health behaviours. The Household Risk Perception instrument was developed to measure personal perceptions of household environmental health risks. The Self-Efficacy in Environmental Risk Reduction instrument was designed to measure caregivers' confidence in taking steps to reduce household risks. Design An exploratory analysis of previous data was undertaken. Method Baseline data from 235 caregivers enrolled in a randomized clinical trial testing a healthy housing intervention were collected between 2006-2009. Principal components analysis was used to determine principal components from measured responses to each instrument. Results Components were explored and compared to constructs used to design the original instruments. A five-component structure showed the simplest solution and explained 65% of variance in the Household Risk Perception analysis. Cronbach's alpha values indicated satisfactory internal consistency for four of five identified components. Risk perception varied according to available sensory input of the specific risk. A four-component structure explained 64% of the variance in the Self-Efficacy in Environmental Risk Reduction analysis. Cronbach's alpha values were satisfactory. Items mapped to steps in an action-oriented process vs. agent-specific actions. Results from both analyses suggest that environmental tobacco smoke is perceived differently than other household risks. Conclusion Previously, both instruments relied on item reliability and content validity testing. This study provides a basis for further instrument revision and theoretical testing. [ABSTRACT FROM AUTHOR]

Objectives: Patients with chronic noncancer pain frequently report symptoms of depression and anxiety (negative affect), which are associated with higher ratings of pain intensity and a greater likelihood of being prescribed chronic opioid therapy. The purpose of this secondary analysis was to test the hypothesis that initial levels of negative affect can predict treatment-related outcomes in a double-blind, placebo-controlled study of extended-release (ER) hydromorphone among opioid-tolerant patients with chronic low back pain. Methods: Four hundred fifty-nine ( N = 459) patients participated in the titration/conversion phase of a multicenter study, of which 268 were randomized to receive once-daily hydromorphone or placebo. All patients completed the Hospital Anxiety and Depression Scale (HADS) at baseline and were divided evenly into Low ( N = 157), Moderate ( N = 155), and High ( N = 147) negative affect groups based on their scores. Group differences in numerical pain intensity measures at home and in the clinic, Roland-Morris Disability ratings, and measures of symptoms from the Subjective Opiate Withdrawal Scale (SOWS) throughout the trial were analyzed. Results: Two hundred sixty-eight of the initial 459 subjects who entered the 2 to 4-week titration/conversion phase (pretreatment) were successfully randomized to either placebo or ER hydromorphone; a total of 110 patients then completed this double-bflind phase of the study. Those in the Moderate and High negative affect groups tended to drop out more often during the titration/conversion phase because of the adverse effects or lack of efficacy of their prescribed opioid than those in the Low negative mood group ( P < 0.05). Overall, those patients in the Moderate and High groups reported significantly higher pain intensity scores in at-home and in-clinic pain intensity ratings ( P < 0.05), greater disability on the Roland-Morris Scale ( P < 0.01), and more withdrawal symptoms on the SOWS ( P < 0.05) than those in the Low group. Higher negative affect scores also predicted less favorable ratings of the study drug during the titration phase ( P < 0.05). Interestingly, the High negative affect group showed the most improvement in pain in the placebo condition ( P < 0.05). Conclusions: Negative affect is associated with diminished benefit during a trial of opioid therapy and is predictive of dropout in a controlled clinical trial. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Smokers who lapse during a cessation attempt are at particularly high risk of relapse, so interventions to help smokers recover from lapses are urgently needed. Two recent studies have suggested continuing to use nicotine patches following a lapse may be a beneficial relapse prevention strategy. However, to date no study that uses approved doses of nicotine patches under real-world conditions has tested this hypothesis. Design and setting Clinical trial conducted across eight US study sites. Participants and measurements Using data from 509 subjects (240 active; 269 placebo) who lapsed during weeks 3-5 of treatment in a randomized, double-blind placebo-controlled trial of 21-mg nicotine patches, we examined whether active nicotine patch use improved the chances of recovering abstinence (7-day point-prevalence) at weeks 6 and 10. Findings Active patch use (versus placebo) increased the likelihood of recovery from a lapse both at 6 weeks [8.3% versus 0.8%; relative risk (RR) = 11.0, P < 0.001] and at 10 weeks (9.6% versus 2.6%; RR = 3.7, P < 0.001). Conclusions Continuing treatment to aid smoking cessation with active patches promotes recovery from lapses. Smokers should be encouraged to persist with patch treatment if they lapse to smoking. [ABSTRACT FROM AUTHOR]

Background: Hypertension frequently coexists with diabetes mellitus, resulting in increased cardiovascular risk. Thus, BP control is crucial in decreasing morbidity and mortality in this difficult-to-treat patient population. Objective: The objective of this study was to evaluate the efficacy and safety of aliskiren in hypertensive patients with diabetes not adequately responsive to the combination of valsartan and hydrochlorothiazide (HCT). Methods: After a 1- to 4-week washout period, patients with a mean sitting diastolic BP (msDBP) ≥95mmHg were treated with valsartan 160mg for 2 weeks followed by valsartan/HCT 160mg/25mg for an additional 4 weeks (single-blind active run-in period). Patients whose msDBP remained ≥85mmHg after the active runin period were randomized (1 : 1) to receive aliskiren 150mg (n = 184) or placebo (n = 179) as add-on therapy for 6 weeks. Aliskiren was then force-titrated to 300mg once daily for another 6 weeks. Efficacy variables were: the change in msDBP and mean sitting systolic BP (msSBP) from baseline to week 12 endpoint, diastolic response (msDBP <80mmHg or reduction of at least 10mmHg), and BP control rate (<130/80mmHg). Results: Of the 363 patients randomized, 328 (90.4%) completed the study (aliskiren and placebo groups: 89.7%and 91.1%, respectively).At week 12 endpoint, the least squares mean (LSM) changes in msDBP (aliskiren vs placebo: -5.8 vs -4.8mmHg; p = 0.2767) and msSBP (aliskiren vs placebo: -7.3 vs -4.8mmHg; p = 0.0725) were numerically greater in patients treated with aliskiren compared with those treated with placebo; however, this difference was not statistically significant. The proportion of diastolic responders (aliskiren and placebo: 68.5% and 72.9%, respectively; p = 0.8482) and patients achieving BP control (aliskiren and placebo: 16.0% and 16.4%, respectively; p = 0.7511) were similar for both groups. Overall, 63 (34%) and 59 (33%) patients in the aliskiren and placebo groups, respectively, experienced adverse events (AEs). The most commonly reported AEs were headache (placebo group: 6.1%) and dizziness (aliskiren group: 4.4%). Aliskiren was well tolerated. Conclusion: The reductions in BP with aliskiren added to valsartan/HCT in this study were numerically greater compared with placebo added to valsartan/HCT, although not statistically significant. [ABSTRACT FROM AUTHOR]

Objective: Assess impact of a computer-based patient support system on quality of life in younger women with breast cancer, with particular emphasis on assisting the underserved.Design: Randomized controlled trial conducted between 1995 and 1998.Setting: Five sites: two teaching hospitals (Madison, Wis, and Chicago, Ill), two nonteaching hospitals (Chicago), and a cancer resource center (Indianapolis, Ill). The latter three sites treat many underserved patients.Participants: Newly diagnosed breast cancer patients (N = 246) under age 60.Interventions: Experimental group received Comprehensive Health Enhancement Support System (CHESS), a home-based computer system providing information, decision-making, and emotional support.Measurements and Main Results: Pretest and two post-test surveys (at two- and five-month follow-up) measured aspects of participation in care, social/information support, and quality of life. At two-month follow-up, the CHESS group was significantly more competent at seeking information, more comfortable participating in care, and had greater confidence in doctor(s). At five-month follow-up, the CHESS group had significantly better social support and also greater information competence. In addition, experimental assignment interacted with several indicators of medical underservice (race, education, and lack of insurance), such that CHESS benefits were greater for the disadvantaged than the advantaged group.Conclusions: Computer-based patient support systems such as CHESS may benefit patients by providing information and social support, and increasing their participation in health care. These benefits may be largest for currently underserved populations. [ABSTRACT FROM AUTHOR]

To elucidate processes underlying therapeutic change in a large-scale randomized clinical trial, we examined whether alterations in self-reported parenting practices were associated with the effects of behavioral, medication, or combination treatments on teacher-reported outcomes (disruptive behavior, social skills, internalizing symptoms) in children with attention-deficit hyperactivity disorder (ADHD). Participants were 579 children with Combined-type ADHD, aged 7-9.9 years, in the Multimodal Treatment Study of Children with ADHD (MTA). We uncovered 2 second-order factors of parenting practices, entitled Positive Involvement and Negative/Ineffective Discipline. Although Positive Involvement was not associated with amelioration of the school-based outcome measures, reductions in Negative/Ineffective Discipline mediated improvement in children's social skills at school. For families showing the greatest reductions in Negative/Ineffective Discipline, effects of combined medication plus behavioral treatment were pronounced in relation to regular community care. Furthermore, only in combination treatment (and not in behavioral treatment alone) was decreased Negative/Ineffective Discipline associated with reduction in children's disruptive behavior at school. Here, children in families receiving combination treatment who showed the greatest reductions in Negative/Ineffective Discipline had teacher-reported disruptive behavior that was essentially normalized. Overall, the success of combination treatment for important school-related outcomes appears related to reductions in negative and ineffective parenting practices at home; we discuss problems in interpreting the temporal sequencing of such process-outcome linkages and the means by which multimodal treatment may be mediated by psychosocial processes related to parenting. [ABSTRACT FROM AUTHOR]

The Collaborative Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (ADHD), the MTA, is the first multisite, cooperative agreement treatment study of children, and the largest psychiatric/psychological treatment trial ever conducted by the National Institute of Mental Health. It examines the effectiveness of Medication vs. Psychosocial treatment vs. their combination for treatment of ADHD and compares these experimental arms to each other and to routine community care. In a parallel group design, 579 (male and female) ADHD children, aged 7-9 years, 11 months, were randomly assigned to one of the four experimental arms, and then received 14 months of prescribed treatment (or community care) with periodic reassessments. After delineating the theoretical and empirical rationales for Psychosocial treatment of ADHD, we describe the MTA's Psychosocial Treatment strategy applied to all children in two of the four experimental arms (Psychosocial treatment alone; Combined treatment). Psychosocial treatment consisted of three major components: a Parent Training component, a two-part School Intervention component, and a child treatment component anchored in an intensive Summer Treatment Program. Components were selected based on evidence of treatment efficacy and because they address comprehensive symptom targets, settings, comorbidities, and functional domains. We delineate key conceptual and logistical issues faced by clinical researchers in design and implementation of Psychosocial research with examples of how these issues were addressed in the MTA study. [ABSTRACT FROM AUTHOR]