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Abstract: Introduction: Randomization is the most optimal design for evaluating program-effectiveness. In practice, however, conducting a randomized controlled trial is not always feasible. For a non-randomized study into the effect of a parent management training, predefined intervention and control groups of families were matched on six key characteristics. The quality of this match was then compared with the quality which is to be expected from a randomized study. Methods: The performance of matching intervention and control families for predefined and randomized groups was evaluated by simulating new hypothetical intervention and control groups. The Mahalanobis metric was used to assess the distance between families in the intervention and the control groups and pairwise matching was performed. The global distance between these groups was used as measure of the balance of covariates in all matched pairs, with a smaller distance indicating a higher match quality. Results: In the ideal situation, when predefined groups are actually equal to randomized groups, the expected probability of a more equal balance of characteristics in the former groups than in the latter groups is 0.50. Using the data obtained in our study, and our predefined groups, this expected probability was 0.34. Conclusion: Even when randomized groups are more balanced than predefined groups, using the latter groups for analyses might still be acceptable when the differences in group means are small. Findings suggest that matching can be a viable alternative to randomization for situations in which randomization is not feasible due to pragmatic constraints. However, a more accurate judgment on the value of the results obtained in this study requires results from similar analyses performed in other studies for comparison. [Copyright &y& Elsevier]

Abstract: Project STORY is a 3-arm, randomized, planning and feasibility study assessing the effectiveness of two behavioral weight management interventions in an important and at-risk population, overweight children and their parents in medically underserved rural counties. Participants will include 90 parent–child dyads from rural counties in north central Florida. Families will be randomized to one of three conditions: (a) a Family-Based Behavioral Group Intervention, (b) a Parent-Only Behavioral Group Intervention, and (c) a waitlist control condition. Child and parent participants will be assessed at baseline (month 0), post-treatment (month 4) and follow-up (month 10). Assessment and intervention sessions will be held at Cooperative Extension offices within each local participating county. The primary outcome measure is change in child body mass index (BMI) z-score. Additional key outcome measures include child dietary intake, physical activity, self-esteem, body image, and parent BMI. The goals of the study are to (a) assess the feasibility of recruitment in rural settings, (b) develop and evaluate training protocol for group leaders, (c) determine strategies to increase adherence to monitoring and goal setting protocol, (d) evaluate strategies for participant retention, (e) assess the relative cost-effectiveness of the interventions, (f) assess the acceptability of the intervention to families and Cooperative Extension administrators and personnel, and (g) if successful, estimate the sample size needed for a full-scale trial. This research has potential implications for medically underserved rural communities with limited resources and preventive health care services. If successful, a Parent-Only intervention program may provide a cost-effective and practical intervention for families in underserved rural communities. [Copyright &y& Elsevier]

Abstract: Objective: African-American girls and women are at high risk of obesity and its associated morbidities. Few studies have tested obesity prevention strategies specifically designed for African-American girls. This report describes the design and baseline findings of the Stanford GEMS (Girls health Enrichment Multi-site Studies) trial to test the effect of a two-year community- and family-based intervention to reduce weight gain in low-income, pre-adolescent African-American girls. Design: Randomized controlled trial with measurements scheduled in girls'' homes at baseline, 6, 12, 18 and 24 month post-randomization. Setting: Low-income areas of Oakland, CA. Participants: Eight, nine and ten year old African-American girls and their parents/caregivers. Interventions: Girls are randomized to a culturally-tailored after-school dance program and a home/family-based intervention to reduce screen media use versus an information-based community health education Active-Placebo Comparison intervention. Interventions last for 2 years for each participant. Main outcome measure: Change in body mass index over the two-year study. Results: Recruitment and enrollment successfully produced a predominately low-socioeconomic status sample. Two-hundred sixty one (261) families were randomized. One girl per family is randomly chosen for the analysis sample. Randomization produced comparable experimental groups with only a few statistically significant differences. The sample had a mean body mass index (BMI) at the 74th percentile on the 2000 CDC BMI reference, and one-third of the analysis sample had a BMI at the 95th percentile or above. Average fasting total cholesterol and LDL cholesterol were above NCEP thresholds for borderline high classifications. Girls averaged low levels of moderate to vigorous physical activity, more than 3 h per day of screen media use, and diets high in energy from fat. Conclusions: The Stanford GEMS trial is testing the benefits of culturally-tailored after-school dance and screen-time reduction interventions for obesity prevention in low-income, pre-adolescent African-American girls. [Copyright &y& Elsevier]

Abstract: Obesity prevalence is increasing in the U.S., especially among children and minority populations. This report describes the design and baseline data of the ongoing Girls health Enrichment Multi-site Studies (GEMS) trial (Memphis site), which is testing the efficacy of a 2-year family-based intervention to reduce excessive increase in body mass index (BMI). This randomized, controlled trial conducted at community centers in Memphis, Tennessee requires major measurements at baseline and at 12 and 24 months post-randomization. The participants are healthy African-American girls and one parent/caregiver of each girl. Participating girls are of ages 8–10 years, with BMI≥25th percentile of the CDC 2000 growth charts or with one overweight or obese parent/caregiver (BMI≥25 kg/m2). The active intervention is designed to prevent excessive weight gain by promoting healthy eating habits and increasing physical activity. An alternative intervention (comparison group) promotes general self-esteem and social efficacy. The main outcome measure is the difference between the two treatment groups in the change in BMI at 2 years. Three hundred and three girls have been randomly assigned to receive the test intervention (n =153) or the alternative intervention (n =150). The two groups do not differ in baseline characteristics. At the time of enrollment, the mean age was 9 years, the mean BMI was 22 kg/m2 (mean BMI percentile=77th), and 41% were overweight (BMI≥95th percentile using CDC 2000 growth charts). Participants'' intake of fruits and vegetables (1.3 serving/day) and fats (36% kcal), and their participation in moderate-to-vigorous physical activity (20 min/day), did not meet national recommendations. The GEMS obesity prevention intervention targets improved diet and increased physical activity to reduce excessive weight gain in healthy African-American girls of ages 8–10. [Copyright &y& Elsevier]

Abstract: Background: Students attending ‘alternative’ high schools form relatively small, highly mobile high-risk populations, presenting challenges for the design and implementation of HIV-, other STI-, and pregnancy-prevention interventions. This paper describes the rationale, study design, and baseline results for the Safer Choices 2 program. Study design: Modified group-randomized intervention trial with cross-over of schools but not of students. The study cohort was defined a priori as those who completed the baseline measures and were still enrolled at the time of first follow-up. Design results: Of 940 students initially enrolled in the study, 711 (76%) formed the study cohort. There were significant demographic differences between those included and those excluded from the study cohort in sex, age, sexual experience, experience with pregnancy, drug use, and some psychosocial measures. There were no significant differences between the intervention and control groups within the study cohort. The only significant difference between those students excluded from the intervention group and those excluded from the control group was reported age at first intercourse. Baseline data results: Students (n =940) enrolled were predominately African-American (29.7%) and Hispanic (61.3%); 57.3% were female; 66% had ever had sex; and reported drug use in the previous 30 days ran from 4.3% (cocaine) to 26.9% (marijuana). Of the 627 sexually experienced, 41.8% reported their age at first intercourse as 13 years or younger; 28.5% reported ever being or having gotten someone pregnant; 74% reported sex in the past 3 months. Of the 464 sexually active in the last 3 months, 55.4% reported unprotected intercourse and 31.3% reported using drugs beforehand. Conclusion: The cross-over design will provide a rigorous test of the intervention; however, loss to follow-up of this population can result in some selection bias. Students attending dropout prevention and recovery schools are at high risk for HIV, STIs, and pregnancy, and are in need of interventions. [Copyright &y& Elsevier]

Abstract: Objectives: To address participants'' knowledge of informed consent and to explore whether knowledge level is related to clinical trial satisfaction. Methods: One hundred and fourteen patients enrolled in three ongoing randomized controlled trials of osteoarthritis and rheumatoid arthritis were asked to complete a mailed form. The survey was related to aspects of the informed consent process: quality of information given during the informed consent process, participants'' self perception of knowledge, objective evaluation of participants'' knowledge and participants'' overall trial satisfaction. These four aspects were categorized as high, intermediate or low. Correlation between participants'' knowledge and satisfaction was measured using the Spearman''s Rho test and variables associated with knowledge by standard univariable analyses. A p value≤0.05 was considered significant. Results: One hundred and five participants answered the questionnaire. The quality of information given during the informed consent process was rated as being high by 81% participants, intermediate by 15.2% and low by 3.8%. Fifty-one percent of the participants believed they had a good level of knowledge, but, objective evaluation qualified as high in only 14.3% of them. Overall trial satisfaction was high in 95% of the participants. No significant correlation was found between knowledge and satisfaction (r=0.16; p =0.086). Age was negatively associated with a higher level of knowledge (48 vs. 58 years old, p =0.008). Conclusions: We found a lack of correlation between satisfaction and knowledge in clinical trials participants. During a randomized controlled trial the investigator should consider encouraging activities to improve not only participants'' satisfaction, but also their level of knowledge. [Copyright &y& Elsevier]

Abstract: Background: The rising prevalence of obesity in children and adolescents is implicated in the metabolic abnormalities that track into adulthood. The associated increased incidence of insulin resistance, metabolic syndrome and type 2 diabetes being identified in younger cohorts has given rise to a critical global health issue. Muscular strength is a vital component of metabolic fitness that provides protection from insulin resistance in adults, and we have recently shown this to be true in children as well. Targeting muscular strength deficiencies at an early age may be an effective preventative strategy for metabolic syndrome and type 2 diabetes. Purpose: There is limited evidence-based best practice for progressive resistance training (PRT), adiposity and metabolic fitness in children and adolescents. The purpose of this paper is to describe the methodology we utilized for implementing a PRT program to avoid publication bias, enable replication of the study and share a novel program that we have found safe and suitable for use with youth. Methods: We conducted the first randomized controlled trial (RCT) prescribing high-intensity PRT to children and adolescents (10–15 years) as a community-based primary prevention program to address adiposity and metabolic health. Participants were instructed to complete 2 sets of 8 repetitions of 11 exercises targeting all the major muscle groups twice a week at an RPE of 15–18 for 8 weeks. Results: Primary outcome was waist circumference; secondary outcomes included insulin resistance, lipid levels, muscle strength, cardiorespiratory fitness, body composition, self-efficacy, self-concept, habitual physical activity, nutritional and sedentary behavior patterns. Conclusion: The supervised PRT program that we used with children and adolescents has been described in detail. The efficacy of this modality of exercise for metabolic fitness and other health outcomes is now under investigation. [Copyright &y& Elsevier]

Abstract: If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting Trials (CONSORT) were developed to improve the suboptimal reporting of RCTs. We aimed to determine the extent to which RCTs report key methodological factors included in the revised CONSORT recommendations following publication of these recommendations. We conducted an observational study of RCTs published between July 2002 and June 2003 in 5 leading general medicine journals. We determined the proportion and 95% confidence intervals of RCTs that reported sequence generation, allocation concealment, randomization implementation, blinding status of participants, health care providers, outcome assessors, and data analysts, sample size justification, method of analysis (e.g. intention-to-treat), and a participant flow diagram. We included a total of 253 RCTs. RCTs reported: sequence generation 80% (95% CI 75–80%), allocation concealment 48% (95% CI 42–54%), randomization implementation 55% (95% CI 49–61%), blinding status of participants 40% (34–46%), health care providers 17% (95% CI 13–22%), outcome assessors 47% (95% CI 41–53%), data analysts 15% (10–19%), sample size justification 83% (95% CI 78–87%), method of analysis 87% (95% CI 83–91%)), and participant flow diagrams 86% (95% CI 82–90%). Although reporting of some CONSORT recommendations is high, reporting of several essential recommendations remains suboptimal. Authors need to comply with and journals need to enforce reporting of the revised CONSORT recommendations. [Copyright &y& Elsevier]

Abstract: In studies of chronic disease the outcome measure may be based upon the duration of recurring illness. Our example is the UK700 trial of psychiatric case management, where the total number of days spent in hospital over a 2-year follow-up was the primary outcome. Investigations of treatment effect modifiers were undertaken using an analysis of that primary outcome, a comparison of length of hospitalizations, and also a multi-state modeling approach. The days in hospital outcome was relatively straightforward to analyze, and allowed the complete randomized treatment groups to be compared. In contrast, the comparison of length of hospitalizations included only hospitalized patients, with censored observations not being well accommodated. The multi-state model provided separate treatment effect estimates for admission and discharge, this being more informative about how any reduction in days spent in hospital is achieved. Estimation of the treatment effects through the use of proportional hazards regression allowed appropriate incorporation of censored observations. However, with the multi-state model approach treatment effect estimates are not based upon comparisons of complete randomized treatment groups, as individuals are removed from the risk set for admission whilst at risk for discharge, and vice versa. We conclude that total duration is an appropriate primary outcome for clinical trials, but that multi-state models deserve greater use as an informative secondary analysis. [Copyright &y& Elsevier]

Abstract: Double-blinded trials are often considered the gold standard for research, but significant bias may result from unblinding of participants and investigators. Although the CONSORT guidelines discuss the importance of reporting “evidence that blinding was successful”, it is unclear what constitutes appropriate evidence. Among studies reporting methods to evaluate blinding effectiveness, many have compared groups with respect to the proportions correctly identifying their intervention at the end of the trial. Instead, we reasoned that participants'' beliefs, and not their correctness, are more directly associated with potential bias, especially in relation to self-reported health outcomes. During the Water Evaluation Trial performed in northern California in 1999, we investigated blinding effectiveness by sequential interrogation of participants about their “blinded” intervention assignment (active or placebo). Irrespective of group, participants showed a strong tendency to believe they had been assigned to the active intervention; this translated into a statistically significant intergroup difference in the correctness of participants'' beliefs, even at the start of the trial before unblinding had a chance to occur. In addition, many participants (31%) changed their belief during the trial, suggesting that assessment of belief at a single time does not capture unblinding. Sequential measures based on either two or all eight questionnaires identified significant group-related differences in belief patterns that were not identified by the single, cross-sectional measure. In view of the relative insensitivity of cross-sectional measures, the minimal additional information in more than two assessments of beliefs and the risk of modifying participants'' beliefs by repeated questioning, we conclude that the optimal means of assessing unblinding is an intergroup comparison of the change in beliefs (and not their correctness) between the start and end of a randomized controlled trial. [Copyright &y& Elsevier]

Over 100 million adults in the United States have hypertension. The DASH (Dietary Approaches to Stop Hypertension) eating pattern is an evidence-based first-line treatment option for hypertension; however, adherence to the DASH eating pattern at a population level remains low. To address this gap, we will implement Nourish, a randomized controlled efficacy trial that will leverage a commercially-available smartphone application and evidence-based behavior change principles to improve adherence to the DASH eating pattern among adults with hypertension. The Nourish trial is a two-arm, 12-month randomized control trial that will enroll adults (N = 300) with hypertension, defined as a systolic blood pressure of 120–159 mmHg; a diastolic blood pressure of 80–99 mmHg; and/or adults on blood pressure-lowering medication. Nourish will test the efficacy of a digital health intervention, as compared to the attention control arm, on DASH eating pattern adherence and blood pressure. Intervention components will include skills training, self-monitoring, personalized feedback, and responsive coaching. The primary outcome of the trial is 6-month changes in adherence to the DASH eating pattern, as measured by 24-h dietary recalls. Millions of Americans remain in need of effective behavioral interventions to manage and improve their hypertension and its adverse consequences. The ubiquity of smartphones offers a promising approach to disseminate the DASH eating pattern. By leveraging these widely used smartphone applications, combined with evidence-based behavior change principles and the DASH eating plan, Nourish will demonstrate the effectiveness of a digital health intervention to improve DASH adherence, and ultimately, to reduce blood pressure. Trial Number: NCT03875 [ABSTRACT FROM AUTHOR]

Clopidogrel and aspirin are key intervention for acute ischemic stroke (AIS) and transient ischemic attack (TIA). However, with increased clinical application, many patients have shown clopidogrel resistance (CR) and/or aspirin resistance (AR) that affect antiplatelet therapy on AIS/TIA. At present, there is no research reported on personalized antiplatelet therapy guidelines for patients with CR and/or AR. Our study aims to assess the effect of personalized antiplatelet therapy based on CYP2C19 genotype and urine 11-dhTxB2 tests in patients with AIS or TIA. This is a multi-center randomized controlled trial. Eligible patients with AIS/TIA from 14 comprehensive hospitals in Jiangxi province will be recruited after obtaining informed consent. Participants will be randomly divided into the intervention group and the control group at a ratio of 1:1. personalized antiplatelet therapy based on the CYP2C19 genotype/urine11-dhTxB2 tests will be given to the intervention group. Demographics, disease history, laboratory investigations, therapys, physiological tests, imaging reports and other clinical features will be collected. Clinical outcomes including stroke recurrence, Modified Rankin Scale (mRS) score, bleeding events and all-cause mortality will be assessed at the 1st, 3rd, 6th, and 12th-month post-discharge. Our study will conduct free antiplatelet resistance tests and personalized antiplatelet therapy for AIS/TIA patients with CR/AR, ultimately evaluating personalized therapy effectiveness through one-year follow-up. The research results will help to assess the impact of personalized antiplatelet therapy on the prognosis of stroke, thus providing reference for precise clinical treatment. • This study may provide a reference for clinical treatment and prescribing guidelines for AIS/TIA patients with clopidogrel and/or aspirin resistance.. • This study will explore the CYP2C19 genotype distribution and the frequency of aspirin resistanceand potential factors that affect the prognosis and safety in Chinese AIS/TIA patients. [ABSTRACT FROM AUTHOR]

Post-traumatic stress disorder (PTSD), prevalent among Veterans, increases risk for having a high Body Mass Index. Although the Veterans Health Administration (VHA) offers an evidence-based behavioral weight management program called MOVE!, participants with PTSD lose less weight than those without mental health conditions, despite comparable participation. PTSD symptoms can interfere with one's ability to be physically active and maintain a healthy diet, the key targets in weight management programs. We developed and piloted a behavioral weight management program called MOVE! + UP that targets PTSD-related weight loss barriers. MOVE! + UP includes 16 group sessions with training in evidence-based weight management strategies, coupled with Cognitive Behavior Therapy (CBT) skills to address PTSD-specific barriers. The 16 sessions also include 30-min community walks to address PTSD-related barriers that may impede exercise. Two individual dietician sessions are provided. This hybrid type 1 randomized controlled trial (RCT) will compare MOVE! + UP to standard care—MOVE!—among 164 Veterans with BMI ≥ 25 who are receiving care for PTSD. We will randomize participants to MOVE! + UP or standard care and will compare absolute post-baseline change in weight at 6 (primary outcome) and 12 (secondary outcome) months, and PTSD symptom severity at 6 and 12 months (secondary outcome). Exploratory analyses will compare the treatment conditions on treatment targets measured at 6 months (e.g., physical activity, eating behavior, social support). Finally, we will estimate intervention costs, and identify MOVE! + UP implementation barriers and facilitators. If effective, MOVE! + UP could be an efficient way to simultaneously address physical and mental health for Veterans with PTSD. [ABSTRACT FROM AUTHOR]

Posttraumatic stress disorder (PTSD) can be a severe problem, affecting veterans and military personnel at higher rates than the general community. First-line treatment for PTSD, prolonged exposure (PE), is typically delivered weekly for 10–12 weeks, however this duration can pose a barrier to accessing and completing the treatment, particularly for current serving military. This paper presents the RESTORE trial protocol, the first randomized controlled trial of massed PE therapy outside of the United States and by an independent research group. One hundred and thirty-five Australian Defence Force members and veterans (18–80 years) who meet criteria for PTSD related to a military trauma will be randomly allocated to one of two conditions: standard PE (SPE; 10 weekly 90-min sessions) or massed PE (MPE; 10 daily 90-min sessions). Across eight sites, patients will be assessed at pre-treatment, and at 4 weeks, 12 weeks, and 12 months post-treatment commencement. The primary outcome is clinician-measured and self-reported PTSD symptom severity at the 12 week assessment. We hypothesize that MPE will be as effective as SPE in reducing PTSD severity at 12 weeks post-treatment commencement. The adaptation and testing of evidence-based interventions is critical to reduce barriers to treatment uptake among veterans and military personnel. Outcomes of this study have the potential to result in international, cross-service uptake and delivery of this rapid treatment for veterans and military members, as well as civilians, thereby improving clinical outcomes for patients and their families. [ABSTRACT FROM AUTHOR]

Survivors of head and neck cancer (HNC) can have multiple health concerns. To facilitate their care, we developed and pilot-tested a clinical informatics intervention, HN-STAR. HN-STAR elicits concerns online from HNC survivors prior to a routine oncology clinic visit. HN-STAR then presents tailored evidence-based clinical recommendations as a clinical decision support tool to be used during the visit where the oncology clinician and survivor select symptom management strategies and other actions. This generates a survivorship care plan (SCP). Online elicitation of health concerns occurs 3, 6, and 9 months after the clinic visit, generating an updated SCP each time. HN-STAR encompasses important methods of improving survivorship care (e.g., needs assessment, tailored interventions, dissemination of guidelines) and will be evaluated in a pragmatic trial to maximize external validity. This hybrid type 1 implementation-effectiveness trial tests HN-STAR effectiveness while studying barriers and facilitators to implementation in community oncology practices within the National Cancer Institute Community Oncology Research Program. Effectiveness will be measured as differences in key survivorship outcomes between HNC participants who do and do not use HN-STAR over one year after the clinic visit. The primary endpoint is HNC-specific quality of life; other outcomes include patient-centered measures and receipt of guideline-concordant care. Implementation outcomes will be assessed of survivors, providers, and clinic stakeholders. The hybrid design will provide insight into a dose-response relationship between the extent of implementation fidelity and effectiveness outcomes, as well as how to incorporate HN-STAR into standard practice outside the research setting. [ABSTRACT FROM AUTHOR]

This randomized controlled trial aims to determine the feasibility and preliminary efficacy of a patient-centered, mobile health technology intervention (iCardia4HF) in patients with chronic Heart Failure (HF). Participants (n = 92) are recruited and randomized 1:1 to the intervention or control group. The intervention group receives a commercial HF self-care app (Heart Failure Storylines), three connected health devices that interface with the app (Withings weight scale and blood pressure monitor, and Fitbit activity tracker), and a program of individually tailored text-messages targeting health beliefs, self-care self-efficacy, HF-knowledge, and physical activity. The control group receives the same connected health devices, but without the HF self-care app and text messages. Follow-up assessments occur at 30 days and 12 weeks. The main outcome of interest is adherence to HF self-care assessed objectively through time-stamped data from the electronic devices and also via patient self-reports. Primary measures of HF self-care include medication adherence and adherence to daily weight monitoring. Secondary measures of HF self-care include adherence to daily self-monitoring of HF symptoms and blood pressure, adherence to low-sodium diet, and engagement in physical activity. Self-reported HF self-care and health-related quality of life are assessed with the Self-care Heart Failure Index and the Kansas City Cardiomyopathy Questionnaire, respectively. Hospitalizations and emergency room visits are tracked in both groups over 12 weeks as part of our safety protocol. This study represents an important step in testing a scalable mHealth solution that has the potential to bring about a new paradigm in self-management of HF. [ABSTRACT FROM AUTHOR]

Sedentary behavior increases the risk for multiple chronic diseases, early mortality, and accelerated cognitive decline in older adults. Interventions to reduce sedentary behavior among older adults are needed to improve health outcomes and reduce the burden on healthcare systems. We designed a randomized controlled trial that uses a self-affirmation manipulation and gain-framed health messaging to effectively reduce sedentary behavior in older adults. This message-based intervention lasts 6 weeks, recruiting 80 healthy but sedentary older adults from the community, between the ages of 60 and 95 years. Participants are randomly assigned to one of two groups: 1) an intervention group, which receives self-affirmation followed by gain-framed health messages daily or 2) a control group, which receives daily loss-framed health messages only. Objective physical activity engagement is measured by accelerometers. Accelerometers are deployed a week before, during, and the last week of intervention to examine potential changes in sedentary time and physical activity engagement. Participants undertake structural and functional (resting and task-based) MRI scans, neuropsychological tests, computerized behavioral measures, and neurobehavioral inventories at baseline and after the intervention. A 3-month follow-up assesses the long-term maintenance of any engendered behaviors from the intervention period. This study will assess the effectiveness of a novel behavioral intervention at reducing sedentarism in older adults and examine the neurobehavioral mechanisms underlying any such changes. [ABSTRACT FROM AUTHOR]

PTSD is associated with serious problems in interpersonal functioning, including higher rates of marital conflict and divorce, disrupted relationships with family and friends, estrangement from others and social isolation. Cognitive behavioral and trauma focused treatments are effective for treating PTSD symptoms, but a substantial proportion of individuals, particularly veterans, with PTSD, do not engage, complete, or fully respond to these treatments, and the effects of these treatments on interpersonal functioning are unknown. There is a critical need for alternative treatments with established efficacy, and for treatments that directly address problems in relationship functioning. Interpersonal Psychotherapy for PTSD (IPT-PTSD) is a promising candidate for such a treatment. This paper describes the rationale, design, and methods of the first randomized controlled equivalence trial comparing IPT-PTSD with a first-line gold standard treatment for PTSD (Prolonged Exposure; PE) in the treatment of PTSD in veterans. Both treatments include up to 12 weekly individual sessions. Assessments were conducted at baseline, following sessions four and eight, end of treatment, and 3 and 6 months post-treatment. Primary hypotheses are that IPT-PTSD will be statistically equivalent to PE in reducing the severity of PTSD symptoms, and superior to PE in improving interpersonal functioning. Secondary hypotheses propose that IPT will be superior to PE in improving overall social adjustment and quality of life, and in reducing suicidal ideation. Findings from this study have the potential to improve treatment options for veterans struggling with PTSD and interpersonal problems. [ABSTRACT FROM AUTHOR]

Post-natal HIV infection through breastfeeding remains a challenge in many low and middle-income countries, particularly due to non-availability of alternative infant feeding options and the suboptimal Prevention of Mother to Child Transmission of HIV-1 (PMTCT) cascade implementation and monitoring. The PROMISE-EPI study aims to address the latter by identifying HIV infected mothers during an almost never-missed visit for their infant, the second extended program on immunization visit at 6–8 weeks of age (EPI-2). The study is divided into 3 components inclusive of an open-label randomized controlled trial aiming to assess the efficacy of a responsive preventive intervention compared to routine intervention based on the national PMTCT guidelines for HIV-1 uninfected exposed breastfeeding infants. The preventive intervention includes: a) Point of care testing for early infant HIV diagnosis and maternal viral load; b) infant, single-drug Pre-Exposure Prophylaxis (PrEP) (lamivudine) if mothers are virally unsuppressed. The primary outcome is HIV-transmission rate from EPI-2 to 12 months. The study targets to screen 37,000 mother/infant pairs in Zambia and Burkina Faso to identify 2000 mother/infant pairs for the clinical trial. The study design and challenges faced during study implementation are described, including the COVID-19 pandemic and the amended HIV guidelines in Zambia in 2020 (triple-drug PrEP in HIV exposed infants guided by quarterly maternal viral load). The changes in the Zambian guidelines raised several questions including the equipoise of PrEP options, the standard of care-triple-drug (control arm in Zambia) versus the study-single-drug (intervention arm). Trial registration number (www.clinicaltrials.gov): NCT03869944. Submission category : Study Design, Statistical Design, Study Protocols. [ABSTRACT FROM AUTHOR]

Hospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge. A randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose. We describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial. Study findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population. [ABSTRACT FROM AUTHOR]

Many studies have used the internet to promote physical activity (PA) in several settings, including the home environment, but few have been tailored for African Americans (AAs). To address this research gap, we conducted focus groups with AAs to inform the development of a web-based intervention, Physical Activity for The Heart (PATH), that leverages openly accessible platforms, such as YouTube, to promote PA in any setting. To describe the rationale and design of a pilot randomized clinical trial (RCT), that examines the feasibility and acceptability of the PATH intervention among 30 AA adults aged 40‐–70 years without history of cardiovascular disease. A 12-week, single-site, wait-listed RCT with subjects randomized 1:1 to either: 1) treatment group - participants receive the PATH intervention, including the online portal and twice a month phone calls from a PA coach, or 2) attention control group - participants receive a self-help PA handout and twice a month general health newsletter. All participants self-monitor step count using actigraphy. The primary outcomes of this 12-week, pilot RCT are recruitment, retention, and adherence to self-monitoring (Actigraph wear time) and the intervention protocol (PATH utilization). The secondary outcomes include changes in PA (step count, moderate-to-vigorous PA, exercise self-efficacy), and cardiometabolic risk (HbA1C, HDL, LDL, total cholesterol, type 2 diabetes risk score, percent body fat, weight, and waist circumference) from baseline to 12 weeks. This study will provide PATH intervention feasibility and acceptability data among inactive AA adults and will inform a future, full-scale RCT testing efficacy. [ABSTRACT FROM AUTHOR]

When conducting clinical trials comparing over-the-counter (OTC) medications, the wide availability of these treatments are a potential challenge to maintaining study integrity. We seek to describe adherence to a study protocol involving widely available OTC medications. To prospectively evaluate associations between acetaminophen use and asthma in 300 children aged 1–5 years, we conducted a double blind, randomized, controlled trial where parents administered blinded forms of either acetaminophen or ibuprofen as needed to their children over a 48 week period. Written and verbal instructions encouraged the exclusive use of the blinded study medication and discouraged OTC use. Adherence was determined by evaluating the frequency of use of per-protocol blinded study medication compared to off-protocol use of OTC medications. 4195 doses of acetaminophen or ibuprofen were received by children during the study which included 3664 doses (87.3%) of blinded study medication adhering to the protocol and 531 doses (12.7%) of OTC products deviating from the protocol with better adherence among those randomized to ibuprofen as compared to acetaminophen (89.5% vs. 85.5% of doses, p < 0.01). Individually, 227 participants (75.7%) remained fully adherent by not receiving any OTC medications. Pre-study preference for either acetaminophen or ibuprofen by the participants' families was not associated with differential rates of adherence to the blinded medication. This parallel study demonstrated greater than 85% of acetaminophen or ibuprofen doses were blinded study medications adhering to the protocol while less than 15% were OTC deviations from the protocol. This successfully implemented study design provides a template to comparatively evaluate these and other OTC medications. [ABSTRACT FROM AUTHOR]

Perceived cognitive impairment (PCI) and sleep disturbances (such as insomnia) are commonly reported barriers preventing cancer survivors from resuming normal functioning. Cognitive-behaviour therapy for insomnia (CBT-I) is the treatment of choice for insomnia among cancer survivors. Literature suggests that treatment with CBT-I may lead to an improvement in PCI, but this needs to be tested in a sample of patients with PCI at study entry with cognitive impairments as the primary study outcome. Here we describe the design of a clinical trial to evaluate the efficacy of videoconference-delivered CBT-I for the improvement of PCI among cancer survivors. This project is a randomized waitlist-controlled trial with a recruitment target of 124 adult cancer survivors (solid tumors and hematological malignancies) who have completed primary treatment at least 6 months prior, report PCI and meet criteria for insomnia disorder. Participants will complete assessments at baseline, 4 weeks (mid-treatment), 8 weeks (post treatment), and 3 and 6 months post-treatment. The primary outcome is the Functional Assessment of Cancer Therapy – Cognitive Function (FACT-Cog). Treatment of PCI in cancer patients is a priority for clinicians, researchers, and patients. This research will increase our understanding of the mechanisms of cognitive impairment associated with cancer, and potentially expand currently available treatment options. • Cancer survivors often report insomnia and perceived cognitive impairment. • Cognitive-behaviour therapy for insomnia (CBT-I) is the top treatment for insomnia. • This study will use videoconference delivered CBT-I to increase the availability. • CBT-I may also lead to an improvement in perceived cognitive impairment (PCI). • This trial will evaluate the efficacy of CBT-I for improving PCI in cancer survivors. [ABSTRACT FROM AUTHOR]

People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will result in better outcomes is presently unknown. The Whole Health Study is a 3-arm randomized controlled trial designed to test collaborative care treatment for OUD and the psychiatric disorders that commonly accompany OUD. Approximately 1200 primary care patients aged ≥18 years with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions: (1) Augmented Usual Care, which consists of a primary care physician (PCP) waivered to prescribe buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment; (2) Collaborative Care, which consists of a waivered PCP, a mental health care manager trained in psychosocial treatments for OUD and psychiatric disorders, and an addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders. The Whole Health Study will investigate whether collaborative care models that address OUD and co-occurring depression, anxiety, or PTSD will result in better patient outcomes. The results will inform clinical care delivery during the current opioid crisis. www.clinicaltrials.gov registration: NCT04245423 [ABSTRACT FROM AUTHOR]

Background: There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. Despite clinical guidelines and education, prescribing continues at a higher rate than before the opioids crisis. The objective of trial 1 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-1) is to discourage unnecessary opioid prescribing in primary care by applying "behavioral insights"—empirically-tested social and psychological interventions that affect choice. Methods: AESOPS-1 randomizes primary care clinics in Illinois and California to behavioral intervention or control. Both arms receive opioid guideline education. Clinics randomized to the behavioral intervention arm receive nudges within the electronic health record (EHR) including: 1) an "accountable justification" entered in the chart, 2) a precommitment to address high-risk prescriptions, and 3) a "PainTracker" that broadens discussions about pain. The control arm receives no EHR-based intervention. The primary outcome is the change in weekly milligram morphine equivalents (MME) prescribed. The secondary outcome is the change in the proportion of patients prescribed at least 50 daily MME. To evaluate these outcomes, we will use a difference-in-differences mixed-effects regression model on clinician MME weekly or daily dose. The analysis will be "intent-to-treat." The intervention period is 18-months, with a 6-month follow-up period to measure persistence of effects. Discussion: The AESOPS-1 trial will evaluate the effect of EHR-based interventions in reducing noncancer opioid prescribing in primary care. AESOPS-1 may demonstrate practical and scalable strategies to lower unnecessary population exposure to opioids. [ABSTRACT FROM AUTHOR]

Adolescents with anorexia nervosa have set-shifting inefficiencies that can be exacerbated by starvation and that may interfere with outcomes of treatment interventions. Cognitive Remediation Therapy (CRT), an adjunctive treatment focused on improving set-shifting, can target inefficiencies and may augment treatment effectiveness. The best way to add CRT to the standard of care (Family Based Treatment, FBT) for adolescents with anorexia remains understudied. This is a randomized controlled trial designed to determine if CRT is effective in increasing flexibility in adolescents with anorexia and/or their parents. Participants are adolescents 12–18 years old with anorexia and their parents. 54 family groups will be randomized into one of three groups: FBT only, FBT plus Parent-focused CRT, or FBT plus Adolescent-focused CRT. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study. This is the first study of its kind to apply CRT to parents. All forms of CRT in the context of anorexia have targeted the individual with anorexia's thinking style. We propose that it may be impactful to target the parent of the adolescent with anorexia as parents carry the burden of treatment and re-nourishment of their child during FBT and may have similar thinking styles. This study takes an experimental therapeutics approach to further our understanding of the mechanisms of treatment for adolescents with anorexia. It focuses on increasing cognitive flexibility in patients or their parents and determining the appropriate dose of CRT needed to achieve positive change. ClinicalTrails.gov Identifier NCT03928028 [ABSTRACT FROM AUTHOR]

Thoughtful approaches to study recruitment are a critical step in designing and implementing randomized controlled trials. Delays and challenges in recruitment can be costly and can result in smaller than proposed sample sizes which have downstream effects, such as underpowered studies. The current study evaluated recruitment methods (e.g., targeted mailings, brochures/flyers, social media) and their relationship to eligibility, randomization, participant characteristics and retention at end of a randomized controlled trial of physical activity adoption and maintenance among breast cancer survivors. Screening data from 874 women was analyzed for recruitment method, study eligibility, randomization and retention through end of treatment. Costs per randomized participant were calculated by recruitment method. Baseline participant characteristics were compared across recruitment methods and between randomized and retained participants. Rates of participant accrual from eligibility screening through randomization differed statistically significantly depending on recruitment method (p <.05). The highest randomization rates were obtained via targeted mailings (88.2%) and lowest via brochure/flyer (0.4%). Among the randomized sample, there were no differences in demographic characteristics between recruitment methods, however, there were differences within the targeted mailings category (registries vs. organizational recruitment). There were statistically significant differences in costs between recruitment methods (p <.001) with lowest (non-negligible) cost being targeted mailings. The current RCT of breast cancer survivors successfully recruited and retained participants, highlighting the need to combine recruitment methods to achieve accrual goals. Recruitment methods differed substantially in their cost and their ability to attract individuals who would ultimately be randomized. [ABSTRACT FROM AUTHOR]

Delirium in the intensive care unit (ICU) affects up to 80% of critically ill, mechanically ventilated (MV) adults. Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors. The purpose of this randomized controlled trial is to test the effectiveness of a Family Automated Voice Reorientation (FAVoR) intervention on delirium among critically ill MV patients. The FAVoR intervention uses scripted audio messages, which are recorded by the patient's family and played at hourly intervals during daytime hours. This ongoing orientation to the ICU environment through recorded messages in a voice familiar to the patient may enable the patient to more accurately interpret the environment and thus reduce risk of delirium. The study's primary aim is to test the effect of the FAVoR intervention on delirium in critically ill MV adults in the ICU. The secondary aims are to explore: (1) if the effect of FAVoR on delirium is mediated by sleep, (2) if selected biobehavioral factors moderate the effects of FAVoR on delirium, and (3) the effects of FAVoR on short-term and long-term outcomes, including cognition and health status. Subjects (n = 178) are randomly assigned to the intervention or control group within 48 h of initial ICU admission and intubation. The intervention group receives FAVoR over a 5-day period, while the control group receives usual care. Delirium-free days, sleep and activity, cognition, patient-reported health status and sleep quality, and data regarding iatrogenic/environmental and biobehavioral factors are collected. [ABSTRACT FROM AUTHOR]

Alzheimer's dementia (AD) is the sixth leading cause of death in the U.S., with an estimated $305 billion cost of care in 2020. Currently there are no cures or therapies to ameliorate the disease progression and symptoms. Growing evidence links a diet characterized by high antioxidant components with benefits to cognitive function, which is indicative of the preventative potential of dietary inteventions. The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study is a 3-year, multicenter, randomized controlled trial to test the effects of the MIND diet on cognitive function in 604 individuals at risk for AD. Men and women ages 65 to 84 years were recruited. Eligible participants were randomized to either the MIND diet with mild caloric restriction or their usual diet with mild caloric restriction. Cognitive assessments, medical history, blood pressure, anthropometric measurements, and blood and urine sample collections will be taken at baseline and follow-up visits. MRI scans will be completed on approximately half of the enrolled participants at the start and end of the study. Unique features of the MIND study include: 1) a dietary pattern, rather than single nutrient or food, tested in an at-risk population; 2) foods featured as key components of the MIND diet (i.e. extra-virgin olive oil, blueberries, and nuts) provided for participants; and 3) MRI scans of brain structure and volume that may provide potential mechanistic evidence on the effects of the diet. Results from the study will be crucial to the development of dietary guidelines for the prevention of AD. [ABSTRACT FROM AUTHOR]

Nearly half of Americans live with chronic disease. Many have multiple chronic conditions that often present as a combination of physical and mental health conditions. Aligning stakeholder-driven, patient-centered outcomes research with population health strategies such as innovative ways to deliver care management can reduce the burden of multiple chronic conditions. In addition, successfully creating meaningful, inclusive research requires actively engaging stakeholders throughout the lifecycle of a study. This study integrates stakeholder engagement, using a large health plan in western Pennsylvania, to conduct a randomized controlled trial. Three care management strategies, High-Touch, High-Tech, and Usual Care, are compared for effectiveness among members with multiple chronic conditions. Care strategies are delivered via the Community Team, a multidisciplinary community-based team, offering in-person (High-Touch) and digital (High-Tech) care management in 14 counties across Pennsylvania. Participants are followed for 12 months, with repeated measurements of self-reported health status and activation in care, while tracking administrative measurements of primary and specialty health service utilization. Quality of life, care satisfaction, engagement in care, and service utilization will be compared using generalized mixed models. Additionally, semi-structured interviews are conducted for both participants and care managers over the course of the study to evaluate feasibility. This manuscript presents implementation strategies, while noting that the implementation of patient-centered outcomes research in a real-world setting requires rapid evaluation, redesign of workflow, and tailored approaches for success. [ABSTRACT FROM AUTHOR]

The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use in the context of smoking cessation to reduce the risk for smoking relapse. In this paper we describe the development of mindfulness-based relapse prevention for smoking cessation and alcohol modification (MBRP-SA) and pilot study findings (Phase 1). Next, details regarding the methods and design of an ongoing, randomized controlled trial, Project RISE (Phase 2), are described. MBRP-SA is a group-based intervention that consists of eight weekly treatment sessions. Results from the Phase 1 pilot study (N = 21 enrolled) indicated that participants planned to use the skills learned in their everyday activities and to address their smoking and alcohol goals. Based on the progression of Phase 1 cohorts, modifications were made to the inclusion/exclusion criteria and recruitment methods that will be implemented in Phase 2. Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification. [ABSTRACT FROM AUTHOR]

Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization – the gold standard for assessing causality – has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a condition for the subset of beneficiaries deemed able-bodied to maintain eligibility for benefits. Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program. To address potential bias from differential attrition from the Medicaid program that would accrue from solely analyzing administrative data, our team designed a rich, prospective, longitudinal survey to collect primary and secondary outcomes from six categories of interest to policymakers: insurance coverage, health care utilization and quality, health behaviors, socioeconomic measures, personal finances, and health outcomes. At baseline, a subset of survey participants was invited to participate in the collection of biometric samples via in-person follow-up visits, and a cross-section were also invited to participate in qualitative interviews. While the demonstration waiver was terminated before the program began, our study design illustrates that it is possible for other researchers and state agencies seeking to evaluate Medicaid demonstration waivers and other demonstration policies to work together to implement high quality randomized trials – even for controversial policies. • Randomized evaluations of Medicaid waivers are feasible to implement. • Kentucky's waiver program included a community engagement requirement. • We designed a randomized trial to evaluate Kentucky's waiver program. • The design included a prospective, longitudinal survey and qualitative interviews. • The waiver was not implemented but our work serves as a model for policymakers. [ABSTRACT FROM AUTHOR]

The US lags behind >120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers. To investigate the "real-world" impact of GWLs in US smokers, we are conducting a randomized trial involving a 3-month intervention and 8-month follow-up. The study recruited California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1) Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack. Throughout the 3-month intervention, participants purchased study-packaged cigarettes and reported daily cognitions and behavior through ecological momentary assessments. We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up. The trial enrolled 359 participants (average age 39 years; average cigarette consumption half a pack/day). The 3 study groups were balanced on age, gender, race-ethnicity, education and income (17% low income) as well as on smoking related variables. This 3-month real-world randomized trial will test the effect of repackaging cigarettes from standard US packs to GWL plain packs on smokers' perceptions of the risks of smoking, their perception of the appeal of their cigarettes, and on their smoking behavior. • The efficacy of Graphic Warning Labels (GWLs) on Cigarette Packs has been disputed in US courts. • This trial randomly assigned US smokers to receive cigarettes in one of three study pack groups. • Study packs were:1-Blank Pack devoid of tobacco imagery; 2-GWL Pack; 3- Standard US pack. • We assessed smoking cognitions and behavior pre-randomization and during the intervention. • Smoking behavior is validated by saliva cotinine. [ABSTRACT FROM AUTHOR]

Emotionally distressed pregnant minority women experience multiple adverse outcomes, including pre-eclampsia, preterm birth, operative deliveries and low birth weight. Although the United States Preventive Services Task Force recommends screening in pregnant women, many practices do not screen because efficacious interventions and systems are not in place to treat them. Aim: Purpose of this randomized controlled trial (RCT) is to test a group delivered manualized cognitive-behavioral skills building intervention entitled COPE-P versus an attention control program on the mental health, birth and postpartum outcomes of minority pregnant women experiencing depressive, anxiety and stress symptoms. Methods: Design is a longitudinal randomized block RCT with repeated measures (beginning with screening prior to 18 weeks, group prenatal care in both groups from 16 + 1 to 31 + 1 weeks and ending at 6 months postpartum) at two study sites (New York city and Columbus, Ohio). Race/ethnicity is being blocked to ensure equal numbers of Hispanic and Black women. 384 women are being recruited from antenatal clinics if they are: between 18 and 40 years; in an uncomplicated singleton pregnancy <18 weeks; and self-identify as Black or Hispanic. Valid and reliable measures are being used to assess healthy lifestyle behaviors and mental health outcomes immediately following the interventions, six - eight weeks postpartum and at the children's six-month well baby visit. Birth and delivery outcomes also are being assessed. Conclusion: If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes. [ABSTRACT FROM AUTHOR]

Abstract: In traditional randomized controlled trial (RCT) designs, patients who are ineligible for randomization are excluded from study participation. However, these patients often constitute an important subgroup of the disease population. By extending existing RCT infrastructure, efforts to evaluate such patients in parallel cohort arms would provide an efficient means of generating multi-center prospective data on natural history, which would facilitate the development of future RCTs involving these subgroups of interest. This brief report discusses principles of the parallel-cohort RCT design, describes the few published trials in which it has been employed, and highlights novel aspects of its use in the Kids-DOTT trial—an ongoing multi-center randomized trial of the duration of anticoagulant therapy for venous thrombosis in children. [Copyright &y& Elsevier]

The optimal surveillance strategy for pancreatic cysts, which occur in up to 20% of the adult population, is ill defined. The risk of malignant degeneration of these cysts is low, however the morbidity and mortality associated with pancreatic cancer are high. Two clinical surveillance guidelines are in regular use. Both the Fukuoka and American Gastroenterological Association (AGA) guidelines rely on radiographic and endoscopic imaging. They differ primarily in their recommended frequencies of interval surveillance imaging. While evidence driven clinical guidelines should promote higher quality care, competing guidelines on the same topic may provide discordant recommendations and potential reduction in the quality and/or value of care. The primary objective is to compare the clinical effectiveness of the two surveillance guidelines to identify patients most likely to benefit from pancreatic resection. Secondary objectives include comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes. 4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance. All participants will be followed prospectively for 5 years. Differing guidelines confuse providers, patients and policymakers. This large, prospective, randomized trial will compare the clinical effectiveness and resource allocation requirements of two guidelines addressing a common clinical entity. NCT04239573. [ABSTRACT FROM AUTHOR]

Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss. Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity are randomized to participate in a standard weight management program alone or with their partner. The weight management program involves biweekly, in-person, group sessions focusing on weight loss for six months, followed by three group sessions and nine telephone calls focusing on weight loss maintenance for twelve months. In the partner-assisted arm, partners participate in half of the group sessions and telephone calls. Couples receive training in principles of cognitive behavioral therapy for couples, including sharing thoughts and feelings and joint problem solving, to increase communal coping. The primary outcome is participant weight loss at 24 months, with caloric intake and moderate-intensity physical activity as secondary outcomes. Partner weight and caloric intake will also be analyzed. Mediation analyses will examine the role of interdependence variables and social support. This trial will provide knowledge about effective ways to promote long-term weight loss and the role of interdependence constructs in weight loss. Clinical trials identifier : NCT 03801174. [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]

This article describes the protocol for a randomized effectiveness and cost-effectiveness trial of Stanley and Brown's Safety Planning Intervention (SPI) during pretrial jail detention to reduce post-release suicide events (suicide attempts, suicide behaviors, and suicide-related hospitalizations). With 10 million admissions per year and short stays (often days), U.S. jails touch many individuals at risk for suicide, providing an important opportunity for suicide prevention that is currently being missed. This study (N = 800) is the first randomized evaluation of an intervention to reduce suicide risk in the vulnerable year after jail release. Given that roughly 10% of all suicides in the U.S. with known circumstances occur in the context of a criminal legal stressor, reducing suicide risk in the year after arrest and jail detention could have a noticeable impact on national suicide rates. Pretrial jail detainees at risk for suicide were randomized to SPI during jail detention plus post-release phone follow-up or to enhanced Standard Care. Outcomes assessed through 12 months post-release include suicide events, suicide attempts, weeks of active suicide ideation, severity of suicide ideation, time to first event, psychiatric symptoms, functioning, and cost-effectiveness. Methods accommodate short jail stays and maximize trial safety and follow-up in a large sample with severe suicide risk, access to lethal means including substances and firearms, high rates of psychiatric illness, and unstable circumstances. Adequate funding was important to create the infrastructure needed to run this large trial cleanly. We encourage funders to provide adequate resources to ensure clean, well-run trials. [ABSTRACT FROM AUTHOR]

A small proportion of patients account for most of the healthcare costs. Previous studies of supportive interventions have several methodological limitations and results are mixed. This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov , NCT03628469). The main aim of the intervention is to reduce hospital admissions and improve quality of life at six months. A sample size of 4400 is needed and individuals with the highest risk of hospital admission in Denmark are invited by electronic communication and telephone to participate in a 1:1 randomized controlled trial. The intervention group receives one face-to-face start-up session followed by telephone sessions about individual goals regarding participants' knowledge, coping and need of healthcare. Quality of life was assessed with the mental health composite score of the SF-36v2 questionnaire. Primary analyses are done using the intention-to-treat principle. The trial has been approved by The Regional Committee on Health Research Ethics (SJ-677). Intervention nurses do not assume clinical responsibility for the participants and the intervention is an addition to the general healthcare services. The intervention is complex due to challenging skills and behaviors required by nurses, individual tailoring of the intervention, and interacting intervention components. The study therefore includes process evaluation. The research program comprises: 1. Development initiation, 2. Intervention effect, 3. Cost-effectiveness, 4. Organizational implementation, and 5. Participants' experiences. Inclusion to the trial began April 9th, 2018, was completed July 1st, 2019 and follow-up will be completed February 1st, 2020. [ABSTRACT FROM AUTHOR]

Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue. A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12–60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored. This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options. [ABSTRACT FROM AUTHOR]

Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors. Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older. Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months. If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs. [ABSTRACT FROM AUTHOR]

Diabetes prevalence has risen rapidly and has become a global health challenge. The Diabetes Prevention Program (DPP) has been shown to prevent or delay the development of diabetes among individuals with prediabetes. Yet, diabetes prevention studies within the Medicaid population are limited and results are mixed. This study aimed to evaluate the impact of different financial incentive strategies on the utilization of the DPP for Medicaid managed care adults in New York State. A four-arm randomized controlled trial was conducted among Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity. Study participants were offered a 16-week DPP with various incentive strategies based on class attendance and weight loss as follows: Attendance-Only, Weight-Loss Only, and both Attendance and Weight-Loss. A control group was offered DPP with no incentives for attendance or weight loss. We evaluated the impact of incentives on achievement of the program completion and weight-loss milestone. Participants who received incentives for the Attendance-Only class were least likely to be lost to follow-up, more likely to complete the program, and had two times higher percentage of meeting the weight-loss milestone compared to the control group. Results for the other incentive cohorts were mixed. A strong positive association was observed for participants who attended 9 or more classes and weight-loss regardless of incentive strategies. Providing monetary incentives for DPP class attendance had a positive impact on program completion and achieving the weight-loss milestone. However, the results from this study indicate that participant enrollment and retention remained challenges despite the incentives. [ABSTRACT FROM AUTHOR]

The OsteoArthritis and Therapy for Sleep (OATS) study is a population-based randomized controlled trial of cognitive behavioral therapy for insomnia (CBT I) with four innovative methodological aims. These are to: (1) Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3) Test a scalable CBT-I intervention; and (4) Evaluate patient-reported outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness over one year. This paper describes progress towards achieving these aims. The target population was persons age 60+ who had received OA care within the Kaiser Permanente Washington (KPW) health care system. We employed a two-phase screening via mail survey and telephone follow-up, with a 3-week interval between screens to exclude persons with spontaneous improvement in sleep or pain symptoms. Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC). Blinded outcome assessments (completed online or on mailed paper forms) included primary and secondary sleep and pain outcome measures and quality of life measures. We obtained healthcare utilization from administrative claims data. Intent to treat analyses, including all participants randomized when they scheduled the first telephone session, will be conducted to compare CBT-I and EOC outcomes. The trial will be the largest experimental evaluation of telephone CBT-I to date, and the first to evaluate its cost-effectiveness. Trial registration: Clinical Trials.gov identifier: NCT02946957. [ABSTRACT FROM AUTHOR]

Although the current smoking prevalence among Hispanics/Latinxs (10%) is lower than in non-Hispanic whites (15%), higher prevalence is observed among certain subgroups (e.g., Puerto Rican males, 19%). Hispanic/Latinx smokers face unique challenges such as lower awareness and acceptability of nicotine replacement aids, lower prevalence of using counseling or medication, and receiving less advice to quit by their health care providers. Despite these barriers to smoking cessation, few interventions specifically targeted to Hispanic/Latinx smokers have been developed and evaluated. This paper summarizes the design, methods, analysis plan, and sample baseline characteristics of an ongoing randomized controlled trial to assess the efficacy of a Spanish-language self-help smoking cessation intervention among Hispanics/Latinxs. Current smokers who prefer health education materials in Spanish were randomized to one of two conditions. The usual care group received a standard smoking cessation booklet developed by the National Cancer Institute. The intervention group received 10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18 months. All participants complete self-report surveys every 6 months over 2 years. Smoking abstinence is biochemically verified at 12- and 24-month follow-up. A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study. The primary outcome is self-reported 7-day point prevalence abstinence. If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population. [ABSTRACT FROM AUTHOR]

Multiple national organizations and leaders have called for increased attention to dementia prevention in those most vulnerable, for example persons with limited formal education. Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve. Test feasibility, treatment modifier, mechanism, and cognitive function effects of a multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods) to target neurobiological health, and speed of processing training to enhance cognitive reserve. We refer to this multicomponent intervention as MINDSpeed. MINDSpeed is being evaluated in a 2 × 2 randomized factorial design with 180 participants residing independently in a large Midwestern city. Qualifying participants are 60 years of age or older with no evidence of dementia, and who have completed 12 years or less of education. All participants receive a study-issued iPad to access the custom study application that enables participants, depending on randomization, to select either control or MIND food, and to play online cognitive games, either speed of processing or control games. All participants complete informed consent and baseline assessment, including urine and blood samples. Additionally, up to 90 participants will complete neuroimaging. Assessments are repeated immediately following 12 weeks of active intervention, and at 24 weeks post-randomization. The primary outcome is an executive cognitive composite score. Secondary outcomes include oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions. MINDSpeed is the first study to evaluate the multicomponent intervention of high polyphenol intake and speed of processing training. It is also one of the first dementia prevention trials to target older adults with low education. The results of the study will guide future dementia prevention efforts and trials in high risk populations. [ABSTRACT FROM AUTHOR]