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The authors investigate the effects of centering meditation on state hope among college and graduate students through a randomized controlled trial. Participants (n = 150; 65% white, 84% female) were randomized to either a centering meditation group or a waitlist control group. Time‐series analyses indicated that centering meditation significantly improved hope, suggesting long‐term dynamic adjustment, compared to a control group. Specifically, the autoregressive integrated moving average (ARIMA) procedures indicated that the treatment group exhibited a statistically significant upward trend in hope, ARIMA (1, 1, 0). As expected, the control group's levels of hope were stationary, ARIMA (1, 0, 1). The study highlights the potential benefits of centering meditation as an evidence‐based counseling intervention for improving hope in the college population. [ABSTRACT FROM AUTHOR]

Background and Aims: There is little RCT evidence that brief interventions improve treatment seeking in individuals with severe alcohol use disorder (AUD) or treatment seeking reduces alcohol use. The aim was to test the efficacy of a brief intervention to increase treatment seeking in treatment naïve adults with severe AUD and measure its effects on alcohol use. Design: Parallel group, non‐pharmacologic RCT with intervention (n = 197) and active control (n = 203) conditions, with blinded assessors conducting follow‐ups at 1, 3 and 6 months. Setting: Online recruitment in a 17‐county region of upstate New York, USA. Participants: Inclusion criteria consisted of ages ≥18 years, Alcohol Use Disorders Identification Test score ≥16, exceeds recommended limits for alcohol use and no history of AUD treatment. n = 400; 50% female; 79% white; mean age, 40.7; mean education, 14.6 years. Intervention and comparator: One‐session telephone‐delivered interventions: Cognitive‐Behavioral Therapy for Treatment Seeking (CBT‐TS; intervention), review of a National Institute on Alcohol Abuse and Alcoholism pamphlet on AUD treatment (control). Measurements Self‐report of any AUD treatment use over 3 months (primary outcome) and two standard measures of alcohol use over 6 months (secondary outcomes). Findings Intent‐to‐treat analyses were used. Assessment follow‐up rates were ≥93%. Any alcohol‐related treatment use over 3‐month follow‐up was obtained by 38 (19%) intervention participants and 36 (18%) control participants, a non‐significant difference, χ2 [1] = 0.16, P = 0.689. Secondary analysis showed a significant interaction term between sex and intervention assignment (β = −1.197, P = 0.027). The interaction suggested CBT‐TS was effective in men (22% vs 13%), although the evidence was somewhat weak (P = 0.071), and it was not effective in women (17% vs 24%). Conclusions: A one‐session cognitive‐behavioral therapy intervention to increase treatment seeking in treatment naïve adults with severe alcohol use disorder did not increase treatment seeking. [ABSTRACT FROM AUTHOR]

To determine the racial and ethnic compositions of the participants in obstetric randomized controlled trials (RCTs) and compare them to the US general population. RCTs published in two premier US journals, American Journal of Obstetrics and Gynecology, Obstetrics and Gynecology from January 2010 to April 2020 were analyzed. The racial and ethnic distributions of the study participants were extracted and expressed as percentages for each article. Obstetrics articles were selected and then further divided into subcategories. Statistical analyses were performed on racial and ethnicity representation in each subcategory compared to a US population norm. Overall, a wide variation of racial and ethnic distribution was noted among studies. However, statistically significant overrepresentation of Non-Hispanic Black population and underrepresentation of White and Asian races were noted while Hispanic population's representation was comparable to the US general population. This observation was persistent across most of the subcategories. RCTs in the field of Obstetrics showed an overrepresentation of Black population. This observation was unique when we consider the previous reports in other fields of medicine. These findings should be taken into consideration when interpreting the results of RCTs conducted in US. [ABSTRACT FROM AUTHOR]

Background: Prostate cancer is the third most prevalent cancer in the American population. Furthermore, the prognosis is worse in African American as there is increased morbidity and mortality associated with it.Purpose: The purpose of this study is to evaluate the effectiveness of a new online method to educate the patient population regarding prostate cancer risk, diagnosis, treatments, and their decisions about whether to be screened for the early detection of prostate cancer.Methods: Two hundred Black male patients are recruited from different clinical sites and randomized to either the control arm (usual care) or the intervention arm (educational program). We will compare the effectiveness of the intervention to see if patients are discussing the need of getting a prostate-specific antigen (PSA) test, and the possible benefits and harms that may result of having or not having the test, with their primary care providers.Discussion: Shared decision-making (SDM) is the current standard in most cancer-screening guidelines and also a standard of person-centered care. However, there is a lack of evidence-based approaches to improve decision quality in clinical settings and an increased ambiguity of applying SDM for PSA-based screening among Black men in primary care. Our proposal to evaluate a decisional-aid intervention and measure the actual application of SDM during clinical encounters has a high potential to advance the translation path of implementing shared decision-making in clinical settings and provide evidence of the applicability of the guideline in general.Innovation and Overall Impact: Given the 2018 USPSTF updated guidelines recommending shared decision-making about PSA-based screening, the increased risk of prostate cancer mortality in Black men, the challenges of evidence-based decision-making due to the underrepresentation of Blacks in major randomized clinical trials, and implicit racial bias among primary care providers, the time is ripe for interventions to improve shared decision-making about prostate cancer screening in Black men. In this study, we address communication and knowledge gaps between Black men and their primary care providers. The intervention, if proven effective, can be readily scaled across primary care practices across the U.S. and may be adapted to other types of cancer where guidelines have included shared decision-making as well. Early detection of prostate cancer may decrease mortality and morbidity in the long term. [ABSTRACT FROM AUTHOR]

Objective: Suicide is a major public health concern in the United States, but few effective and scalable interventions exist to help those with suicidal thoughts. We hypothesized that reading first-person narratives about working through suicidal thoughts would reduce the desire to die among adults and that this effect would be mediated by increased perceived shared experience and optimism. Method: Using a randomized waitlist-controlled trial, we tested the effect of digital narrative-based bibliotherapy among 528 adults visiting a social media platform dedicated to providing mental health support. Participants were randomized to either a treatment condition (n = 266), in which they read one suicide narrative per day for 14 days or to a waitlist control condition (n = 262). The primary outcome was a measure of desire to die assessed daily for the 14-day trial period and at 2-week follow-up. Results: Participants in the treatment condition reported lower desire to die than participants in the control condition during the 14-day trial period (β = −0.26, p =.001) and at 2-week follow-up (t = −2.82, p =.005). Increased perceived shared experience (indirect effect b = −0.55, p <.001) and optimism (indirect effect b = −0.85, p <.001) mediated the effect of treatment on desire to die. Conclusions: Digital narrative-based bibliotherapy may be an effective intervention for those at risk for suicide, and may work in part by increasing feelings of perceived shared experience and optimism. Future research is needed to test the generalizability of these results to other platforms, groups, and conditions. What is the public health significance of this article?: This study demonstrates that reading user-generated narratives about experiences with and recovery from suicidal thoughts/behaviors may be an effective and scalable way to help people experiencing suicidal thoughts. [ABSTRACT FROM AUTHOR]

Background: Hispanic/Latinx smokers living in the United States face unique challenges in quitting smoking. This study evaluated the efficacy of a culturally relevant, Spanish‐language, extended self‐help smoking cessation intervention among Hispanic smokers. Methods: A 2‐arm parallel randomized controlled trial was conducted with Hispanic/Latinx smokers living in the United States who preferred health information in Spanish and smoked 5 or more cigarettes per week. Participants were randomly allocated to receive Libre del Cigarrillo (LDC), which consisted of 11 booklets and 9 pamphlets mailed monthly over 18 months, or the usual care (UC), which was a single Spanish‐language self‐help booklet from the National Cancer Institute. The primary outcome was self‐reported 7‐day point prevalence smoking abstinence assessed 6, 12, 18, and 24 months after the baseline. Eight prespecified moderators of the intervention were evaluated. Cost‐effectiveness was also evaluated. All statistical tests were 2‐sided. Results: Data from all participants randomized to LDC (n = 714) or UC (n = 703) were used for analyses after multiple imputation to manage missing data. Generalized estimating equation analyses indicated that LDC abstinence rates were higher (P <.001) across all assessments. Logistic regression analyses revealed that at 24 months, the abstinence rate was greater for LDC (33.1%) than UC (24.3%; odds ratio, 1.54; 95% confidence interval, 1.18‐2.02; P =.002). Men exhibited a strong intervention effect at all assessments (P values <.001), whereas the intervention effect for women was observed only at 6 and 12 months (P values <.018). In comparison with UC, the incremental cost per quitter in the LDC arm was $648.43 at 18 months and $683.93 at 24 months. Conclusions: A culturally relevant, Spanish‐language intervention was efficacious and cost‐effective for smoking cessation. Lay Summary: Research is needed to develop interventions for ethnic minority smokers.The aim of the current study was to test a Spanish‐language adaptation of a validated and easily implemented self‐help smoking cessation intervention in a nationwide randomized controlled trial.The findings demonstrated that the intervention produced greater smoking abstinence in comparison with a standard self‐help booklet.Participants also were more satisfied with the intervention, and it was cost‐effective.Efforts aimed at promoting tobacco abstinence in this underserved population could have significant public health implications, including potential reductions in cancer health disparities associated with tobacco smoking. This large, nationwide randomized controlled trial demonstrates that a culturally relevant, Spanish‐language, extended self‐help intervention is efficacious and cost‐effective for smoking cessation, and it supports the tailoring of interventions to Hispanics by identifying and integrating cultural values. The evaluated intervention approach has potential for broad dissemination and reach to reduce cigarette smoking and has implications for cancer prevention because smoking is the primary risk factor for lung cancer, which is the leading cause of cancer death among Hispanic men and is second only to breast cancer among Hispanic women. [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]

Prostate cancer incidence and mortality in the United States in African Americans (AA) are higher than in Caucasians. Eastern Cuyahoga County in Ohio is majority AA and is considered an underserved population particularly vulnerable to healthcare disparities. There is a paucity of data about shared decision making among high-risk AA men with regard to prostate cancer screening. This study aims to examine shared versus informed decision making (SDM versus IDM) in a randomized, control trial among a large, high-risk AA population. Patients were included in annual one-day outreach events, each held over 3 years (2017–2019), and were randomized at each event into IDM (control) and SDM (investigational) groups and then were offered screening via prostate specific antigen (PSA) and digital rectal exam (DRE). The primary endpoints were proportion of participants over 40 who did not demonstrate decisional conflict about prostate cancer screening measured by the SURE score, as well as change of knowledge score about prostate cancer screening. Overall, 175 patients were enrolled in the trial; 79 in the SDM arm and 96 in the IDM arm. The investigational (SDM) arm had 3/79 (3.9%) conflict versus 6/96 (6.4%) in the control (IDM) arm (p = 0.74). With regard to knowledge improvement, the SDM cohort demonstrated improvement following educational tools for 66/79 (81%) of participants versus 76/96 (79%) in the IDM cohort (p = 0.85). There was no difference in the proportion (63%) of participants in either group who found the information very helpful (using a Likert scale). Our education-based study showed no significant difference between SDM and IDM with regard to decisional conflict about prostate cancer screening. The study also demonstrated significant improvement in knowledge about prostate cancer screening in a high-risk AA population in both groups. Our results should be interpreted with caution due to several limitations; however, the study can serve as a benchmark for future studies in this very important topic. [ABSTRACT FROM AUTHOR]

Introduction: Adolescent dating violence (ADV), including psychological, physical, threatening, and/or sexual abuse between adolescent romantic partners, is an epidemic in the United States, with youth report rates ranging from 15 to 77% for perpetration and 14-73% for victimization. ADV victimization is associated with multiple adverse outcomes in both adolescence and adulthood (e.g., suicidal ideation, substance use, bullying), as is ADV perpetration (e.g., sexually transmitted infections, intimate partner violence in adulthood). Given the high prevalence and profound impact of ADV on youth in the US, many prevention efforts have emerged in the past 20 years. Previous reviews of these efforts have focused primarily on school-based interventions or have broadly reviewed programs including all research design types and outcomes. This review is the first to provide a comprehensive, quantitative synthesis of all existing ADV prevention programs tested using randomized controlled trial designs with a control group, specifically measuring ADV perpetration and/or victimization as outcomes.Methods: Employing a systematic literature search and screening protocol, nine studies were identified for meta-analysis.Results: Results indicate that ADV prevention programs may decrease the risk of emotional, physical, and sexual perpetration, as well as emotional and physical victimization.Conclusions: This is the first review to uncover significant intervention effects on the actual occurrence of ADV, with previous reviews only finding effects on outcomes such as ADV knowledge and attitude. Findings suggest that ADV prevention programs are promising and may warrant implementation more broadly with youth, and this review provides methodological suggestions for future research evaluating new ADV prevention programs. [ABSTRACT FROM AUTHOR]

Type 1 diabetes (T1D) is a chronic condition affecting nearly 1.9 million people in the United States. Young adults (YAs) with T1D face unique challenges in managing their condition, experiencing poorer health and well-being than other age groups. The current study is evaluating the Resilient, Empowered, Active Living (REAL) intervention, previously shown to improve glucose levels and quality of life among YAs with diabetes, using telehealth delivery (REAL-T) to expand reach and accessibility. This paper reports on the methodology and baseline participant characteristics of the REAL-T study. REAL-T is a two-arm randomized controlled trial that recruited 18–30 year olds with T1D via clinics and social media advertising. Data collection, which was adapted to be fully remote due to COVID-19, occurs every three months for one year. Participants receive either usual care or a 6-month telehealth occupational therapy intervention. The primary outcome is glycated hemoglobin (A1c); secondary outcomes include diabetes distress, quality of life, and continuous glucose monitor-derived measures. The study enrolled a diverse sample of 209 YAs with T1D. Analysis of baseline data indicates equivalence between the intervention and control groups. Study participants have notably higher diabetes distress and poorer mental well-being than similar populations. The REAL-T study successfully adapted to remote implementation during the COVID-19 pandemic. By examining long-term outcomes, mediating pathways, and cost-effectiveness, the study will contribute knowledge of the impact of tailored interventions for YAs with T1D, designed to reduce disparities and improve health and well-being in this population. [ABSTRACT FROM AUTHOR]

Individuals with a recent suicidal crisis are typically admitted for inpatient psychiatric care. However, targeted inpatient interventions for suicide prevention remain sparse. Thus, this pilot randomized controlled trial evaluated a brief inpatient cognitive behavioral protocol, Post-Admission Cognitive Therapy (PACT) for the prevention of suicide. United States service members and beneficiaries (N = 24) psychiatrically hospitalized at a military medical center due to a recent suicidal crisis were randomized to receive either PACT plus Enhanced Usual Care (PACT + EUC) or EUC alone. Blinded follow-up assessments were conducted at one-, two-, and three-months post discharge. The degree of change and variability of response to PACT for repeat suicide attempt(s) (primary outcome), as well as depression, hopelessness, and suicide ideation (secondary outcomes) were examined. Significant between-group differences in re-attempt status were not found. Reliable Change Index analyses indicated that among the most clinically severe participants, a greater proportion of PACT + EUC participants compared with EUC participants met criteria for clinically significant reductions on depression (40% versus 25%), hopelessness (67% versus 50%), suicide ideation (45% versus 33%), and posttraumatic stress symptomatology (40% versus 25%). PACT is a promising inpatient cognitive behavioral intervention for suicide risk reduction. The efficacy of PACT is currently being evaluated in a well-powered multi-site randomized controlled trial. [ABSTRACT FROM AUTHOR]

Background: To reduce cardiovascular disease (CVD) risk, we tested an online intervention to improve healthy lifestyle for women with recent preeclampsia. Materials and Methods: We conducted a randomized controlled 9-month clinical trial, Heart Health 4 Moms (HH4M), among 151 U.S. women with preeclampsia within 5 years. Sample size was planned to detect differences of 0.5 standard deviation units in primary outcomes between study arms. Preeclampsia history was validated by medical records; women with chronic hypertension were excluded. The intervention included online educational modules, a community forum, and communication with a lifestyle coach. The control group received internet links to CVD risk reduction information. Primary outcomes were self-efficacy to eat a healthy diet and increase physical activity; change in physical in/activity; adherence to the Dietary Approaches to Stop Hypertension (DASH) diet; and knowledge of and personal control over CVD risk. Secondary outcomes were weight and blood pressure. Results: In the intervention arm, 84% of participants accessed at least one online educational module; 89% completed at least three scheduled calls with the coach. At 9 months, intervention participants reported significantly greater knowledge of CVD risk factors (corrected p = 0.01), increased self-efficacy for healthy eating (p = 0.03), and less physical inactivity than controls (p = 0.0006). The groups did not differ in sense of personal control of CVD risk factors, adherence to the DASH diet, self-efficacy for physical activity, or reported physical activity. There were no differences in secondary outcomes between groups. Conclusions: The HH4M program improved CVD risk knowledge, self-efficacy to achieve a healthy diet, and reduced physical inactivity among women with recent preeclampsia. [ABSTRACT FROM AUTHOR]

Although unhealthy alcohol use is associated with increased morbidity and mortality among people with HIV (PWH), many are ambivalent about engaging in treatment and experience variable responses to treatment. We describe the rationale, aims, and study design for the F inancial I ncentives, R andomization, with S tepped T reatment (FIRST) Trial, a multi-site randomized controlled efficacy trial. PWH in care recruited from clinics across the United States who reported unhealthy alcohol use, had a phosphatidylethanol (PEth) >20 ng/mL, and were not engaged in formal alcohol treatment were randomized to integrated contingency management with stepped care versus treatment as usual. The intervention involved two steps; Step 1 : Contingency management (n = 5 sessions) with potential rewards based on 1) short-term abstinence; 2) longer-term abstinence; and 3) completion of healthy activities to promote progress in addressing alcohol consumption or conditions potentially impacted by alcohol; Step 2 : Addiction physician management (n = 6 sessions) plus motivational enhancement therapy (n = 4 sessions). Participants' treatment was stepped up at week 12 if they lacked evidence of longer-term abstinence. Primary outcome was abstinence at week 24. Secondary outcomes included alcohol consumption (assessed by TLFB and PEth) and the Veterans Aging Cohort Study (VACS) Index 2.0 scores; exploratory outcomes included progress in addressing medical conditions potentially impacted by alcohol. Protocol adaptations due to the COVID-19 pandemic are described. The FIRST Trial is anticipated to yield insights on the feasibility and preliminary efficacy of integrated contingency management with stepped care to address unhealthy alcohol use among PWH. ClinicalTrials.gov identifier: NCT03089320. • People with HIV (PWH) often are ambivalent about engaging in treatment of unhealthy alcohol use. • Contingency management holds promise for reducing unhealthy alcohol use among PWH. • Stepped care strategies are important given lack of consistent response to alcohol treatments. [ABSTRACT FROM AUTHOR]

Introduction: This study compared changes in sleep disturbance over time across brief cognitive behavioral therapy for suicide prevention and treatment as usual and examined the mechanisms that link sleep disturbance with several suicide risk factors.Method: Active duty U.S. Army soldiers (N = 152) completed a randomized controlled trial to test the efficacy of brief cognitive behavioral therapy (n = 76) or treatment as usual (n = 76). Six assessments of insomnia symptoms, hopelessness, coping, and suicide beliefs were tracked over 24 months.Results: Brief cognitive behavioral therapy patients reported a significant decrease in sleep disturbance symptoms over time while treatment as usual patients did not. These improvements were initially observed during treatment and carried over through 12-months. Changes in sleep disturbance predicted changes in suicide risk. Longitudinal growth modeling was used to assess potential mechanisms of this effect. Results suggested that changes in cognitive flexibility, as defined by measures of hopelessness and suicide beliefs, predicted change in sleep disturbance symptoms. These relationships did not differ across treatment groups.Limitations: The participants were active duty military personnel. Therefore, the results may not generalize to other patient populations. A greater number of assessment periods in closer proximity as well as additional measures of constructs of interest would have improved the internal validity of this study.Conclusions: Brief cognitive behavioral therapy significantly reduces sleep disturbance and suicide risk. Changes in cognitive flexibility, in part, explain change in sleep disturbance across both treatments. [ABSTRACT FROM AUTHOR]

Objective: Given the global and economic burden of stroke as a major cause of long-term disability, patient-reported outcomes (PRO) data from clinical trials can elucidate differential benefits/harms of interventions from patients' perspectives and influence clinical decision making in stroke care management.Methods: This systematic review examines stroke-related randomized controlled trials (RCT) published in 12 high-impact journals between 2002 and 2016 for (1) associations between trial characteristics and the reporting of PRO measures; and (2) psychometric properties of PRO instruments used in these studies. The study combines clinical trials identified in a prior review with trials identified with an updated literature search.Results: Only 34 of 159 stroke-related RCTs reported PRO measures. Among the 34 trials, most were published in rehabilitation and general medical journals, were conducted in the United States or Europe, were funded by government/non-industry sponsors, and focused on post-stroke care. Thirty-one PRO instruments were employed in these studies. Only 5 instruments were stroke-specific measures, whereas the remaining 26 instruments were generic measures. Eight instruments assessed functional status, 9 measured quality of life, and 14 assessed symptoms. The most common health domains measured were emotional status and physical function.Conclusions: This study highlights the paucity of information from patients' perspective in stroke-related RCTs. This trend may change over time as researchers increase adherence to reporting guidelines for clinical trial protocols. [ABSTRACT FROM AUTHOR]

Background: Ischemic stroke has no approved treatments to enhance recovery. ALD-401 is an enriched population of aldehyde dehydrogenase-bright stem cells, capable of reducing neurological deficits in animal models. The primary objective of this trial was to determine the safety of internal carotid artery, intra-arterially delivered autologous bone marrow-derived ALD-401 in patients with disabling middle cerebral artery stroke in comparison with sham harvest with sham infusion. Secondary objectives were to determine feasibility and efficacy.Methods: This was a prospective phase 2, industry-funded, randomized, sham-controlled, parallel-group, multicenter study with blinded assessments. One hundred subjects were planned, aged 30 to 83 years, with confirmed first-time middle cerebral artery ischemic stroke with modified Rankin scale ≥3. Study patients were randomly assigned 3:2 to bone marrow harvest at 11 to 17 days after stroke followed 2 days later by intracarotid infusion of ALD-401 versus sham harvest and then sham infusion in the same timeframe. The primary study outcome was safety based on the incidence of a 4-point National Institutes of Health Stroke Scale worsening and the proportion of serious adverse events. Efficacy was based on modified Rankin scale change at 90 days. Other secondary outcomes were the proportions of patients experiencing adverse events, disability by Barthel Index, quality of life using EQ-5D, rehabilitation utilization, disability at 1 year, and MRI evidence of complications.Results: There were no infusional or allergic reactions and no difference in treatment emergent adverse events. Four patients had small areas of asymptomatic restricted diffusion on MRI in the treatment group. There was no significant difference between the ALD-401 and placebo groups on the modified Rankin scale for the intent-to-treat population at day 90 (mean difference, 0.3; 95% CI, -0.3 to 0.8; P=0.330). There were no significant differences between the groups on any of the secondary efficacy measures.Conclusions: Intracarotid infusion of ALD-401 does not lead to clinical adverse events in patients with subacute ischemic stroke, although there was a higher incidence of small lesions on MRI in the treatment group. There was no difference in the primary efficacy end point between the groups. The study provides a framework for the design and conduct of future intra-arterial cell therapy trials in stroke.Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01273337. [ABSTRACT FROM AUTHOR]

The purpose of this study was to evaluate child abuse prevention campaign materials. Using a randomized posttest design, 600 parents from an online research panel were recruited and surveyed. Multiple regression results indicate that exposure to the campaign materials had a significant relationship with four of the five domains (effects of child maltreatment, the appropriateness of harsh parenting, the physical dangers and needs unique to childhood, and the power to prevent child maltreatment). These results have implications for the child abuse prevention practitioners who seek to design and distribute effective campaign materials. [ABSTRACT FROM AUTHOR]

Objectives: To determine whether intervention‐induced physical activity (PA) changes in sedentary older adults differed according to dopamine‐related genotype. Design: Randomized clinical trial (Lifestyle Interventions and Independence for Elders Trial (2010–13)). Setting: Multicenter study, 8 U.S. locations. Participants: Volunteer sample of sedentary adults aged 70 to 89 at risk of disability (N=1635). Interventions: Structured PA versus health education (HE) for an average of 2.6 years. Measurements: Single‐nucleotide polymorphisms of dopamine‐related genes (dopamine receptor (DR) D1, DRD2, DRD3, and catechol‐O‐methyltransferase (COMT)) were assessed. Average moderate to vigorous PA (MVPA) was calculated using accelerometry (min/d) at baseline and 6, 12, and 24 months. Between‐arm MVPA differences according to genotype and genotype with square root–transformed MVPA separately according to arm were tested, stratified according to race, and adjusted for multiple comparisons. Results: White participants in the PA arm (n=513) had higher average square root transformed MVPA (4.91±1.91)than those in the HE arm (n=538) (4.51±1.82) (p=.001). Between‐arm differences were greater for DRD2 Met/Met (high dopamine; HE: 4.76±1.80, PA: 5.53±1.60, p=.03) than Val/Val (low dopamine; HE: 4.58±1.92, PA: 4.81±1.83, p=.16); results were similar for COMT. In the PA arm, DRD2 Met/Met was associated with higher average MVPA (5.39±2.00) than Met/Val (4.46±2.51) (p=.01) and Val/Val (4.65±2.71) (p=.01). There were no associations for other genes. Associations were not significant in blacks but followed similar trends. Conclusion: Higher dopamine signaling may support changes in PA during an intervention. The role of dopamine‐related pathways in promoting PA participation and enhancing response to interventions in sedentary older adults should be studied. Trial Registration: clinicaltrials.gov Identifier: NCT01072500 [ABSTRACT FROM AUTHOR]

Background: General Surgery is currently the fastest growing specialty with regards to robotic surgical system utilization. Contrary to the experience in laparoscopy, simulator training for robotic surgery is not widely employed partly because robotic surgical simulators are expensive. We sought to determine the effect of a robotic simulation curriculum and whether robotic surgical skills could be derived from those psychomotor skills attained in laparoscopic training.Methods: Twenty-seven trainees with no prior robotic experience and limited laparoscopy exposure were randomly assigned to one of three training groups: no simulator training, training on a fundamentals of laparoscopic surgery (FLS™) standard box trainer, and training on a robotic computer based simulator (da Vinci Skills Simulator™). Baseline robotic surgical skills were assessed on the clinical robot docked to a standard FLS trainer box on two tasks-intracorporeal knot tying and peg transfer. Subjects subsequently underwent four 1-h long training sessions in their assigned training environment over a course of several weeks. Robotic surgical skills were reassessed on the robot on the same two tasks used to assess skills prior to training.Results: FLS training resulted in a greater score improvement than no training for both knot and peg scores. FLS training was also determined to result in greater score improvement than robotic simulator training for knot tying. There was no significant difference in peg transfer or knot tying scores when comparing robotic simulator training and no training.Conclusions: Robotic surgical skills can be in part derived from psychomotor skills developed in a laparoscopic trainer, especially for complex skills such as intracorporeal knot tying. Acquisition of robotic surgical skills may be enhanced by practice on a laparoscopic simulator using the FLS curriculum. This may be especially helpful when a robotic simulator is not available or is poorly accessible. [ABSTRACT FROM AUTHOR]

Background: In nonrandomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), fewer symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and midrange or preserved ejection fraction (EF ≥40%). We conducted the first randomized sham-controlled trial to evaluate the IASD in HF with EF ≥40%.Methods: REDUCE LAP-HF I (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association class III or ambulatory class IV HF, EF ≥40%, exercise PCWP ≥25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg. Participants were randomized (1:1) to the IASD versus a sham procedure (femoral venous access with intracardiac echocardiography but no IASD placement). The participants and investigators assessing the participants during follow-up were blinded to treatment assignment. The primary effectiveness end point was exercise PCWP at 1 month. The primary safety end point was major adverse cardiac, cerebrovascular, and renal events at 1 month. PCWP during exercise was compared between treatment groups using a mixed-effects repeated measures model analysis of covariance that included data from all available stages of exercise.Results: A total of 94 patients were enrolled, of whom 44 met inclusion/exclusion criteria and were randomized to the IASD (n=22) and control (n=22) groups. Mean age was 70±9 years, and 50% were female. At 1 month, the IASD resulted in a greater reduction in PCWP compared with sham control (P=0.028 accounting for all stages of exercise). Peak PCWP decreased by 3.5±6.4 mm Hg in the treatment group versus 0.5±5.0 mm Hg in the control group (P=0.14). There were no peri-procedural or 1-month major adverse cardiac, cerebrovascular, and renal events in the IASD group and 1 event (worsening renal function) in the control group (P=1.0).Conclusions: In patients with HF and EF ≥40%, IASD treatment reduces PCWP during exercise. Whether this mechanistic effect will translate into sustained improvements in symptoms and outcomes requires further evaluation.Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT02600234. [ABSTRACT FROM AUTHOR]

Background: 13-Cis retinoic acid (13-CRA) is a synthetic vitamin A derivative. High-dose 13-CRA in patients with squamous cell cancers of the head and neck (SCCHNs) reduces the incidence of second primary tumors (SPTs). The authors report long-term results from a phase 3 randomized trial that compared treatment with low-dose 13-CRA versus placebo for patients who had early stage SCCHN, with a focus on the development of SPTs and overall survival (OS).Methods: In total, 176 patients who received treatment for stage I/II SCCHN were randomized to receive either low-dose 13-CRA (weight-based dose of 7.5 mg or 10 mg) or placebo for 2 years. A competing-risk approach and the log-rank test were used to compare the time to SPT and OS, respectively, between groups.Results: 13-CRA neither significantly reduced the cumulative incidence of SPT (P = .61) nor improved the time to SPT (hazard ratio [HR] for 13-CRA/placebo; 0.86; P = .61). Despite limited power, there was a trend toward improved OS for the 13-CRA arm (HR, 0.75; P = .14), particularly among patients whose index tumor was surgically excised (N = 26; HR, 0.50; P = .057) and among women (N = 39; HR, 0.44; P = .065) and never/former smokers (N = 129; HR, 0.61; P = .055), with a median follow-up of 16 years. The main 13-CRA related toxicities were dry skin and cheilitis.Conclusions: Treatment with low-dose 13-CRA for 2 years did not decrease the incidence of SPT; subset analysis indicates a potential survival advantage among patients who are women and never/former smokers. More targeted interventions based on clinical risk factors and molecular characterization of tumors may yield greater success in future prevention trials. Cancer 2017;123:4653-4662. © 2017 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background: QUIT is the only primary care-based brief intervention that has previously shown efficacy for reducing risky drug use in the United States (Gelberg et al., 2015). This pilot study replicated the QUIT protocol in one of the five original QUIT clinics primarily serving Latinos.Design: Single-blind, two-arm, randomized controlled trial of patients enrolled from March-October 2013 with 3-month follow-up.Setting: Primary care waiting room of a federally qualified health center (FQHC) in East Los Angeles.Participants: Adult patients with risky drug use (4-26 on the computerized WHO ASSIST): 65 patients (32 intervention, 33 control); 51 (78%) completed follow-up; mean age 30.8 years; 59% male; 94% Latino.Interventions and Measures: Intervention patients received: 1) brief (typically 3-4 minutes) clinician advice to quit/reduce their risky drug use, 2) video doctor message reinforcing the clinician's advice, 3) health education booklet, and 4) up to two 20-30 minute follow-up telephone drug use reduction coaching sessions. Control patients received usual care and cancer screening information. Primary outcome was reduction in number of days of drug use in past 30days of the highest scoring drug (HSD) on the baseline ASSIST, from baseline to 3-month follow-up.Results: Controls reported unchanged HSD use between baseline and 3-month follow-up whereas Intervention patients reported reducing their use by 40% (p<0.001). In an intent-to-treat linear regression analysis, intervention patients reduced past month HSD use by 4.5 more days than controls (p<0.042, 95% CI: 0.2, 8.7). Similar significant results were found using a complete sample regression analysis: 5.2 days (p<0.03, 95% CI: 0.5, 9.9). Additionally, on logistic regression analysis of test results from 47 urine samples at follow-up, intervention patients were less likely than controls to test HSD positive (p<0.05; OR: 0.10, 95% CI: 0.01, 0.99).Conclusions: Findings support the efficacy of the QUIT brief intervention for reducing risky drug use. [ABSTRACT FROM AUTHOR]

To help create an evidence base in Europe for effective interventions that improve the well-being of homeless people, we tested whether critical time intervention ( CTI), a time-limited intervention developed to support vulnerable people during times of transition, is effective outside the United States. For this multicenter, parallel-group randomized controlled trial, 183 adults who were moving from shelters in the Netherlands to supported or independent housing were allocated to CTI or care-as-usual. The primary outcome was number of days rehoused, which was assessed by interviewing participants four times during a 9-month follow-up. Outcomes were analyzed with three-level mixed-effects models. The primary outcome did not differ between groups. CTI had a significant effect on family support and, for people experiencing less social support, psychological distress. Groups did not differ significantly on social support, fulfillment of care needs, quality of life, self-esteem, excessive alcohol use, or cannabis use. Because few participants were homeless at 9 months, more research is needed to establish whether CTI can prevent long-term recurrent homelessness. Given recent emphasis on informal support in public services and positive effects of CTI on family support and psychological distress, CTI is a fitting intervention for Dutch shelter services. [ABSTRACT FROM AUTHOR]

Objectives To assess the effects of bimagrumab on skeletal muscle mass and function in older adults with sarcopenia and mobility limitations. Design A 24-week, randomized, double-blind, placebo-controlled, parallel-arm, proof-of-concept study. Setting Five centers in the United States. Participants Community-dwelling adults (N = 40) aged 65 and older with gait speed between 0.4 and 1.0 m/s over 4 m and an appendicular skeletal muscle index of 7.25 kg/m2 or less for men and 5.67 kg/m2 or less for women. Intervention Intravenous bimagrumab 30 mg/kg (n = 19) or placebo (n = 21). Measurements Change from baseline in thigh muscle volume (TMV), subcutaneous and intermuscular fat, appendicular and total lean body mass, grip strength, gait speed, and 6-minute walk distance (6MWD). Results Thirty-two (80%) participants completed the study. TMV increased by Week 2, was sustained throughout the treatment period, and remained above baseline at the end of study in bimagrumab-treated participants, whereas there was no change with placebo treatment (Week 2: 5.15 ± 2.19% vs −0.34 ± 2.59%, P < .001; Week 4: 6.12 ± 2.56% vs 0.16 ± 3.42%, P < .001; Week 8: 8.01 ± 3.70% vs 0.35 ± 3.32%, P < .001; Week 16: 7.72 ± 5.31% vs 0.42 ± 5.14%, P < .001; Week 24: 4.80 ± 5.81% vs −1.01 ± 4.43%, P = .002). Participants with slower walking speed at baseline receiving bimagrumab had clinically meaningful and statistically significantly greater improvements in gait speed (mean 0.15 m/s, P = .009) and 6MWD (mean 82 m, P = .022) than those receiving placebo at Week 16. Adverse events in the bimagrumab group included muscle-related symptoms, acne, and diarrhea, most of which were mild in severity and resolved by the end of study. Conclusion Treatment with bimagrumab over 16 weeks increased muscle mass and strength in older adults with sarcopenia and improved mobility in those with slow walking speed. [ABSTRACT FROM AUTHOR]

Objectives To determine effects of Sit 'N' Fit Chair Yoga, compared to a Health Education program ( HEP), on pain and physical function in older adults with lower extremity osteoarthritis ( OA) who could not participate in standing exercise. Design Two-arm randomized controlled trial. Setting One HUD senior housing facility and one day senior center in south Florida. Participants Community-dwelling older adults (N = 131) were randomly assigned to chair yoga (n = 66) or HEP (n = 65). Thirteen dropped after assignment but prior to the intervention; six dropped during the intervention; 106 of 112 completed at least 12 of 16 sessions (95% retention rate). Interventions Participants attended either chair yoga or HEP. Both interventions consisted of twice-weekly 45-minute sessions for 8 weeks. Measurements Primary: pain, pain interference; secondary: balance, gait speed, fatigue, functional ability measured at baseline, after 4 weeks of intervention, at the end of the 8-week intervention, and post-intervention (1 and 3 months). Results The chair yoga group showed greater reduction in pain interference during the intervention ( P = .01), sustained through 3 months ( P = .022). WOMAC pain ( P = .048), gait speed ( P = .024), and fatigue ( P = .037 ) were improved in the yoga group during the intervention ( P = .048) but improvements were not sustained post intervention. Chair yoga had no effect on balance. Conclusion An 8-week chair yoga program was associated with reduction in pain, pain interference, and fatigue, and improvement in gait speed, but only the effects on pain interference were sustained 3 months post intervention. Chair yoga should be further explored as a nonpharmacologic intervention for older people with OA in the lower extremities. Trial Registration: ClinicalTrials.gov: NCT02113410. [ABSTRACT FROM AUTHOR]

Aims To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. Design A parallel-group randomized controlled trial of brief motivational ( n = 185), reduction ( n = 186) or usual care ( n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. Setting United States. Participants A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. Measurements The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. Findings A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Conclusions Among adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months. [ABSTRACT FROM AUTHOR]

Background The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Fresh Start (WFS) is a randomized controlled trial of nutrition education to promote farmers’ market fruit and vegetable (F/V) purchases and consumption among women enrolled in WIC. Objectives To describe the baseline characteristics (demographics and F/V intake [including F/V juice]) of WFS participants, compare the characteristics with those of WIC participants in New Jersey and nationwide, and examine the baseline reliability of study measures. Design Cross-sectional. Participants/setting Seven hundred forty-four women served by a New Jersey–based WIC agency located in a densely populated, urban area. Main outcome measures Demographic characteristics; newly developed measures of farmers’ market–related knowledge, attitudes, and skills; and validated measures of F/V intake. Statistical analyses Descriptive statistics to characterize the sample. One-sample t and one-sample sign tests to compare the characteristics with reference values. For dietary behaviors, comparisons were with state and national estimates of the frequency and quantity of F/V intake. Results Participants had a mean age of 28.9±6.8 years and were predominantly Hispanic (59%), US-born (60%), never married (41%), unemployed (62%), receiving assistance other than WIC (70%), and food insecure (55%). Half reported a high school education or less. Higher proportions of WFS participants than WIC participants nationwide were represented among demographic groups at increased risk of inadequate F/V intake. WFS participants consumed more fruit (2.7 cups/day) but less vegetables (1.4 cups/day) than did women nationwide (1.1 and 1.4 cups/day, respectively; P <0.01). Although participants consumed recommended amounts of fruit, their vegetable intake was below recommended levels. All but two of the measures developed for the study had reliability coefficients at or above 0.60. Conclusions Intervention is warranted to improve participants’ vegetable intake. Registered dietitian nutritionists should be aware of F/V intake differences that may require differential intervention strategies. [ABSTRACT FROM AUTHOR]

Background: The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo). At the time of the trial's development, NIH had invested substantial resources in evaluating the potential benefits of these antioxidants. To capitalize on the knowledge gained from following a large cohort of healthy, aging males on the effects of selenium and/or vitamin E, ancillary studies with other disease endpoints were solicited.Methods: Four ancillary studies were added. Each drew from the same population but had independent objectives and an endpoint other than prostate cancer. These studies fell into two categories: those prospectively enrolling and following participants (studies of Alzheimer's disease and respiratory function) and those requiring a retrospective medical record review after a reported event (cataracts/age-related macular degeneration and colorectal screening). An examination of the challenges and opportunities of adding ancillary studies is provided. The impact of the ancillary studies on adherence to SELECT was evaluated using a Cox proportional hazards model.Results: While the addition of ancillary studies appears to have improved participant adherence to the primary trial, this did not come without added complexity. Activation of the ancillary studies happened after the SELECT randomizations had begun resulting in accrual problems to some of the studies. Study site participation in the ancillary trials varied greatly and depended on the interest of the study site principal investigator. Procedures for each were integrated into the primary trial and all monitoring was done by the SELECT Data and Safety Monitoring Committee. The impact of the early closure of the primary trial was different for each of the ancillary trials.Conclusions: The ancillary studies allowed study sites to broaden the research opportunities for their participants. Their implementation was efficient because of the established infrastructure of the primary trial. Implementation of these ancillary trials took substantial planning and coordination but enriched the overall primary trial.Trial Registration: NCT00006392-S0000 : Selenium and Vitamin E in Preventing Prostate Cancer (SELECT) (4 October 2000). NCT00780689-S0000A :  Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) (25 June 2002). NCT00784225-S0000B : Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000 (SEE) (31 October 2008). NCT00706121-S0000D : Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 (ACP) (26 June 2008). NCT00063453-S0000C : Vitamin E and/or Selenium in Preventing Loss of Lung Function in Older Men Enrolled on SELECT Clinical Trial SWOG-S0000 (26 June 2003). [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy and safety of scheduled low-dose haloperidol versus placebo for the prevention of delirium (Intensive Care Delirium Screening Checklist ≥ 4) administered to critically ill adults with subsyndromal delirium (Intensive Care Delirium Screening Checklist = 1-3).Design: Randomized, double-blind, placebo-controlled trial.Setting: Three 10-bed ICUs (two medical and one surgical) at an academic medical center in the United States.Patients: Sixty-eight mechanically ventilated patients with subsyndromal delirium without complicating neurologic conditions, cardiac surgery, or requiring deep sedation.Interventions: Patients were randomly assigned to receive IV haloperidol 1 mg or placebo every 6 hours until delirium occurred (Intensive Care Delirium Screening Checklist ≥ 4 with psychiatric confirmation), 10 days of therapy had elapsed, or ICU discharge.Measurements and Main Results: Baseline characteristics were similar between the haloperidol (n = 34) and placebo (n = 34) groups. A similar number of patients given haloperidol (12/34 [35%]) and placebo (8/34 [23%]) developed delirium (p = 0.29). Haloperidol use reduced the hours per study day spent agitated (Sedation Agitation Scale ≥ 5) (p = 0.008), but it did not influence the proportion of 12-hour ICU shifts patients spent alive without coma (Sedation Agitation Scale ≤ 2) or delirium (p = 0.36), the time to first delirium occurrence (p = 0.22), nor delirium duration (p = 0.26). Days of mechanical ventilation (p = 0.80), ICU mortality (p = 0.55), and ICU patient disposition (p = 0.22) were similar in the two groups. The proportion of patients who developed corrected QT-interval prolongation (p = 0.16), extrapyramidal symptoms (p = 0.31), excessive sedation (p = 0.31), or new-onset hypotension (p = 1.0) that resulted in study drug discontinuation was comparable between the two groups.Conclusions: Low-dose scheduled haloperidol, initiated early in the ICU stay, does not prevent delirium and has little therapeutic advantage in mechanically ventilated, critically ill adults with subsyndromal delirium. [ABSTRACT FROM AUTHOR]

Background: Acute pharyngitis accounts for an estimated 15 million patient visits in the United States. However, there is no proven effective and safe treatment. Although Chinese herbal medicine is widely used in the treatment of acute pharyngitis, there is a lack of evidence-based data. Despite several clinical trials conducted in this setting, no randomized placebo-controlled trial has been performed to date. This trial aims to investigate the efficacy and safety of Qi-Wei-Qing-Yan aerosol (QWQYA), a Chinese herbal prescription, compared with a placebo aerosol in the treatment of acute pharyngitis with lung-stomach excess-heat syndrome.Methods/design: This is a prospective, multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial. A total of 420 adult patients, of either sex, with acute pharyngitis will be enrolled from seven study sites across China. All patients will be randomly allocated to one of three parallel treatment groups: (1) QWQYA with the current propellant, (2) QWQYA with a previous propellant, and (3) the placebo aerosol with the current propellant. The study medication will be administered into the pharyngeal region in three sprays thrice daily for 5 consecutive days. The primary outcome measures are time to complete resolution of sore throat and relief rate of sore throat. Secondary outcome measures include resolution rate of sore throat, time to relief of sore throat, intensity of sore throat, and change of traditional Chinese medicine syndrome score and clinical signs score from baseline to post-treatment, as well as the occurrence of any adverse events.Discussion: This will be the first clinical trial to investigate the efficacy and safety of QWQYA in the treatment of acute pharyngitis in an adult population in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it establish the basis for the efficacy and safety of QWQYA in treating acute pharyngitis, but it might also provide evidence to support the use of Chinese herbal medicine in treating acute pharyngitis and thus support an alternative treatment option for management of acute pharyngitis.Trial Registration: Chinese Clinical Trial Registry ChiCTR-IPR-15005991. [ABSTRACT FROM AUTHOR]

Background Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women's Health Initiative Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention. Objective To evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depression symptoms, cognitive functioning, and sleep quality. Design This randomized controlled trial was analyzed as intent to treat. Participants Between 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline ≥32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type 1 diabetes, or medical conditions with predicted survival <3 years. Intervention Goals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings, and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter. Main outcome measures The RAND 36-Item Health Survey was used to assess HRQoL at baseline, Year 1, and close-out (about 8 years postrandomization), and estimate differential HRQoL subscale change scores. Statistical analyses performed Mean change in HRQoL scores (Year 1 minus baseline) were compared by randomization group using linear models. Results At 1 year, there was a differential change between intervention and comparison group of 1.7 units (95% CI 1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (95% CI 1.7, 2.3), vitality by 1.9 units (95% CI 1.6, 2.2), and global quality of life by 0.09 units (95% CI 0.07, 0.12). With the exception of global quality of life, these effects were significantly modified by body mass index at baseline. Conclusions DM intervention was associated with small, but significant improvements in three HRQoL subscales: general health, physical functioning, and vitality at 1 year follow-up, with the largest improvements seen in the women with the greatest baseline body mass index. [ABSTRACT FROM AUTHOR]

Background: Early in medical education, physicians must develop competencies needed for tobacco dependence treatment.Objective: To assess the effect of a multi-modal tobacco dependence treatment curriculum on medical students' counseling skills.Design: A group-randomized controlled trial (2010-2014) included ten U.S. medical schools that were randomized to receive either multi-modal tobacco treatment education (MME) or traditional tobacco treatment education (TE).Setting/participants: Students from the classes of 2012 and 2014 at ten medical schools participated. Students from the class of 2012 (N = 1345) completed objective structured clinical examinations (OSCEs), and 50 % (N = 660) were randomly selected for pre-intervention evaluation. A total of 72.9 % of eligible students (N = 1096) from the class of 2014 completed an OSCE and 69.7 % (N = 1047) completed pre and post surveys.Interventions: The MME included a Web-based course, a role-play classroom demonstration, and a clerkship booster session. Clerkship preceptors in MME schools participated in an academic detailing module and were encouraged to be role models for third-year students.Measurements: The primary outcome was student tobacco treatment skills using the 5As measured by an objective structured clinical examination (OSCE) scored on a 33-item behavior checklist. Secondary outcomes were student self-reported skills for performing 5As and pharmacotherapy counseling.Results: Although the difference was not statistically significant, MME students completed more tobacco counseling behaviors on the OSCE checklist (mean 8.7 [SE 0.6] vs. mean 8.0 [SE 0.6], p = 0.52) than TE students. Several of the individual Assist and Arrange items were significantly more likely to have been completed by MME students, including suggesting behavioral strategies (11.8 % vs. 4.5 %, p < 0.001) and providing information regarding quitline (21.0 % vs. 3.8 %, p < 0.001). MME students reported higher self-efficacy for Assist, Arrange, and Pharmacotherapy counseling items (ps ≤0.05).Limitations: Inclusion of only ten schools limits generalizability.Conclusions: Subsequent interventions should incorporate lessons learned from this first randomized controlled trial of a multi-modal longitudinal tobacco treatment curriculum in multiple U.S. medical schools. NIH Trial Registry Number: NCT01905618. [ABSTRACT FROM AUTHOR]

Background: The efficacy of cognitive behavioral therapy (CBT) for the treatment of depressive disorders has been demonstrated in many randomized controlled trials (RCTs). This study investigated whether for CBT similar effects can be expected under routine care conditions when the patients are comparable to those examined in RCTs.Method: N=574 CBT patients from an outpatient clinic were stepwise matched to the patients undergoing CBT in the National Institute of Mental Health Treatment of Depression Collaborative Research Program (TDCRP). First, the exclusion criteria of the RCT were applied to the naturalistic sample of the outpatient clinic. Second, propensity score matching (PSM) was used to adjust the remaining naturalistic sample on the basis of baseline covariate distributions. Matched samples were then compared regarding treatment effects using effect sizes, average treatment effect on the treated (ATT) and recovery rates.Results: CBT in the adjusted naturalistic subsample was as effective as in the RCT. However, treatments lasted significantly longer under routine care conditions.Limitations: The samples included only a limited amount of common predictor variables and stemmed from different countries. There might be additional covariates, which could potentially further improve the matching between the samples.Conclusions: CBT for depression in clinical practice might be equally effective as manual-based treatments in RCTs when they are applied to comparable patients. The fact that similar effects under routine conditions were reached with more sessions, however, points to the potential to optimize treatments in clinical practice with respect to their efficiency. [ABSTRACT FROM AUTHOR]

Background: Fruit and vegetable (FV) based intervention studies can be effective in increasing short term FV consumption. However, the longer term efficacy of such interventions is still unclear. The aim of the current study was to examine the maintenance of change in FV consumption 18-months after cessation of a FV intervention and to examine the effect of participating in a FV intervention on barriers to FV consumption. Methods: A follow-up of a randomised controlled FV trial in 83 older adults (habitually consuming ≤2 portions/ day) was conducted. At baseline, participants were assigned to continue consuming ≤2 portions FV/day or consume ≥5 portions FV/day for 16-weeks. We assessed FV intake and barriers to FV consumption at baseline, end of intervention and 18-months post-intervention. Results: At 18-months, mean FV intakes in both groups were greater than baseline. The 5 portions/day group continued to show greater increases in FV consumption at 18-months than the 2 portions/day group (p < 0.01). At 18-months, both groups reported greater liking (p<0.01) and ease in consuming FV (p = 0.001) while difficulties with consuming FV decreased (p < 0.001). The 2 portions/day group reported greater awareness of FV recommendations at 18-months (p< 0.001). Conclusions: Participating in a FV intervention can lead to longer-term positive changes in FV consumption regardless of original group allocation. Trial registration: Clinical Trials.gov NCT00858728. [ABSTRACT FROM AUTHOR]

Aim. The aim of this study was to report a study protocol that examines feasibility, preliminary efficacy and satisfaction of a text message intervention on the outcome of medication adherence in adult patients prescribed oral anti-cancer agents. Background. Administration of oral anti-cancer agents occurs in the home setting, requiring patients to self-manage the regimen as prescribed. However, many barriers to medication adherence exist: regimens are often complex, with cycling of two or more medications; side effects of treatment; most cancer patients are older with comorbid conditions and competing demands; and cognitive decline and forgetfulness may occur. Research indicates patients miss nearly one-third of the prescribed oral anti-cancer agent dosages. Text message interventions have been shown to improve medication adherence in chronic conditions other than cancer. However, a majority of those patients were less than 50 years of age and most cancer patients are diagnosed later in life. Design. A two-group randomized controlled trial with repeated measures. Methods. Seventy-five adult patients newly prescribed an oral anti-cancer agent will be recruited (project funded in April 2013) from community cancer centres and a specialty pharmacy. Participants will be randomized to either a control group (n = 25; usual care) or an intervention group (n = 50; usual care plus text messages timed to medication regimen). Outcome measures include: medication adherence, feasibility and satisfaction with the intervention. Data will be collected over 8 weeks: baseline, weekly and exit. Discussion. Standardized text message intervention protocol and detailed study procedures have been developed in this study to improve medication adherence. [ABSTRACT FROM AUTHOR]

Health communication campaigns often seek to diminish stigma and promote care seeking, with public service announcements (PSAs) frequently prominent in these campaigns. One example is the Australian-based beyondblue campaign. As an alternative approach, campaigns may seek to reduce stigma by promoting stories of recovery. Participants completed measures of stigmatizing and empowering attitudes at pre-, post-, and 72-hour follow-up after being randomized to a PSA recovery-oriented video, treatable disease-oriented video (beyondblue), or control. When exposed to the recovery-oriented PSA, participants showed significant reduction in stigmatizing attitudes from pre- to posttest than beyondblue or the control group with the emergence of nonsignificant trends identified at follow-up. Findings suggest a recovery-oriented video leads to better change on measures of stigma and affirming attitudes than beyondblue. Despite the aforementioned findings, results failed to show either the recovery or beyondblue videos had a significant impact on intent to seek treatment. [ABSTRACT FROM AUTHOR]

One of the largest disparities in cancer mortality in the United States occurs with colorectal cancer (CRC). The objectives of this multilevel two-arm intervention trial were to compare the efficacy of two interventions to promote CRC screening (CRCS) with fecal immunochemical test (FIT) and examine sociodemographic and psychosocial predictors of FIT screening. Individuals ages 50-75 (n = 326) who were not up-to-date with CRCS, could understand English or Spanish, and were at average CRC risk were recruited from two federally qualified health centers (FQHCs) in Florida. Prior to intervention, CRCS rates in the FQHCs were 27.1% and 32.9%, respectively. Study enrollment occurred April 2018-November 2019. System-level intervention components included leveraging electronic medical record (EMR) systems and delivering patient reminders. Participants were randomized to C-CARES (education+FIT) or C-CARES Plus (C-CARES+personalized coaching [for those not completing FIT within 90 days]). Primary outcome was completed FIT returned <1 year. Primary outcome analyses were performed using logistic regression. 225 participants completed FIT (69.0% [95% CI: 64.0-74.0%]), with no significant difference in FIT uptake by intervention arm (67.3% C-CARES Plus vs. 70.8% C-CARES; p = .49). FIT uptake was significantly higher among patients who received intervention materials in Spanish (77.2%) compared to those who received materials in English (63.2%, p < .01). The personalized coaching in the C-CARES Plus arm did not appear to provide added benefit beyond the C-CARES intervention. Multilevel approaches that include EMR prompts, reminders, FIT access, and provision of low-literacy, language-concordant education can support efforts to improved community clinics' CRCS rates. Future efforts should focus on repeat FIT screening. Trial registration: The trial was registered at ClinicalTrials.gov (NCT03906110). [ABSTRACT FROM AUTHOR]

OBJECTIVE: To measure the effects of participating in structured oral presentation evaluation sessions early in pediatric clerkships on students' subsequent presentations. METHODS: We conducted a single-blind, 3-arm, cluster randomized controlled trial during pediatric clerkships at Boston University School of Medicine, University of Maryland School of Medicine, Oregon Health & Science University, and Case Western Reserve University School of Medicine. Blocks of students at each school were randomly assigned to experience either (1) no formal presentation feedback (control) or a small-group presentation feedback session early in pediatric clerkships in which students gave live presentations and received feedback from faculty who rated their presentations by using a (2) single-item (simple) or (3) 18-item (detailed) evaluation form. At the clerkship end, overall quality of subjects' presentations was rated by faculty blinded to randomization status, and subjects reported whether their presentations had improved. Analyses included multivariable linear and logistic regressions clustered on clerkship block that controlled for medical school. RESULTS: A total of 476 participants were evenly divided into the 3 arms, which had similar characteristics. Compared with controls, presentation quality was significantly associated with participating in detailed (coefficient: 0.38; 95% confidence interval [Cl]: 0.07-0.69) but not simple (coefficient: 0.16; 95% Cl: —0.12-0.43) feedback sessions. Similarly, student self-report of presentation improvement was significantly associated with participating in detailed (odds ratio: 2.16; 95% Cl: 1.11-4.18] but not simple (odds ratio: 1.89; 95% Cl: 0.91-3.93) feedback sessions. CONCLUSIONS: Small-group presentation feedback sessions led by faculty using a detailed evaluation form resulted in clerkship students delivering oral presentations of higher quality compared with controls. [ABSTRACT FROM AUTHOR]

Background Major depressive disorder is highly prevalent among Latinos with limited English language proficiency in the United States. Although major depressive disorder is highly treatable, barriers to depression treatment have historically prevented Latinos with limited English language proficiency from accessing effective interventions. The project seeks to evaluate the efficacy of behavioral activation treatment for depression, an empirically supported treatment for depression, as an intervention that may address some of the disparities surrounding the receipt of efficacious mental health care for this population. Methods/design Following a pilot study of behavioral activation treatment for depression with 10 participants which yielded very promising results, the current study is a randomized control trial testing behavioral activation treatment for depression versus a supportive counseling treatment for depression. We are in the process of recruiting 60 Latinos with limited English language proficiency meeting criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders 4th and 5th Edition for participation in a single-center efficacy trial. Participants are randomized to receive 10 sessions of behavioral activation treatment for depression (n = 30) or 10 sessions of supportive counseling (n = 30). Assessments occur prior to each session and at 1 month after completing treatment. Intervention targets include depressive symptomatology and the proposed mechanisms of behavioral activation treatment for depression: activity level and environmental reward. We will also examine other factors related to treatment outcome such as treatment adherence, treatment satisfaction, and therapeutic alliance. Discussion This randomized controlled trial will allow us to determine the efficacy of behavioral activation treatment for depression in a fast-growing, yet highly underserved population in US mental health services. The study is also among the first to examine the effect of the proposed mechanisms of change of behavioral activation treatment for depression (that is, activity level and environmental reward) on depression over time. To our knowledge, this is the first randomized controlled trial to compare an empirical-supported treatment to a control supportive counseling condition in a sample of depressed, Spanish-speaking Latinos in the United States. [ABSTRACT FROM AUTHOR]

Objective A single-agent, extended-release formulation of hydrocodone (HC) has been developed for treatment of chronic moderate-to-severe pain. This study was designed to examine the safety and efficacy of HC extended release in opioid-experienced adults with moderate-to-severe chronic low back pain (CLBP). Methods This multicenter, enriched enrollment, randomized withdrawal study comprised an open-label conversion/titration phase (≤6 weeks) followed by placebo-controlled, double-blind treatment (12 weeks). During the conversion/titration phase, subjects (N = 510) converted from their current opioid and were titrated to a stabilized dose of HC extended release (20−100 mg every 12 hours). During treatment, subjects (N = 151 per group) received HC extended release or placebo; rescue medication was permitted. The primary efficacy end point was mean change in average pain intensity from baseline to day 85. Response rates (30% pain improvement) and satisfaction ( Subject Global Assessment of Medication) were assessed. Results Demographic and baseline characteristics were similar between groups. Mean ± SD change in average pain intensity score from baseline to day 85 was significantly lower in the HC extended-release treatment group vs placebo (0.48 ± 1.56 vs 0.96 ± 1.55; P = 0.008). Significantly more responders were in the treatment group (68% vs 31%; P < 0.001). Mean Subject Global Assessment of Medication scores increased significantly (0.8 ± 1.3 vs 0.0 ± 1.4; P < 0.0001), indicating greater satisfaction with HC extended release. The adverse event profile was consistent with other opioids. Conclusions Extended-release HC is well tolerated and effective, without acetaminophen-associated risks of liver toxicity, for treatment of CLBP. [ABSTRACT FROM AUTHOR]

Objectives To better understand the effectiveness of xylitol in caries prevention in adults and to attempt improved clinical trial efficiency. Methods As part of the Xylitol for Adult Caries Trial (X- ACT), non cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 g/day of xylitol, consumed by dissolving in the mouth five 1 g lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21-80, with complete data for four dental examinations, were selected from the 691 randomized into the 3-year trial, conducted at three sites. Acceptable inter- and intra-examiner reliability before and during the trial was quantified using the kappa statistic. Results The mean annualized noncavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically nonsignificant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit. Conclusions There was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non cavitated plus cavitated lesions were assessed. This conformed to the X- ACT trial result assessing cavitated lesions. Including non cavitated lesion assessment in this full-scale, placebo-controlled, multisite, randomized, double-blinded clinical trial in adults experiencing dental caries did not achieve added trial efficiency or demonstrate practical benefit of xylitol. Trial Registration: ClinicalTrials.Gov NCT00393055. [ABSTRACT FROM AUTHOR]

Abstract: High consumption of sugar-sweetened beverages (SSB) contributes to a wide range of poor health outcomes. Further, few US adults drink less than the recommended ≤8oz per day; and individuals with low socioeconomic, low health literacy status, and in rural areas are even less likely to meet recommendations. Unfortunately, few SSB behavioral interventions exist targeting adults, and none focus on low health literacy in rural areas. Talking Health, a type 1 effectiveness-implementation hybrid trial targeting adults in rural southwest Virginia, was developed using the RE-AIM planning and evaluation framework (reach, effectiveness, adoption, implementation, maintenance). The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore). SIPsmartER was developed based upon the Theory of Planned Behavior and uses health literacy strategies to improve comprehension of the intervention content among participants. MoveMore is based on a research-tested intervention that was adapted to address all theory of planned behavior constructs and health literacy principles. Secondary aims include additional health outcomes (e.g., physical activity, weight) and reach, adoption, implementation, and maintenance indicators. This paper highlights the opportunities and considerations for developing health behavior trials that aim to determine intervention effectiveness, provide all study participants an opportunity to benefit from research participation, and collect key information on reach and the potential for organizational adoption, implementation, and maintenance with the longer-term goal of speeding translation into practice settings. [Copyright &y& Elsevier]

Aim To test whether titanium-zirconium (TiZr) 3.3 mm diameter implants perform differently from titanium (Ti) 4.1 mm diameter implants with respect to marginal bone level (MBL) and clinical parameters. Material and Methods Forty subjects in need of a single implant-supported crown in the anterior or premolar regions were recruited in two centres. After random allocation, either a Ti or a TiZr implant was placed. Definitive crowns were inserted 6 months after implant placement. Implant survival, change in MBL, clinical parameters and occurrence of adverse events were assessed at the 1-year examination. Results At 1 year, 38 of the 40 included patients were examined (18 Ti and 20 TiZr implants). All the implants were in place and stable. From the implant placement to the 1-year examination, the change of MBL amounted to −0.40 mm in the Ti group and −0.41 mm in the TiZr group. There were no significant differences between the groups regarding the change in MBL, the clinical parameters and the occurrence of adverse events. Conclusions The use of TiZr implants with narrow diameter for the support of single crowns in the anterior and premolar regions leads to successful tissue integration and clinical performance over a 1-year period. [ABSTRACT FROM AUTHOR]

Background There is continued debate on the effectiveness, indications, and medical necessity of epidural injections in managing pain and disability from lumbar disc herniation, despite extensive utilization. There is paucity of literature on interlaminar epidural injections in managing lumbar disc herniation or radiculitis in contemporary interventional pain management settings utilizing fluoroscopy. Methods A randomized, double-blind, active-control trial was undertaken to assess the effectiveness of lumbar interlaminar epidural injections with or without steroids for disc herniation and radiculitis. The primary outcome was defined as pain relief and functional status improvement of ≥ 50%. One hundred twenty patients were randomly assigned to 1 of the 2 groups. Group I patients received lumbar interlaminar injections containing a local anesthetic (lidocaine 0.5%, 6 mL), whereas Group II patients received lumbar interlaminar epidural injections of 0.5% lidocaine, 5 mL, mixed with 1 mL of non-particulate betamethasone. Results In the patients who responded with initial 2 procedures with at least 3 weeks of relief, significant improvement was seen in 80% of the patients in the local anesthetic group and 86% of the patients in the local anesthetic and steroid group. The overall average procedures per year were 3.6 in the local anesthetic group and 4.1 in the local anesthetic and steroid group, with an average relief of 33.7 ± 18.1 weeks in the local anesthetic group and 39.1 ± 12.2 weeks in the local anesthetic and steroid group over a period of 52 weeks in the overall population. Conclusions Lumbar interlaminar epidural injections of local anesthetic with or without steroids might be effective in patients with disc herniation or radiculitis, with potential superiority of steroids compared with local anesthetic alone at 1 year follow-up. [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]

The article discusses a randomized controlled single-blinded trial testing a computer-assisted cognitive rehabilitation intervention, MAPSS-MS (Memory, Attention, and Problem Solving Skills for persons with Multiple Sclerosis), to help individuals acquire the highest level of cognitive functioning and functional independence. The results showed that MAPSS-MS group had greater improvements than the control group on four of the seven neuropsychological tests involved.

OBJECTIVE: Leverage an experimental study to determine whether gender or recent crime victimization modify the mental health effects of moving to low-poverty neighborhoods. METHODS: The Moving to Opportunity (MTO) study randomized low- income families in public housing to an intervention arm receiving vouchers to subsidize rental housing in lower-poverty neighborhoods or to controls receiving no voucher. We examined 3 outcomes 4 to 7 years after randomization, among youth aged 5 to 16 years at baseline (n = 2829): lifetime major depressive disorder (MDD), psychological distress (K6), and Behavior Problems Index (BPI). Treatment effect modification by gender and family's baseline report of recent violent crime victimization was tested via interactions in covariate-adjusted intent-to-treat and instrumental variable adherence- adjusted regression models. RESULTS: Gender and crime victimization significantly modified treatment effects on distress and BPI (P < .10). Female adolescents in families without crime victimization benefited from MTO treatment, for all outcomes (Distress B = -0.19, P= .008; BPI B = -0.13, P= .06; MDD B = -0.036, P= .03). Male adolescents in intervention families experiencing crime victimization had worse distress (B = 0.24, P = .004), more behavior problems (B = 0.30, P < .001), and nonsignificantly higher MDD (B = 0.022, P= .16) versus controls. Other subgroups experienced no effect of MTO treatment. Instrumental variable estimates were similar but larger. CONCLUSIONS: Girls from families experiencing recent violent crime victimization were significantly less likely to achieve mental health benefits, and boys were harmed, by MTO, suggesting need for cross- sectoral program supports to offset multiple Stressors. [ABSTRACT FROM AUTHOR]

Abstract: Depression affects 20–30% of people living with HIV/AIDS (PLWHA) in the U.S. and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV adherence and clinical outcomes in PLWHA with depression. The Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB, and UNC (SLAM DUNC) Study is a randomized clinical effectiveness trial funded by the National Institute for Mental Health. The objective of SLAM DUNC is to test whether a depression treatment program integrated into routine HIV clinical care affects ARV adherence. PLWHA with depression (n=390) are randomized to enhanced usual care or a depression treatment model called Measurement-Based Care (MBC). MBC deploys a clinically supervised Depression Care Manager (DCM) to provide evidence-based antidepressant treatment recommendations to a non-psychiatric prescribing provider, guided by systematic and ongoing measures of depressive symptoms and side effects. MBC has limited time requirements and the DCM role can be effectively filled by a range of personnel given appropriate training and supervision, enhancing replicability. In SLAM DUNC, MBC is integrated into HIV care to support HIV providers in antidepressant prescription and management. The primary endpoint is ARV adherence measured by unannounced telephone-based pill counts at 6months with follow-up to 12months and secondary endpoints including viral load, health care utilization, and depressive severity. Important outcomes of this study will be evidence of the effectiveness of MBC in treating depression in PLWHA and improving HIV-related outcomes. [Copyright &y& Elsevier]

Objective To compare the treatment outcome of scaling and root planing ( SRP) in combination with systemic antibiotics, local antibiotic therapy and/or periodontal surgery. Material and Methods One hundred and eighty-seven patients were assigned to eight groups treated by SRP plus none, one, two or three adjunctive treatments and monitored for 24 months in a randomized controlled clinical trial using a 2 × 2 × 2 factorial design. Systemic amoxicillin + metronidazole ( SMA), local tetracycline delivery ( LTC) and periodontal surgery (SURG) were evaluated as adjuncts. Changes in clinical attachment level ( CAL) and probing pocket depth ( PPD) were statistically evaluated by ancova of main effects. Results Effects of adjunctive therapy to SRP were minimal at 3 months. Between 3 and 6 months PPD reduction occurred particularly in patients receiving periodontal surgery. After 6 months, both CAL gain and PPD reduction reached a plateau that was maintained at 24 months in all groups. The 24-month CAL gain was improved by SMA (0.50 mm) while PPD was reduced by SMA (0.51 mm) and SURG (0.36 mm). Smoking reduced CAL gain and PPD reduction. Conclusion Patients receiving adjunctive therapies generally exhibited improved CAL gain and/or PPD reduction when compared with the outcome of SRP alone. Only additive, not synergistic effects of the various adjunctive therapies were observed. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims This study evaluated the effectiveness of a brief intervention (BI) for illicit drugs (cannabis, cocaine, amphetamine-type stimulants and opioids) linked to the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The ASSIST screens for problem or risky use of 10 psychoactive substances, producing a score for each substance that falls into either a low-, moderate- or high-risk category. Design Prospective, randomized controlled trial in which participants were either assigned to a 3-month waiting-list control condition or received brief motivational counselling lasting an average of 13.8 minutes for the drug receiving the highest ASSIST score. Setting Primary health-care settings in four countries: Australia, Brazil, India and the United States. Participants A total of 731 males and females scoring within the moderate-risk range of the ASSIST for cannabis, cocaine, amphetamine-type stimulants or opioids. Measurements ASSIST-specific substance involvement scores for cannabis, stimulants or opioids and ASSIST total illicit substance involvement score at baseline and 3 months post-randomization. Findings Omnibus analyses indicated that those receiving the BI had significantly reduced scores for all measures, compared with control participants. Country-specific analyses showed that, with the exception of the site in the United States, BI participants had significantly lower ASSIST total illicit substance involvement scores at follow-up compared with the control participants. The sites in India and Brazil demonstrated a very strong brief intervention effect for cannabis scores ( P < 0.005 for both sites), as did the sites in Australia ( P < 0.005) and Brazil ( P < 0.01) for stimulant scores and the Indian site for opioid scores ( P < 0.01). Conclusions The Alcohol, Smoking and Substance Involvement Screening Test-linked brief intervention aimed at reducing illicit substance use and related risks is effective, at least in the short term, and the effect generalizes across countries. [ABSTRACT FROM AUTHOR]