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BackgroundVeterans with post-traumatic stress disorder (PTSD) are more likely to report chronic pain than veterans without PTSD. Yoga has been shown to reduce both chronic pain and PTSD symptoms in clinical trials. The goal of our study was to assess the feasibility and acceptability of conducting a randomized controlled trial (RCT) that combined yoga and mantram repetition (Yoga + MR) into one program for military veterans with both chronic pain and PTSD.MethodsIn this feasibility RCT, 27 veterans were randomized to either Yoga + MR or a relaxation intervention. Due to the COVID-19 pandemic, in-person recruitment, assessments, and intervention attendance were re-evaluated. Although remote delivery of aspects of the study were utilized, interventions were delivered in-person. Feasibility benchmarks met included full recruitment in 12 months or less, 75%+ retention at initial follow-up assessment, 50%+ attendance rate, and 75%+ of participants satisfied with the interventions.ResultsThe sample was racially and ethnically diverse, and 15% of participants were women. Participant recruitment lasted approximately 11 months. Out of 32 participants initially randomized, two participants asked to be dropped from the study and three did not meet PTSD symptom criteria. For the remaining 27 participants, retention rates were 85% at 12 weeks and 81% at 18 weeks. Participants attended 66% of in-person yoga and 55% of in-person relaxation sessions. Satisfaction was high, with 100% of yoga participants and 75%/88% of relaxation participants agreeing or strongly agreeing they were satisfied with the intervention/instructors. After 12 weeks (end of intervention), Yoga + MR participants reported reduced back-pain related disability (primary outcome), reduced alcohol use, reduced fatigue, and increased quality of life, while relaxation group participants reported reductions in pain severity, PTSD symptoms, and fatigue.ConclusionsAmidst many research challenges during the pandemic, recruitment, retention, and efficacy results from this feasibility trial support advancement to a larger RCT to study Yoga + MR for chronic pain and PTSD.

BackgroundChronic low back pain (cLBP) and chronic neck pain (cNP) are highly prevalent conditions and common reasons for disability among military personnel. Yoga and other mind-body interventions have been shown to safely decrease pain and disability in persons with cLBP and/or cNP but have not been adequately studied in active duty military personnel. The objective of this study was to examine the feasibility and acceptability of delivering 2 types of yoga (hatha and restorative) to a sample of active-duty military personnel with cLBP/cNP.MethodsMilitary personnel with cLBP and/or cNP (n = 49; 59% men) were randomized to either hatha or restorative yoga interventions. Interventions consisted of in-person yoga 1-2x weekly for 12 weeks. Feasibility and acceptability were measured by rates of recruitment, intervention attendance, attrition, adverse events, and satisfaction ratings. Health outcomes including pain and disability were measured at baseline, 12 weeks, and 6 months. Means and effect sizes are presented.ResultsRecruitment was completed ahead of projections. Over 90% of participants agreed or strongly agreed that they enjoyed participation, liked the instructor, and would like to continue yoga. Retention rates were 86% and 80% at 12 week and 6 month assessments, respectively. Intervention attendance was adequate but lower than expected. There were small to moderate reductions in back-pain related disability, pain severity and pain interference, and improvements in quality of life, grip strength, and balance. In general, effects were larger for those who attended at least 50% of intervention classes. Participants with cNP tended to have smaller outcome improvements, but conclusions remain tentative given small sample sizes.ConclusionsResults demonstrate feasibility for conducting a randomized controlled comparative effectiveness trial of yoga for cLBP and cNP among active duty military personnel. Acceptability was also established. Ongoing work will enhance the intervention for cNP and establish feasibility at another military facility in preparation for a fully-powered comparative effectiveness trial.ClinicalTrials #NCT03504085; registered April 20, 2018.

Previous studies measuring the health-related quality of life (HRQoL) of individuals with dengue focused on treatment seeking populations. However, the vast majority of global dengue cases are unlikely to be detected by health systems. Representative measurements of HRQoL should therefore include patients with disease not likely to trigger treatment-seeking behavior. This study based in Iquitos, Peru used the Quality of Wellbeing Scale-Self Administered, a survey that enquires about not only physical health, but also psychological health, self-care, mobility, and usual social activities, and rates HRQoL between 0 (death) and 1 (optimum function), to evaluate the impact of dengue on HRQoL. In order to enroll treatment and non treatment-seeking participants, three modalities of participant recruitment were used. In addition to clinic and community-based febrile surveillance, a contact-cluster methodology was also employed to identify infected individuals less likely to seek treatment. We measured changes in HRQoL and identified common areas of health impairment in 73 virologically confirmed dengue cases at 3 time points during the participant's illness; the early-acute (days 0-6 post symptom onset), late-acute (days 7-20), and convalescent illness phases (days 21 +). Participants reported HRQoL related impairments at significantly higher frequency during the early-acute versus convalescent illness phase (Fisher's exact: P

Chronic low-back pain (cLBP) is a prevalent condition, and rates are higher among military veterans. cLBP is a persistent condition, and treatment options have either modest effects or a significant risk of side-effects, which has led to recent efforts to explore mind-body intervention options and reduce opioid medication use. Prior studies of yoga for cLBP in community samples, and the main results of a recent trial with military veterans, indicate that yoga can reduce back-related disability and pain intensity. Secondary outcomes from the trial of yoga with military veterans are presented here. In the study, 150 military veterans (Veterans Administration patients) with cLBP were randomized to either yoga or a delayed-treatment group receiving usual care between 2013 and 2015. Assessments occurred at baseline, 6 weeks, 12 weeks, and 6 months. Intent-to-treat analyses were conducted. Yoga classes lasting 60 minutes each were offered twice weekly for 12 weeks. Yoga sessions consisted of physical postures, movement, focused attention, and breathing techniques. Home practice guided by a manual was strongly recommended. The primary outcome measure was Roland-Morris Disability Questionnaire scores after 12 weeks. Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage. Yoga participants improved more than delayed-treatment participants on pain interference, fatigue, quality of life, and self-efficacy at 12 weeks and/or 6 months. Yoga participants had greater improvements across a number of important secondary health outcomes compared to controls. Benefits emerged despite some veterans facing challenges with attending yoga sessions in person. The findings support wider implementation of yoga programs for veterans, with attention to increasing accessibility of yoga programs in this population.

INTRODUCTION:Older adults are a rapidly growing segment of the U.S. POPULATION:Mobility problems that lead to further disability can be addressed through physical activity interventions. Quality of life outcome results are reported from a large trial of physical activity for sedentary older adults at risk for mobility disability. METHODS:Data were from the Lifestyle Interventions and Independence for Elders study. This multisite RCT compared physical activity to health education among 1,635 randomly assigned sedentary older adults at risk for mobility disability in 2010-2011. Measures included demographics; comorbidity; a timed 400-meter walk; the Short Physical Performance Battery; and the Quality of Well-Being Scale (0-1.0 scale). Baseline and long-term follow-up (2.6 years) health-related quality of life data were collected as a secondary outcome. Multivariate linear regression modeling was used to examine covariates of health-related quality of life over time in 2017. RESULTS:The sample had an overall mean Quality of Well-Being score of 0.613. Both groups declined in quality of life over time, but assignment to the physical activity intervention resulted in a slower decline in health-related quality of life scores (p=0.03). Intervention attendance was associated with higher health-related quality of life for both groups. Baseline characteristics including younger age, fewer comorbid conditions, non-white ethnicity, and faster 400-meter walk times were also associated with higher health-related quality of life over time. CONCLUSIONS:Declining mobility measured by physical performance is associated with lower quality of life in sedentary older adults. Physical activity interventions can slow the decline in quality of life, and targeting specific subgroups may enhance the effects of such interventions.

BackgroundThe loss of mobility during aging impacts independence and leads to further disability, morbidity, and reduced life expectancy. Our objective was to examine the feasibility and safety of conducting a randomized controlled trial of yoga for older adults at risk for mobility limitations.MethodsSedentary older adults (n = 46; age 60-89) were recruited and randomized to either yoga or a health education comparison group. Yoga sessions (60-min) occurred 2x weekly, and 90-min health education sessions occurred weekly, for 10 weeks. The primary outcomes were recruitment rate, intervention attendance, and retention at assessments. Adverse event rates and participant satisfaction were also measured. Physical performance measures of gait, balance, and strength and self-report outcome measures were administered at baseline and 10-weeks.ResultsRecruitment lasted 6 months. Retention of participants at the 10-week follow-up was high (89% - performance measures; 98% - self-report questionnaires). Attendance was good with 82% of yoga and 74% of health education participants attending at least 50% of the sessions. No serious adverse events were reported. Patient satisfaction with the interventions was high. The mean effect size for the physical performance measures was 0.35 with some over 0.50. The mean effect size for self-report outcome measures was 0.36.ConclusionsResults indicate that it is feasible to conduct a larger RCT of yoga for sedentary older adults at risk for mobility problems. The yoga and comparison interventions were safe, well accepted, and well attended. Effect sizes suggest yoga may have important benefits for this population and should be studied further.Trial registrationClinicalTrials # NCT03544879 ; Retrospectively registered 4 June, 2018.

BackgroundGrowth-based drug susceptibility testing (DST) is the reference standard for diagnosing drug-resistant tuberculosis (TB), but standard time to result (TTR) is typically ≥ 3 weeks. Rapid tests can reduce that TTR to days or hours, but accuracy may be lowered. In addition to the TTR and test accuracy, the cost of a diagnostic test may affect whether it is adopted in clinical settings. We examine the cost-effectiveness of rapid diagnostics for extremely drug-resistant TB (XDR-TB) in three different high-prevalence settings.Methods1128 patients with confirmed TB were enrolled at clinics in Mumbai, India; Chisinau, Moldova; and Port Elizabeth, South Africa. Patient sputum samples underwent DST for first and second line TB drugs using 2 growth-based (MGIT, MODS) and 2 molecular (Pyrosequencing [PSQ], line-probe assays [LPA]) assays. TTR was the primary measure of effectiveness. Sensitivity and specificity were also evaluated. The cost to perform each test at each site was recorded and included test-specific materials, personnel, and equipment costs. Incremental cost-effectiveness ratios were calculated in terms of $/day saved. Sensitivity analyses examine the impact of batch size, equipment, and personnel costs.ResultsOur prior results indicated that the LPA and PSQ returned results in a little over 1 day. Mean cost per sample without equipment or overhead was $23, $28, $33, and $41 for the MODS, MGIT, PSQ, and LPA, respectively. For diagnosing XDR-TB, MODS was the most accurate, followed by PSQ, and LPA. MODS was quicker and less costly than MGIT. PSQ and LPA were considerably faster but cost more than MODS. Batch size and personnel costs were the main drivers of cost variation.ConclusionsMultiple factors must be weighed when selecting a test for diagnosis of XDR-TB. Rapid tests can greatly improve the time required to diagnose drug-resistant TB, potentially improving treatment success, and preventing the spread of XDR-TB. Faster time to result must be weighed against the potential for reduced accuracy, and increased costs.Trial registrationClinicalTrials.gov Identifier: NCT02170441 .

ObjectiveMillions of military personnel and veterans live with chronic mental and physical health conditions that often do not respond well to pharmacological treatments. Serious side effects and lack of treatment response have led to widespread efforts to study and promote non-pharmacological and behavioral health treatments for many chronic health conditions. Yoga is an increasingly popular mind-body intervention that has growing research support for its efficacy and safety. Our objective was to explore the attitudes, perspectives, and preferences of military personnel and veterans toward yoga as a therapeutic modality, thus providing needed information for designing and promoting yoga interventions for this population.MethodsParticipants included 24 individuals with yoga experience and current or past military service and 12 instructors who have taught yoga for military personnel and/or veterans. A semi-structured set of questions guided interviews with each participant.ResultsFive themes emerged from the interviews: (1) mental health benefits experienced from yoga practice; (2) physical health benefits experienced from yoga practice; (3) important yoga elements and conditions that support effective practice; (4) facilitators for engaging military in yoga practice; and (5) challenges and barriers to yoga practice for military.ConclusionsThe study highlights consistent reports of mental and physical benefits of yoga practice, ongoing stigma resulting in the need for combatting and demystifying yoga and other complementary and integrative health (CIH) practices, the importance of designing interventions to address the unique mental health issues and perspectives of this population, and the importance of efforts by military leadership to bring CIH to military personnel and veterans. Rigorous research addressing these findings, along with further research on the efficacy and effectiveness of yoga interventions for treating various conditions are needed.

IntroductionChronic low back pain (cLBP) is prevalent, especially among military veterans. Many cLBP treatment options have limited benefits and are accompanied by side effects. Major efforts to reduce opioid use and embrace nonpharmacological pain treatments have resulted. Research with community cLBP patients indicates that yoga can improve health outcomes and has few side effects. The benefits of yoga among military veterans were examined.DesignParticipants were randomized to either yoga or delayed yoga treatment in 2013-2015. Outcomes were assessed at baseline, 6 weeks, 12 weeks, and 6 months. Intention-to-treat analyses occurred in 2016.Setting/participantsOne hundred and fifty military veterans with cLBP were recruited from a major Veterans Affairs Medical Center in California.InterventionYoga classes (with home practice) were led by a certified instructor twice weekly for 12 weeks, and consisted primarily of physical postures, movement, and breathing techniques.Main outcome measuresThe primary outcome was Roland-Morris Disability Questionnaire scores after 12 weeks. Pain intensity was identified as an important secondary outcome.ResultsParticipant characteristics were mean age 53 years, 26% were female, 35% were unemployed or disabled, and mean back pain duration was 15 years. Improvements in Roland-Morris Disability Questionnaire scores did not differ between the two groups at 12 weeks, but yoga participants had greater reductions in Roland-Morris Disability Questionnaire scores than delayed treatment participants at 6 months -2.48 (95% CI= -4.08, -0.87). Yoga participants improved more on pain intensity at 12 weeks and at 6 months. Opioid medication use declined among all participants, but group differences were not found.ConclusionsYoga improved health outcomes among veterans despite evidence they had fewer resources, worse health, and more challenges attending yoga sessions than community samples studied previously. The magnitude of pain intensity decline was small, but occurred in the context of reduced opioid use. The findings support wider implementation of yoga programs for veterans.Trial registrationThis study is registered at www.clinicaltrials.gov NCT02524158.

ObjectivesTo examine prospective associations between changes in physical activity (PA) and changes in physical performance measures (PPMs) over 6 years in older women.DesignProspective cohort study.SettingForty clinical centers in the United States.ParticipantsWomen aged 65 and older (mean age 69.8) enrolled in the Women's Health Initiative Clinical Trials with gait speed, timed chair stand, grip strength, and self-reported recreational PA data assessed at baseline (1993-98) and follow-up Years 1, 3, and 6 (N = 5,092).MeasurementsMixed-effects linear regression models were used to determine the association between time-varying PA and change in each PPM. Potential interactions between time-varying PA and age (

Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2× weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans.

BackgroundLosing the ability to walk safely and independently is a major concern for many older adults. The Lifestyle Interventions and Independence for Elders study recently demonstrated that a physical activity (PA) intervention can delay the onset of major mobility disability. Our objective is to examine the resources required to deliver the PA intervention and calculate the incremental cost-effectiveness compared with a health education intervention.MethodsThe Lifestyle Interventions and Independence for Elders study enrolled 1,635 older adults at risk for mobility disability. They were recruited at eight field centers and randomly assigned to either PA or health education. The PA program consisted of 50-minute center-based exercise 2× weekly, augmented with home-based activity to achieve a goal of 150 min/wk of PA. Health education consisted of weekly workshops for 26 weeks, and monthly sessions thereafter. Analyses were conducted from a health system perspective, with a 2.6-year time horizon.ResultsThe average cost per participant over 2.6 years was US$3,302 and US$1,001 for the PA and health education interventions, respectively. PA participants accrued 0.047 per person more Quality-Adjusted Life-Years (QALYs) than health education participants. PA interventions costs were slightly higher than other recent PA interventions. The incremental cost-effectiveness ratios were US$42,376/major mobility disability prevented and US$49,167/QALY. Sensitivity analyses indicated that results were relatively robust to varied assumptions.ConclusionsThe PA intervention costs and QALYs gained are comparable to those found in other studies. The ICERS are less than many commonly recommended medical treatments. Implementing the intervention in non-research settings may reduce costs further.

Purpose of the studyTrajectories of physical activity (PA) and sedentary time (ST) after military separation are likely important determinants of women's health outcomes later in life, because low PA and high ST are known contributors to premature mortality risk. Our objective was to compare longitudinal trajectories of recreational PA and ST between Veteran and non-Veteran postmenopausal women from the Women's Health Initiative (WHI).Design and methodsWomen Veteran (n = 3,719) and non-Veteran (n = 141,800) WHI participants were included. Self-reported participation in recreational PA, converted to metabolic equivalent (MET)-hours/week, was prospectively assessed over 8 years. Self-reported ST, defined as hours/day sitting or lying down, was collected at baseline and at Years 3 and 6. Generalized estimating equations were used to compare trajectories of PA and ST between Veterans and non-Veterans, adjusted for demographics and lifestyle behaviors.ResultsVeterans had higher baseline PA than non-Veterans (13.2 vs 12.5 MET-hours/week, p = .03). PA declined for both groups, with a steeper decline among Veterans (change/visit year -0.19 vs -0.02 MET-hours/week; interaction p < .001). At baseline, Veterans and non-Veterans had similar levels of ST (107.2 vs 105.9 hours/week, p = 0.42). Over time, ST remained stable among Veterans but declined slightly among non-Veterans (change/visit year -0.19 vs -0.49 hours/week; interaction p = .01).ImplicationsThe less favorable longitudinal trajectories of PA and ST we observed for women Veterans may contribute to worse health among these individuals later in life. Understanding barriers to enhancing PA and reducing ST in women Veterans could lead to more effective approaches to intervening on these health behaviors.

ObjectivesChronic low back pain (CLBP) affects millions of people worldwide, and appears to be increasing in prevalence. It is associated not only with pain, but also with increased disability, psychological symptoms, and reduced quality of life. There are various treatment options for CLBP, but no single therapy stands out as being the most effective. In the past 10 years, yoga interventions have been studied as a CLBP treatment approach. The objective of this paper is to review the current literature supporting the efficacy of yoga for CLBP.MethodsA literature search through the beginning of 2015 was conducted in Pub Med for randomized control trials addressing treatment of CLBP with yoga.ResultsIn this review we evaluate the use of yoga as a treatment for CLBP. Specifically we evaluate how yoga impacts physical functioning and disability, pain, and associated psychological symptoms. We also evaluate possible mediators of the effect of yoga and the safety of yoga.DiscussionWith few exceptions, previous studies and the recent randomized control trials (RCTs) indicate that yoga can reduce pain and disability, can be practiced safely, and is well received by participants. Some studies also indicate that yoga may improve psychological symptoms, but these effects are currently not as well established.

Background. Higher coffee consumption has been associated with decreased incidence of colorectal cancer. Our objective was to examine the relationship of coffee intake to colorectal cancer incidence in a large observational cohort of postmenopausal US women. Methods. Data were collected for the Women's Health Initiative Observational Study providing a follow-up period of 12.9 years. The mean age of our sample (N = 83,778 women) was 63.5 years. Daily coffee intake was grouped into 3 categories: None, moderate (>0-

BackgroundThe aim of this study was to compare the performance of several recently developed assays for the detection of multi- and extensively drug-resistant tuberculosis (M/XDR-TB) in a large, multinational field trial.MethodsSamples from 1,128 M/XDR-TB suspects were examined by Line Probe Assay (LPA), Pyrosequencing (PSQ), and Microscopic Observation of Drug Susceptibility (MODS) and compared to the BACTEC MGIT960 reference standard to detect M/XDR-TB directly from patient sputum samples collected at TB clinics in India, Moldova, and South Africa.ResultsSpecificity for all three assays was excellent: 97-100% for isoniazid (INH), rifampin (RIF), moxifloxacin (MOX) and ofloxacin (OFX) and 99-100% for amikacin (AMK), capreomycin (CAP) and kanamycin (KAN) resistance. Sensitivities were lower, but still very good: 94-100% for INH, RIF, MOX and OFX, and 84-90% for AMK and CAP, but only 48-62% for KAN. In terms of agreement, statistically significant differences were only found for detection of RIF (MODS outperformed PSQ) and KAN (MODS outperformed LPA and PSQ) resistance. Mean time-to-result was 1.1 days for LPA and PSQ, 14.3 days for MODS, and 24.7 days for MGIT.ConclusionsAll three rapid assays evaluated provide clinicians with timely detection of resistance to the drugs tested; with molecular results available one day following laboratory receipt of samples. In particular, the very high specificity seen for detection of drug resistance means that clinicians can use the results of these rapid tests to avoid the use of toxic drugs to which the infecting organism is resistant and develop treatment regiments that have a higher likelihood of yielding a successful outcome.

BackgroundDrug-resistant tuberculosis (DR-TB) remains a threat to global public health, owing to the complexity and delay of diagnosis and treatment. The Global Consortium for Drug-resistant Tuberculosis Diagnostics (GCDD) was formed to develop and evaluate assays designed to rapidly detect DR-TB, so that appropriate treatment might begin more quickly. This paper describes the methodology employed in a prospective cohort study for head-to-head assessment of three different rapid diagnostic tools.MethodsSubjects at risk of DR-TB were enrolled from three countries. Data were gathered from a combination of patient interviews, chart reviews, and laboratory testing from each site's reference laboratory. The primary outcome of interest was reduction in time from specimen arrival in the laboratory to results of rapid drug susceptibility tests, as compared with current standard mycobacterial growth indicator tube (MGIT) drug susceptibility tests.ResultsSuccessful implementation of the trial in diverse multinational populations is explained, in addition to challenges encountered and recommendations for future studies with similar aims or populations.ConclusionsThe GCDD study was a head-to-head study of multiple rapid diagnostic assays aimed at improving accuracy and precision of diagnostics and reducing overall time to detection of DR-TB. By conducting a large prospective study, which captured epidemiological, clinical, and biological data, we have produced a high-quality unique dataset, which will be beneficial for analyzing study aims as well as answering future DR-TB research questions. Reduction in detection time for XDR-TB would be a major public health success as it would allow for improved treatment and more successful patient outcomes. Executing successful trials is critical in assessment of these reductions in highly variable populations.Trial registrationClinicalTrials.gov NCT02170441.

OBJECTIVE: Diabetes is associated with reduced health-related quality of life (HRQoL). Information on the relationship between HRQoL and glucose-lowering medications in recently diagnosed type 2 diabetes (T2D) is limited. We assessed changes in HRQoL in participants with T2D receiving metformin plus one of four glucose-lowering medications in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). RESEARCH DESIGN AND METHODS: A total of 5,047 participants, baseline mean age 57 years, with <10 years T2D duration and glycated hemoglobin level 6.8–8.5% and taking metformin monotherapy, were randomly assigned to glargine, glimepiride, liraglutide, or sitagliptin. HRQoL was evaluated at baseline for 4,885 participants, and at years 1, 2, and 3, with use of the self-administered version of the Quality of Well-being Scale (QWB-SA) and SF-36 physical (PCS) and mental (MCS) component summary scales. Linear models were used to analyze changes in HRQoL over time in intention-to-treat analyses. RESULTS: None of the medications worsened HRQoL. There were no differences in QWB-SA or MCS by treatment group at any time point. PCS scores improved with liraglutide versus other groups at year 1 only. Greater weight loss during year 1 explained half the improvement in PCS scores with liraglutide versus glargine and glimepiride. Liraglutide participants in the upper tertile of baseline BMI showed the greatest improvement in PCS scores at year 1. CONCLUSIONS: Adding liraglutide to metformin in participants within 10 years of T2D diagnosis showed improvement in the SF-36 PCS in comparisons with the other medications at 1 year, which was no longer significant at years 2 and 3. Improvement was related to weight loss and baseline BMI. [ABSTRACT FROM AUTHOR]

Background. Despite the emergence of new hepatitis C virus (HCV) antiviral medications, many people with chronic HCV know little about their disease, are at risk for transmitting HCV to others, and/or are not considered good treatment candidates. Self-management interventions can educate HCV-infected persons, improve their quality of life, and prepare them for treatment. Purpose. A cost-effectiveness analysis of the HCV Self-Management Program is presented. Method. Effectiveness data in quality-adjusted life years (QALYs) were derived from the previously published prospective, randomized controlled trial (n = 134). Health care utilization was abstracted from medical records in 2011 for the 12 months before and after study enrollment. Intervention costs were tracked from the payer's perspective and combined with health care costs. Sensitivity analyses were used to examine assumptions. Data were analyzed in 2014. Results. Estimated intervention costs including organizational overhead were $1,760 per 6-week workshop, or $229/person. Health care costs were $815 lower/person for self-management participants, resulting in a cost savings of $586/person. Self-management participants had an average net gain of 0.02975 QALYs after 1 year. When removing inpatient substance use treatment days from analyses, costs were similar between groups, producing an incremental cost-effectiveness ratio of $6,218/QALY. Sensitivity analyses showed that the results and conclusions change little when assumptions were varied. Conclusions. When compared to information-only, the HCV Self-Management Program led to more QALYs and cost savings in the randomized controlled trial. Independent of health care costs, the intervention is low-cost and educates HCV-infected individuals about antiviral treatment and avoiding viral transmission. Low-cost interventions that can enhance the outcomes derived from expensive antiviral treatments should be studied further.

Abstract Background Colorectal cancer (CRC) screening rates are low in many areas and cost-effective interventions to promote CRC screening are needed. Recently in a randomized controlled trial, a mailed educational reminder increased CRC screening rates by 16.2% among U.S. Veterans. The aim of our study was to assess the costs and cost-effectiveness of a mailed educational reminder on fecal occult blood test (FOBT) adherence. Methods In a blinded, randomized, controlled trial, 769 patients were randomly assigned to the usual care group (FOBT alone, n = 382) or the intervention group (FOBT plus a mailed reminder, n = 387). Ten days after picking up the FOBT cards, a 1-page reminder with information related to CRC screening was mailed to the intervention group. Primary outcome was number of returned FOBT cards after 6 months. The costs and incremental cost-effectiveness ratio (ICER) of the intervention were assessed and calculated respectively. Sensitivity analyses were based on varying costs of labor and supplies. Results At 6 months after card distribution, 64.6% patients in the intervention group returned FOBT cards compared with 48.4% in the control group (P < 0.001). The total cost of the intervention was $962 or $2.49 per patient, and the ICER was $15 per additional person screened for CRC. Sensitivity analysis based on a 10% cost variation was $13.50 to $16.50 per additional patient screened for CRC. Conclusions A simple mailed educational reminder increases FOBT card return rate at a cost many health care systems can afford. Compared to other patient-directed interventions (telephone, letters from physicians, mailed reminders) for CRC screening, our intervention was more effective and cost-effective.

Social health is important to measure when assessing outcomes in community mental health. Our objective was to validate social health scales using items from two broader commonly used measures that assess mental health outcomes. Participants were 609 adults receiving psychological treatment services. Items were identified from the California Quality of Life (CA-QOL) and Mental Health Statistics Improvement Program (MHSIP) outcome measures by their conceptual correspondence with social health and compared to the Social Functioning Questionnaire (SFQ) using correlational analyses. Pearson correlations for the identified CA-QOL and MSHIP items with the SFQ ranged from .42 to .62, and the identified scale scores produced Pearson correlation coefficients of .56, .70, and, .70 with the SFQ. Concurrent validity with social health was supported for the identified scales. The current inclusion of these assessment tools allows community mental health programs to include social health in their assessments.

Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths in the United States. Randomized controlled trials have shown that annual screening fecal occult blood testing (FOBT) reduces CRC mortality and incidence. However, patient compliance with FOBT is low.To determine whether a mailed educational reminder increases FOBT card return rates and to examine predictors of FOBT compliance.Blinded, randomized, controlled trial at the Veteran Affairs Medical Center, San Diego, California.Seven hundred and seventy-five consecutive patients ≥50 years of age referred by their primary care physicians for FOBT.Patients were randomly assigned to the usual care group or the intervention group. Ten days after picking up the FOBT cards, a 1-page reminder with information related to CRC screening was mailed to the intervention group only.The primary outcome was proportion of returned FOBT cards after 6 months. Patient demographic, clinical characteristics and prior FOBT completed were collected for multivariate regression analysis.At 6 months after card distribution, 64.6% of patients in the intervention group returned cards compared with 48.4% in the control group (P

Background: Veterans with post-traumatic stress disorder (PTSD) are more likely to report chronic pain than veterans without PTSD. Yoga has been shown to reduce both chronic pain and PTSD symptoms in clinical trials. The goal of our study was to assess the feasibility and acceptability of conducting a randomized controlled trial (RCT) that combined yoga and mantram repetition (Yoga + MR) into one program for military veterans with both chronic pain and PTSD. Methods: In this feasibility RCT, 27 veterans were randomized to either Yoga + MR or a relaxation intervention. Due to the COVID-19 pandemic, in-person recruitment, assessments, and intervention attendance were re-evaluated. Although remote delivery of aspects of the study were utilized, interventions were delivered in-person. Feasibility benchmarks met included full recruitment in 12 months or less, 75%+ retention at initial follow-up assessment, 50%+ attendance rate, and 75%+ of participants satisfied with the interventions. Results: The sample was racially and ethnically diverse, and 15% of participants were women. Participant recruitment lasted approximately 11 months. Out of 32 participants initially randomized, two participants asked to be dropped from the study and three did not meet PTSD symptom criteria. For the remaining 27 participants, retention rates were 85% at 12 weeks and 81% at 18 weeks. Participants attended 66% of in-person yoga and 55% of in-person relaxation sessions. Satisfaction was high, with 100% of yoga participants and 75%/88% of relaxation participants agreeing or strongly agreeing they were satisfied with the intervention/instructors. After 12 weeks (end of intervention), Yoga + MR participants reported reduced back-pain related disability (primary outcome), reduced alcohol use, reduced fatigue, and increased quality of life, while relaxation group participants reported reductions in pain severity, PTSD symptoms, and fatigue. Conclusions: Amidst many research challenges during the pandemic, recruitment, retention, and efficacy results from this feasibility trial support advancement to a larger RCT to study Yoga + MR for chronic pain and PTSD. [ABSTRACT FROM AUTHOR]