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Background: Tinnitus is a symptom that can be very distressing owing to hearing sounds not related to any external sound source. Managing tinnitus is notoriously difficult, and access to evidence-based care is limited. Cognitive behavioral therapy (CBT) is a tinnitus management strategy with the most evidence of effectiveness but is rarely offered to those distressed by tinnitus. The provision of internet-based CBT for tinnitus overcomes accessibility barriers; however, it is not currently readily available in the United States.Objective: The aim of this study is to investigate the efficacy of internet-based CBT compared with that of weekly monitoring for the management of tinnitus in reducing tinnitus distress; reducing tinnitus-related comorbidities, including tinnitus cognitions, insomnia, anxiety, and depression; and assessing the stability of the intervention effects 2 months after the intervention.Methods: A 2-arm randomized clinical trial comparing audiologist-guided internet-based CBT (n=79) to a weekly monitoring group (n=79) with a 2-month follow-up assessed the efficacy of internet-based CBT. Eligible participants included adults seeking help for tinnitus. Recruitment was conducted on the web using an open-access website. Participants were randomized via 1:1 allocation, but blinding was not possible. The study was undertaken by English or Spanish speakers on the web. The primary outcome was a change in tinnitus distress as measured using the Tinnitus Functional Index. Secondary outcome measures included anxiety, depression, insomnia, tinnitus cognition, hearing-related difficulties, and quality of life.Results: Internet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean 46.31, SD 20.63; effect size: Cohen d=0.46, 95% CI 0.14-0.77) using an intention-to-treat analysis. For the secondary outcomes, there was a greater reduction in negative tinnitus cognition and insomnia. The results remained stable over the 2-month follow-up period. No important adverse events were observed. Further, 16% (10/158) of participants withdrew, with low overall compliance rates for questionnaire completion of 72.3% (107/148) at T1, 61% (91/148) at T2, and 42% (62/148) at T3.Conclusions: This study is the first to evaluate and indicate the efficacy of audiologist-delivered internet-based CBT in reducing tinnitus distress in a US population. It was also the first study to offer internet-based CBT in Spanish to accommodate the large Hispanic population in the United States. The results have been encouraging, and further work is indicated in view of making such an intervention applicable to a wider population. Further work is required to improve compliance and attract more Spanish speakers.Trial Registration: ClinicalTrials.gov NCT04004260; https://clinicaltrials.gov/ct2/show/NCT04004260. [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]

Objectives: The most common approach to treatment of domestic violence crimes in the United States is the mandated group-based Batterer Intervention Program (BIP). Several alternative treatment approaches have been developed over the years, including a restorative justice-based treatment program for domestic violence offenders called Circles of Peace (CP). This study compared a CP program administered in Arizona with a local BIP program, in controlled settings. Methods: This study involved a randomized controlled trial with 152 domestic violence cases randomly assigned to either BIP or CP between September 2005 and March 2007. Independent sample t tests were used to measure treatment outcomes post-random assignment, in terms of both domestic violence and non-domestic violence re-arrest rates during four follow-up periods (6, 12, 18, and 24 months). Results: CP participants experienced less recidivism than BIP during all follow-up comparisons. However, statistically significant differences were detected only for the 6-month ( p < .1) and the 12-month ( p < .05) follow-up comparisons for non-domestic violence re-arrests, and no statistically significant differences were detected for the domestic violence re-arrests. Conclusions: The findings are generally statistically non-significant at .05. While these results do not suggest a change in policy from BIP to CP for domestic violence crimes, it does dispel the popular belief that restorative justice cannot be used to treat domestic violence criminal activity, in that CP does no worse than the traditional batterer intervention program. Given the low statistical power and high attrition rates, more research is necessary to test CP and restorative justice treatment generally in court-mandated domestic violence cases in order to understand the treatment impact on both domestic violence and non-domestic violence offenders. [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.

Background: There is a growing body of evidence indicating that web-based personalized feedback interventions can reduce the amount of alcohol consumed in problem drinking college students. This study sought to evaluate whether providing voluntary access to such an intervention would have an impact on drinking. Methods: College students responded to an email inviting them to participate in a short drinking survey. Those meeting criteria for risky drinking (and agreeing to participate in a follow-up) were randomized to an intervention condition where they were offered to participate in a web-based personalized feedback intervention or to a control condition (intervention not offered). Participants were followed-up at six weeks. Results: A total of 425 participants were randomized to condition and 68% (n = 290) completed the six-week follow-up. No significant difference in drinking between conditions was observed. Conclusions: Web-based personalized feedback interventions that are offered to students on a voluntary basis may not have a measurable impact on problem drinking. [ABSTRACT FROM AUTHOR]

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]

Abstract: This systematic review aims to evaluate the available evidence from randomized clinical trials of the clinical efficacy and safety of ginseng. Systematic literature searches were performed in 13 databases up to March 2009 without language restriction. All randomized clinical trials evaluating the clinical effects or safety of the use of ginseng monopreparations (Panax ginseng or P. quinquefolium) were considered for inclusion. A total of 411 potentially relevant studies were identified and 57 randomized clinical trials were included. The main indications included glucose metabolism, physical performance, psychomotor function, sexual function, cardiac function, pulmonary disease, and cerebrovascular disease. We found strong evidence of a positive effect of ginseng on glucose metabolism, psychomotor function, and pulmonary disease, whereas evidence suggests that ginseng is not effective at enhancing physical performance. However, ginseng generally has a good safety profile and the incidence of adverse effects seems to be low. In conclusion, our review compiles the evidence on the use of ginseng, finding a strong positive potential for glucose metabolism, psychomotor function, and pulmonary disease, but not for physical performance enhancement. [Copyright &y& Elsevier]

The history of placebos in psychiatry can be understood only in the context of randomized controlled trials (RCTs). Placebo treatments are as old as medicine itself, and are particularly effective in dealing with psychosomatic symptoms. In psychiatry, placebos have mainly been featured in clinical drug trials. The earliest controlled trial in psychiatry (not involving drugs) occurred in 1922, followed by the first crossover studies during the 1930s. Meanwhile the concept of randomization was developed during the interwar years by British statistician Ronald A Fisher, and introduced in 3 trials of tuberculosis drugs between 1947 and 1951. These classic studies established the RCT as the gold standard in pharmaceutical trials, and its status was cemented during the mid-1950s. Nevertheless, while the placebo became established as a standard measure of drug action, placebo treatments became stigmatized as unethical. This is unfortunate, as they constitute one of the most powerful therapies in psychiatry. In recent years, moreover, the dogma of the placebo-controlled trial as the only acceptable data for drug licensing is also being increasingly discredited. This backlash has had 2 sources: one is the recognition that the US Food and Drug Administration has been too lax in permitting trials controlled with placebos alone, rather than also using an active agent as a test of comparative efficacy. In addition, there is evidence that in the hands of the pharmaceutical industry, the scientific integrity of RCTs themselves has been degraded into a marketing device. The once-powerful placebo is thus threatened with extinction. [ABSTRACT FROM AUTHOR]

Abstract: Despite the prevalence of Internet support groups for individuals with mental illnesses little is known about the potential benefits, or harm, of participating in such groups. Therefore, this randomized controlled trial sought to determine the impact of unmoderated, unstructured Internet peer support, similar to what is naturally occurring on the Internet, on the well-being of individuals with psychiatric disabilities. Three hundred individuals resident in the USA diagnosed with a Schizophrenia Spectrum or an Affective Disorder were randomized into one of three conditions: experimental Internet peer support via a listserv, experimental Internet peer support via a bulletin board, or a control condition. Three measurement time points, baseline, 4- and 12 months post-baseline, assessed well-being by examining measures of recovery, quality of life, empowerment, social support, and distress. Time × group interactions in the repeated measures ANOVA showed no differences between conditions on the main outcomes. Post-hoc repeated measures ANOVAs found that those individuals who participated more in Internet peer support reported higher levels of distress than those with less or no participation (p = 0.03). Those who reported more positive experiences with the Internet peer support group also reported higher levels of psychological distress than those reporting less positive experiences (p = 0.01). Study results therefore do not support the hypothesis that participation in an unmoderated, unstructured Internet listserv or bulletin board peer support group for individuals with psychiatric disabilities enhances well-being. Counterintuitive findings demonstrating those who report more positive experiences also experienced higher levels of distress are discussed but we also point to the need for additional research. Future research should explore the various structures, formats, and interventions of Internet support, as well as the content and quality of interactions. Knowledge generated from such research can help to inform policies and guidelines for safely navigating online resources and supports to gain maximum benefit. [Copyright &y& Elsevier]

This article examines the effectiveness of four elementary school math curricula: (a) Investigations in Number, Data, and Space; (b) Math Expressions; (c) Saxon Math; and (d) Scott Foresman-Addison Wesley Mathematics (SFAW). These curricula are distinct from one another and represent many of the diverse approaches used to teach elementary school math in the United States. The results are based on 39 schools that were randomly assigned to use the various curricula at the first-grade level. The results show that average spring first-grade math achievement of Math Expressions and Saxon students was 0.30 SD higher than Investigations students and 0.24 SD higher than SFAW students. These effect sizes mean that an average-performing student's percentile rank in math would be 9 to 12 points higher if the school used Math Expressions or Saxon, instead of Investigations or SFAW. We also conducted correlational analyses that examine whether curriculum-group differences in math instructional time and content coverage account for the differences in curriculum effects and found that a portion of the relative effects is due to differences in content coverage. [ABSTRACT FROM AUTHOR]

As the number of dental-related randomized clinical trials (RCTs) increases, there is a need for literature to help investigators inexperienced in conducting RCTs design and implement studies. This commentary describes four 'lessons learned' or considerations important in the planning and initial implementation of RCTs in dentistry that, to our knowledge, have not been discussed in the general dental literature describing trial techniques. These considerations are a) preparing or securing a thorough systematic review; b) developing a comprehensive set of study documents; c) designing and testing multiple recruitment strategies; and d) employing a run-in period prior to enrollment. Attention to these considerations in the planning phases of a dental RCT can help ensure that the trial is clinically relevant while also maximizing the likelihood that its implementation will be successful. [ABSTRACT FROM AUTHOR]

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT? • The USA, UK and Germany have a strong position in performance of drug and nondrug randomized controlled trials. • Europe's position in the quantitative and qualitative performance in drug randomized controlled trials in particular, and factors that drive the quantitative and qualitative performance of drug randomized controlled trials in Europe, are unknown. WHAT THIS STUDY ADDS • Europe's position in the quantitative and qualitative performance of randomized controlled drug trials lags behind USA. • Factors are identified that are associated with the difference in publication output between countries. • The number of headquarters of pharmaceutical companies in a country, the research expenditures by pharmaceutical companies, as well as health-related R&D expenditures of a country appear to contribute to a relatively high scientific performance in randomized controlled drug trials. AIMS Performance of randomized controlled drug trials (drugRCTs) adds to the scientific output, scientific knowledge, scientific training and up-to-date status of healthcare and may drive economy. The purpose of this study was to benchmark Europe's position on drugRCTs relative to the rest of the world, and to identify factors that may drive this performance. METHODS The number of scientific publications on drugRCTs, indexed in PubMed and Thomson Scientific/Web of Science database over the period 1995–2004, was used as a proxy measure for the quantitative drugRCT output. The international citation impact of these publications was used as a proxy measure for the qualitative drugRCT output. RESULTS Country's origin of 103 211 publications was determined. After adjustment for population size, the number of drugRCT publications from Europe, USA and Australia/Japan was 102, 124 and 44 publications per million inhabitants, respectively. The proportional increase in publication output from 1995 until 2004 was lower in Europe compared with the USA and Australia/Japan (29.1, 40.1 and 63.4%, respectively). The number of citations per publication was 4.9 in Europe, 7.0 in the USA and 3.4 in Australia/Japan. Within Europe, the UK, Germany and Italy produced most publications. Country-specific factors associated with publication output in Europe were the number of pharmaceutical companies with headquarters in a country ( R2 = 0.71, P < 0.001), national R&D expenditures by pharmaceutical companies ( R2 = 0.63, P < 0.001) and health-related R&D expenditures by national governments ( R2 = 0.22, P = 0.052). CONCLUSIONS When adjusted for population size, quantitative and qualitative performance of drugRCTs in Europe lags behind the USA but is ahead of Australia/Japan. Several factors appear to explain the differences, among which are the number of headquarters of pharmaceutical companies in a country, the research expenditures by pharmaceutical companies, as well as health-related R&D expenditures of a country. To enhance and strengthen Europe's position, researchers may strengthen their collaborations with local pharmaceutical companies, and national governments could increase their budgets for medical research funding. [ABSTRACT FROM AUTHOR]

• Study presents a culturally tailored entrepreneurship education program for Native American youth living in communities with economic, education, and behavioral and mental health disparities. • Results show the program reduced substance use and violence toward others. • This strength-based, social determinants approach holds promise to address the most vexing issues facing U.S. youth living in poverty. This study reports the impact of an entrepreneurship education intervention designed and evaluated specifically for its impact on substance use, suicide and violence-related outcomes among Native American adolescents. This randomized controlled trial included N = 394 Native Americans ages 13–16. Participants were randomly assigned 2:1 (n = 267:127) to the Arrowhead Business Group intervention versus a control condition. Logistic mixed effects regression models examined within group and between group differences in trajectory from baseline to 24 months follow-up. Fewer intervention vs. control participants used marijuana at 6-, 12- and 24-months post-intervention (19.6% vs. 28.0%, p = 0.032; 20.4% vs. 31.8%, p = 0.01; and 24.1% vs. 31.4%, p = 0.047). All violence-related measures (suicide attempts, carrying a weapon, missing school because felt unsafe, fighting, and fighting at school) statistically significantly declined between baseline and 24 months for both groups. Positive between group differences favoring intervention participants were observed at 6-months for missing school because felt unsafe, and at 24-months for fighting at school. While alcohol use increased for both groups over time, control participants experienced a two-fold higher increase in binge alcohol use than intervention participants (control: 7.1–16.7% vs. intervention: 8.1–13.0%). This is the first report in the US literature of a youth entrepreneurship intervention designed and evaluated to promote behavioral and mental health outcomes. It shows promise for reducing substance abuse and violence toward self and others, the largest health disparities for Native American youth. [ABSTRACT FROM AUTHOR]

By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population. This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH. This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial. • This is the first large-scale prevention trial for older people living with HIV. • Novel methods employed enhance fidelity to treatment delivery. • Features of this RCT blend efficacy and effectiveness designs. [ABSTRACT FROM AUTHOR]

Background: There is a pressing need to address the unacceptable disparities and underrepresentation of racial and ethnic minority groups, including Hispanics or Latinxs, in smoking cessation trials.Objective: Given the lack of research on recruitment strategies for this population, this study aims to assess effective recruitment methods based on enrollment and cost.Methods: Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417). The effectiveness of each recruitment strategy was evaluated by computing the cost per participant (CPP), which is the ratio of direct cost over the number enrolled. More effective strategies yielded lower CPPs. Demographic and smoking-related characteristics of participants recruited via the two most effective strategies were also compared (n=1307).Results: Facebook was the most effective method (CPP=US $74.12), followed by TV advertisements (CPP=US $191.31), whereas public bus interior card advertising was the least effective method (CPP=US $642.50). Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001). Among the participants recruited via Facebook, a greater percentage of individuals had at least a high school education (P<.001) and an annual income above US $10,000 (P<.001). In addition, a greater percentage of individuals were employed (P<.001) and foreign born (P=.003). In terms of subethnicity, among the subjects recruited via Facebook, a lower percentage of individuals were of Mexican origin (P<.001) and a greater percentage of individuals were of Central American (P=.02), South American (P=.01), and Cuban (P<.001) origin.Conclusions: Facebook was the most effective method for recruiting Hispanic or Latinx smokers in the United States for this RCT. However, using multiple methods was necessary to recruit a more diverse sample of Spanish-preferring Hispanic or Latinx smokers. [ABSTRACT FROM AUTHOR]

Objective: To determine whether antioxidants improve male fertility, as measured by semen parameters and DNA fragmentation at 3 months and pregnancy resulting in live birth after up to 6 months of treatment, among couples with male factor infertility.Design: Multicenter, double-blind, randomized, placebo-controlled trial with an internal pilot study.Setting: Nine fertility centers in the United States from December 2015 to December 2018.Patient(s): Men (N = 174) with sperm concentration ≤15 million/mL, motility ≤40%, normal morphology ≤4%, or DNA fragmentation >25%, and female partners who were ovulatory, ≤40 years old, and had documented tubal patency.Intervention(s): Males randomly assigned to receive an antioxidant formulation (n = 85) containing 500 mg of vitamin C, 400 mg of vitamin E, 0.20 mg of selenium, 1,000 mg of l-carnitine, 20 mg of zinc, 1,000 μg of folic acid, 10 mg of lycopene daily, or placebo (n = 86). Treatment lasted for a minimum of 3 months and maximum of 6 months, and couples attempted to conceive naturally during the first 3 months and with clomiphene citrate with intrauterine insemination of the female partner in months 4 through 6.Main Outcome Measure(s): Primary outcome was live birth; secondary outcomes included pregnancy within 6 months of treatment. For the internal pilot, the primary outcomes were semen parameters and sperm DNA fragmentation index after 3 months of treatment.Result(s): In the Males, Antioxidants, and Infertility (MOXI) study, after 3 months of treatment, the change in sperm concentration differed between the antioxidant group (median -4.0 [interquartile range-12.0, 5.7] million/mL) and placebo group (+2.4 [-9.0, 15.5] million/mL). However, there were no statistically significant differences between the two groups for changes in sperm morphology, motility, or DNA fragmentation. Among the 66 oligospermic men at randomization, sperm concentration did not differ at 3 months between the antioxidant and control groups: 8.5 (4.8, 15.0) million/mL versus 15.0 (6.0, 24.0) million/mL. Of the 75 asthenospermic men, motility did not differ at 3 months: 34% ± 16.3% versus 36.4% ± 15.8%. Among the 44 men with high DNA fragmentation, DNA fragmentation did not differ at 3 months: 29.5% (21.6%, 36.5%) versus 28.0% (20.6%, 36.4%). In the entire cohort, cumulative live birth did not differ at 6 months between the antioxidant and placebo groups: 15% versus 24%.Conclusion(s): Antioxidants do not improve semen parameters or DNA integrity among men with male factor infertility. Although limited by sample size, this study suggests that antioxidant treatment of the male partner does not improve in vivo pregnancy or live-birth rates.Clinical Trial Registration Number: NCT02421887. [ABSTRACT FROM AUTHOR]

Many adults in the U.S. do not receive recommended vaccines, and the research literature remains inconclusive on the best communication strategies for increasing this behavior. This study examined the association of message framing (gained-framed vs. loss-framed vs. control), and healthcare provider (HCP) recommendation (offered vs. recommended) on uptake of adult hepatitis B virus (HBV) vaccination in a high risk population using a 3 × 2 block design randomized controlled trial. Fear of shots, fear of vaccines, and perceived message framing were examined in secondary analyses. Of the 1747 participants, 47.7% (n = 833) received 0 doses of HBV vaccine, 27.8% (n = 485) received 1 dose, 10.4% received 2 doses, and 14.1% received all 3 recommended doses. There was not a significant interaction between message framing and HCP recommendation (p = .59). Mean number of doses received by the gain-framed group (m = 0.96) was not significantly different from the loss-framed group (m = 0.97, RR = 0.99, 95% CI = 0.88-1.12). However, those receiving any framing message received significantly more doses (m = 0.96) than those in the control condition (m = 0.81, RR = 1.17, 95%CI = 1.06-1.31). Participants who received a HCP recommendation received significantly more vaccine doses (m = 0.95) than those in the vaccine-offered condition (mean = 0.82, RR = 1.16, 95%CI = 1.05-1.28). These results suggest there is no difference in vaccine uptake between gain-frame and loss-frame messages, but both are better than a control message. These results also support advising HCP to provide a strong recommendation for vaccinations beyond merely offering it to patients. This study has implications for vaccine uptake beyond HBV, and can inform future research on effective vaccine communication research. Clinicaltrials.gov Identifier: NCT00739752. Registration date: August 20, 2008. [ABSTRACT FROM AUTHOR]

Context: Promoting patient value-concordant end-of-life care is a priority in health care systems but has rarely been examined in randomized clinical trials.Objectives: To examine the effectiveness of an advance care planning intervention in facilitating concordance between cancer patients' preferred and received life-sustaining treatment (LST) states and to explore modifiable factors facilitating or impeding such concordance.Methods: Terminal cancer patients (N = 460) were randomly assigned 1:1 to the experimental and control arms of a randomized clinical trial, with 430 deceased participants comprising the final sample. States of preferred LSTs (cardiopulmonary resuscitation, intensive care unit care, chest compression, intubation with mechanical ventilation, intravenous nutrition, and nasogastric tube feeding) and LSTs received in the last month were examined by hidden Markov modeling. Concordance and its modifiable predictors were evaluated by kappa and multivariate logistic regression, respectively.Results: We identified three LST-preference states (uniformly preferring LSTs, rejecting LSTs except intravenous nutrition support, and mixed LST preferences) and three received LST states (uniformly receiving LSTs, received intravenous nutrition only, and selectively receiving LSTs). Concordance was not significantly higher in the experimental than the control arm (kappa [95% CI]: 0.126 [0.032, 0.221] vs. 0.050 [-0.028, 0.128]; arm difference: odds ratio [95% CI]: 1.008 [0.675, 1.5001]). Preferred-received LST-state concordance was facilitated by accurate prognostic awareness, better quality of life, and more depressive symptoms, whereas concordance was impeded by more anxiety symptoms.Conclusions: Our advance care planning intervention did not facilitate concordance between terminally ill cancer patients' preferred and received LST states, but patient value-concordant end-of-life care may be facilitated by interventions to cultivate accurate prognostic awareness, improve quality of life, support depressive patients, and clarify anxious patients' overexpectations of LST efficacy. [ABSTRACT FROM AUTHOR]

Background: Uterine leiomyomas (fibroid tumors) cause considerable symptoms in 30-50% of women and are the leading cause of hysterectomy in the United States. Women with uterine fibroid tumors often seek uterine-preserving treatments, but comparative effectiveness trials are lacking.Objective: The purpose of this study was to report treatment effectiveness and ovarian function after uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study.Study Design: The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study, which is a randomized controlled trial of uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery, enrolled premenopausal women with symptomatic uterine fibroid tumors; women who declined randomization were enrolled in a parallel observational cohort. A comprehensive cohort design was used for outcomes analysis. Our target enrollment was 220 women, of which we achieved 41% (n=91) in the randomized and parallel arms of the trial. Primary outcome was reintervention for uterine fibroid tumors within 36 months. Secondary outcomes were change in serum anti-Müllerian hormone levels and standardized measures of fibroid symptoms, quality of life, pain, and sexual function.Results: From 2010-2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 for magnetic resonance imaging-guided focused ultrasound surgery [27 randomized]; 40 for uterine artery embolization [22 randomized]); baseline clinical and uterine characteristics were similar between treatment arms, except for higher fibroid load in the uterine artery embolization arm. The risk of reintervention was higher with magnetic resonance imaging-guided focused ultrasound surgery than uterine artery embolization (hazard ratio, 2.81; 95% confidence interval, 1.01-7.79). Uterine artery embolization showed a significantly greater absolute decrease in anti-Müllerian hormone levels at 24 months compared with magnetic resonance imaging-guided focused ultrasound surgery. Quality of life and pain scores improved in both arms but to a greater extent in the uterine artery embolization arm. Higher pretreatment anti-Müllerian hormone level and younger age at treatment increased the overall risk of reintervention.Conclusion: Our study demonstrates a lower reintervention rate and greater improvement in symptoms after uterine artery embolization, although some of the effectiveness may come through impairment of ovarian reserve. Both pretreatment anti-Müllerian hormone level and age are associated with risk of reintervention.Clinical Trial Registration Number: NCT00995878, clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Background: Dexmedetomidine (DEX) has sedative, sympatholytic and analgesic effects and might be beneficial if used as an adjuvant to: improve analgesia; modulate haemodynamic responses to intubation and pneumoperitoneum and; reduce the number of opioid-associated adverse events. The aim of this study was to evaluate the efficacy and safety of DEX infusion during elective laparoscopic cholecystectomy (LC). Methods: A randomized, single-centre, parallel-group, placebo-controlled study was carried out between May 2016 and June 2017. Adult patients (18–79 years) with American Society of Anesthesiology (ASA) physical status I–II were randomly assigned to 0.5 μg/kg/h DEX infusion from induction of anaesthesia to extubation (Group D; n = 30) or normal saline infusion (Group C; n = 30). The primary efficacy outcomes were postoperative morphine consumption. Secondary efficacy outcomes included: time to first use of rescue analgesia; postoperative morphine consumption; intraoperative fentanyl consumption; time from end of surgery to extubation; lengths of intensive care unit (ICU) and general ward stay; degree of postoperative pain 3, 6, 12 and 24 h after surgery; incidence of persistent post-surgical pain. Results: DEX infusion was associated with a decrease in postoperative morphine consumption (p = 0.001), lower incidence of severe postoperative pain (odds ratio [OR] 9, 95% confidence interval [CI] 1.1–77, p = 0.04) and significantly longer time to first use of rescue analgesia (p = 0.001). Group D also had significantly lower fentanyl consumption both intraoperatively (p = 0.001) and in the time from end of surgery to extubation (p = 0.001) plus decreased incidence of persistent post-surgical pain (OR 14.5, 95% CI 1.7–122, p = 0.005). The incidence of postoperative nausea and vomiting was lower in Group D than Group C (OR 5, 95% CI 1.1–26, p = 0.005). Median pain intensity did not differ between the groups 3, 6, 12 or 24 h after surgery and there were no inter-group differences in the lengths of ICU stay or overall hospital stay between groups. The incidence of hypertension was significantly higher in Group C (OR 13.8, 95% CI 4–48, p < 0.0001); there were no inter-group differences in incidences of hypotension and bradycardia. Conclusions: Intraoperative DEX infusion is safe and effective for improving analgesia during and after elective LC. DEX appears to significantly reduce the number of patients with severe postoperative pain, postoperative morphine consumption and prolong time to first use of rescue analgesia. Trial registration: ClinicalTrials.gov: Retrospectively registered on July 7, 2017, NCT03211871. [ABSTRACT FROM AUTHOR]

Background: Moral Reconation Therapy (MRT) is a cognitive-behavioral intervention aimed at reducing risk for criminal recidivism by restructuring antisocial attitudes and cognitions (i.e., "criminogenic thinking"). MRT has empirical support for reducing risk for criminal recidivism among civilian offenders. Recently, a version of MRT was developed for military veterans; however, no randomized controlled trials (RCT) have been conducted with the veteran-specific protocol, and the effectiveness and implementation potential of MRT outside of correctional settings has not been established.Methods: Using a Hybrid Type 1 RCT design, this study will test the effectiveness of MRT to reduce risk for criminal recidivism and improve health-related outcomes among justice-involved veterans entering mental health residential treatment at three US Veterans Health Administration (VHA) Medical Centers. Upon admission to the treatment program, justice-involved veterans will complete a baseline assessment, be randomized to usual care (UC) or UC + MRT, and be followed 6 and 12 months post-baseline. A process evaluation will also be conducted to identify barriers and facilitators to implementation of MRT in residential treatment.Discussion: The primary aim of this study is to evaluate the effectiveness of MRT with justice-involved veterans. If MRT proves effective in this trial, the findings can provide large healthcare systems that serve veterans with an evidence-based intervention for addressing criminogenic thinking among justice-involved adults, as well as guidance on how to facilitate future implementation of MRT in non-correctional settings.Trial Registration: This trial is funded by the VA Health Services Research & Development Program (IIR 14-081) and is registered with ClinicalTrials.gov (ID: NCT02524171 ). [ABSTRACT FROM AUTHOR]

Background Latino immigrants have high rates of obesity and face barriers to weight loss. Objective To evaluate the effectiveness of a case-management (CM) intervention with and without community health workers (CHWs) for weight loss. Design This was a 2-year, randomized controlled trial comparing two interventions with each other and with usual care (UC). Participants/setting Eligible participants included Latinos with a body mass index of 30 to 60 and one or more heart disease risk factors. The 207 participants recruited during 2009-2010 had a mean age of 47 years and were mostly women (77%). At 24 months, 86% of the sample was assessed. Intervention The CM+CHW (n=82) and CM (n=84) interventions were compared with each other and with UC (n=41). Both included an intensive 12-month phase followed by 12 months of maintenance. The CM+CHW group received home visits. Main outcome measures Weight change at 24 months. Statistical analyses Generalized estimating equations using intent-to-treat. Results At 6 months, mean weight loss in the CM+CHW arm was −2.1 kg (95% CI −2.8 to −1.3) or −2% of baseline weight (95% CI −1% to −2%) compared with −1.6 kg (95% CI −2.4 to −0.7; % weight change, −2%, −1%, and −3%) in CM and −0.9 kg (95% CI −1.8 to 0.1; % weight change, −1%, 0%, and −2%) in UC. By 12 and 24 months, differences narrowed and CM+CHW was no longer statistically distinct. Men achieved greater weight loss than women in all groups at each time point ( P <0.05). At 6 months, men in the CM+CHW arm lost more weight (−4.4 kg; 95% CI −6.0 to −2.7) compared with UC (−0.4 kg; 95% CI −2.4 to 1.5), but by 12 and 24 months differences were not significant. Conclusions This study demonstrated that incorporation of CHWs may help promote initial weight loss, especially among men, but not weight maintenance. Additional strategies to address social and environmental influences may be needed for Latino immigrant populations. [ABSTRACT FROM AUTHOR]