Search

Erik J Groessl,1,2 Steven R Tally,1 Naomi Hillery1 1Health Services Research Center, Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, CA, USA; 2VA San Diego Healthcare System, San Diego, CA, USACorrespondence: Erik J Groessl, University of California San Diego, Health Services Research Center, 9500 Gilman Drive, Mail Code 0994, San Diego, CA, 92037, USA, Tel +1 858 622 1771, Email egroessl@health.ucsd.eduPurpose: Chronic obstructive pulmonary disease (COPD) is the third leading cause of mortality, and is associated with significant respiratory impairment, decreased quality of life, and high health care costs. Recent evidence indicates significant clinical benefit results from adding humidified high-flow therapy (HHFT) to standard long-term oxygen therapy (LTOT) as a home-based therapy in persons with severe COPD. The objective was to evaluate the cost-effectiveness of adding HHFT to standard treatment of COPD patients using LTOT with US healthcare cost estimates.Patients and Methods: A Markov state-transition model was developed using data from a prospective clinical trial of adding HHFT to standard therapy for persons with severe COPD using LTOT. The analysis was conducted from the US health care system perspective using a 5-year time horizon and 3% discount rate. QALYs and downstream healthcare costs were modeled. One-way and probabilistic sensitivity analyses were used to examine the impact of input parameters on the incremental net monetary benefit (NMB).Results: Incremental QALYs accrued were 0.058 (2.047 vs 1.989 QALYs for HHFT and standard therapy groups respectively). Incremental total costs were -$3939 ($47,516 vs $51,455 for HHFT and standard therapy groups respectively). Thus, HHFT was the dominant treatment in the analysis, resulting on both better health and lower total costs. Varying utility and cost inputs individually never resulted in NMB approaching 0. Probabilistic analyses indicate that HHFT is cost-effective in 84% of simulations.Conclusion: Our results indicate that the reductions in acute exacerbations of COPD (AECOPDs) that result from adding HHFT for persons with COPD on LTOT will produce both health benefit (QALYs) and cost savings. Cost savings occur because the HHFT device costs are more than offset by reductions in costly COPD exacerbations. Health care systems and payors can benefit from wider implementation of HHFT with existing treatments.Keywords: COPD, acute exacerbations, cost-effectiveness, humidified high flow therapy

Latinas report low levels of physical activity (PA) and disproportionate risk of lifestyle-related diseases. Enhancements to evidence-based PA interventions may increase efficacy; however, uptake of interventions will likely depend on costs. To describe costs and examine the cost-effectiveness of two interventions for helping Latinas reach national aerobic PA guidelines. Adult Latinas (N = 199) were randomly assigned to an Original theory-based mail-delivered intervention or an Enhanced version with texting and additional calls and materials. Meeting PA guidelines was measured by the 7-Day PA Recall interview at baseline, 6 and 12 months. Intervention costs were estimated from a payer perspective. Incremental cost-effectiveness ratios (ICERs) were calculated as the additional cost per participant meeting guidelines in the Enhanced versus Original intervention. At baseline, no participants met guidelines. After 6 months, 57% and 44% in the Enhanced and Original arms met guidelines, respectively; at 12 months, rates fell to 46% and 36%. Cost per person of the Enhanced and Original interventions were $184 and $173 at 6 months, respectively, and $234 and $203 at 12 months. The primary additional expense in the Enhanced arm was staff time. ICERs were $87 per additional person meeting guidelines at 6 months (per sensitivity analysis, $26 if delivered by volunteers and $114 by medical assistants), and $317 at 12 months (sensitivity analysis: $57 and $434). Incremental costs per person meeting guidelines in the Enhanced arm were modest and could be warranted given the potential health benefits of meeting PA guidelines.

Table S1. Hazard ratios (HR) and 95% confidence intervals (95% CI) for the association between metabolic phenotype with varied definitions and colorectal/colon cancer among normal-weight women. Table S2. Hazard ratios (HR) and 95% confidence intervals (95% CI) for the association between metabolic phenotype and colorectal/colon cancer among normal-weight women without diabetes. Table S3. Hazard ratios (HR) and 95% confidence intervals (95% CI) for the association between metabolic phenotype and colorectal/colon cancer among WHI normal-weight women without NSAIDs use.

Background: The prevalence of metabolically unhealthy phenotype in normal-weight adults is 30%, and few studies have explored the association between metabolic phenotype and colorectal cancer incidence in normal-weight individuals. Our aim was to compare the risk of colorectal cancer in normal-weight postmenopausal women who were characterized by either the metabolically healthy phenotype or the metabolically unhealthy phenotype.Methods: A large prospective cohort, the Women's Health Initiative, was used. The analytic sample included 5,068 postmenopausal women with BMI 18.5 to 2. Metabolic phenotype was defined using the Adult Treatment Panel-III definition, excluding waist circumference; therefore, women with one or none of the four components (elevated triglycerides, low high-density lipoprotein cholesterol, elevated blood pressure, and elevated fasting glucose) were classified as metabolically healthy. Multivariable Cox proportional hazards regression was used to estimate adjusted HRs for the association between metabolic phenotype and risk of colorectal cancer.Results: Among normal-weight women, those who were metabolically unhealthy had higher risks of colorectal cancer (HR, 1.49; 95% CI, 1.02–2.18) compared with those who were metabolically healthy.Conclusions: A metabolically unhealthy phenotype was associated with higher risk of colorectal cancer among normal-weight women.Impact: Normal-weight women should still be evaluated for metabolic health and appropriate steps taken to reduce their risk of colorectal cancer. Cancer Epidemiol Biomarkers Prev; 26(2); 155–61. ©2017 AACR.

Chronic low back pain (cLBP) is a common and highly disabling problem world-wide. Although many treatment options exist, it is unclear how to best sequence the multitude of care options to provide the greatest benefit to patients.The Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER) trial uses a pragmatic, randomized, stepped design. Enrollment targets 2529 participants from 20 Veterans Affairs (VA) medical centers. Participants with chronic low back pain will first be randomized to one of three options: 1) an internet-based self-management program (Pain EASE); 2) a tailored physical therapy program (Enhanced PT); or 3) continued care with active monitoring (CCAM), a form of usual care. Participants not achieving a 30% or 2-point reduction on the study's primary outcome (Brief Pain Inventory Pain Interference (BPI-PI) subscale), 3 months after beginning treatment may undergo re-randomization in a second step to cognitive behavioral therapy for chronic pain, spinal manipulation therapy, or yoga. Secondary outcomes include pain intensity, back pain-related disability, depression, and others. Participants will be assessed every three months until 12 months after initiating their final trial therapy. Companion economic and implementation analyses are also planned.The SCEPTER trial is currently recruiting and enrolling participants.Trial results will inform treatment decisions for the stepped management of chronic low back pain - a common and disabling condition. Additional analyses will help tailor treatment selection to individual patient characteristics, promote efficient resource use, and identify implementation barriers of interventions.clinicaltrials.gov Identifier: NCT04142177.

OBJECTIVE: To explore whether using a single matched or composite outcome might impact the results of previous randomised controlled trials (RCTs) testing exercise for non-specific low back pain (NSLBP). The first objective was to explore whether a single matched outcome generated a greater standardised mean differences (SMD) when compared to the original unmatched primary outcome SMD. The second objective was to explore whether a composite measure, comprised of matched outcomes, generated a greater SMD when compared to the original primary outcome SMD. DESIGN: We conducted exploratory secondary analyses of data. SETTING: Seven RCTs were included, of which two were based in the USA (University research clinic, Veterans Affairs medical centre) and the UK (primary care clinics, nonmedical centres). One each were based in Norway (clinics), Brazil (primary care), and Japan (outpatient clinics). PARTICIPANTS: The first analysis comprised 1) five RCTs (n=1,033) that used an unmatched primary outcome but included (some) matched outcomes as secondary outcomes, and the second analysis comprised 2) four RCTs (n=864) that included multiple matched outcomes by developing composite outcomes. INTERVENTION: Exercise compared to no exercise. MAIN OUTCOME MEASURES: The composite consisted of standardised averaged matched outcomes. All analyses replicated the RCTs' primary outcome analyses. RESULTS: Of five RCTs, three had greater SMDs with matched outcomes (pooled effect SMD 0.30 (95% CI 0.04, 0.56), p=0.02) compared to an unmatched primary outcome (pooled effect SMD 0.19 (95% CI -0.03, 0.40) p=0.09). Of four composite outcome analyses, three RCTs had greater SMDs in the composite outcome (pooled effect SMD 0.28 (95%CI 0.05, 0.51) p=0.02) compared to the primary outcome (pooled effect SMD 0.24 (95%CI -0.04, 0.53) p=0.10). CONCLUSIONS: These exploratory analyses suggest that using an outcome matched to exercise treatment targets in NSLBP RCTs may produce greater SMDs than an unmatched primary outcome. Composite outcomes could offer a meaningful way of investigating superiority of exercise than single domain outcomes.

Background Chronic 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. Methods Military 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. Results Recruitment 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. Conclusions Results 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.

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.

Endometriosis is a chronic, painful disease without a cure. Due largely to chronic pain, endometriosis can lead to significant physical, mental, relationship, and financial burdens. Within the conventional single provider model of care-in which the patient is primarily taken care of by her physician and complementary strategies based on psychology, nutrition, pain medicine, pelvic physical therapy, and so on may not be readily available in a coordinated manner-most women with endometriosis live with unresolved pain and the consequences of that pain. We therefore propose that there is an urgent need to search for alternative models of care. In the current paper, we discuss our experiences with an model of care in which we adopt a long-term, patient-focused, and multidisciplinary chronic care model for women with endometriosis. Our objective is to improve long-term clinical outcomes for women with endometriosis. For geographical areas and healthcare systems in which it is feasible, we propose consideration of this multidisciplinary model of care as an alternative to the single provider model and offer guidance for those considering establishment of such a program. We also initiate a conversation about which clinical outcomes pertaining to endometriosis are important and should be tracked to assess the efficacy and value of multidisciplinary and other endometriosis healthcare models.

ObjectiveTo evaluate the cost-effectiveness of neuromuscular ultrasound (NMUS) for the evaluation of focal neuropathies.MethodsA prior prospective, randomized, double-blind controlled trial demonstrated that NMUS, when added to electrodiagnostic testing, resulted in improved clinical outcomes after 6 months of follow-up. From this study, we abstracted quality-adjusted life-years (QALYs) from the 36-item Short Form Health Survey and entered this health-utility estimate into a mixed trial and model-based cost-effectiveness analysis from the societal perspective. Costs of intervention (NMUS) were estimated from Medicare payment rates for Current Procedural Terminology codes. Health care use was otherwise estimated to be equal, but sensitivity analyses further examined this and other key assumptions. Incremental cost-effectiveness ratio (ICER) was used as the primary outcome with a willingness-to-pay threshold of $50,000 per QALY.ResultsThe predicted mean health outcome associated with use of NMUS was 0.079 QALY, and the mean cost was $37, resulting in an ICER of $463 per QALY. Results and conclusions remained robust across all sensitivity analyses, including variations in time horizon, initial distribution of health states, costs, and effectiveness.ConclusionsFrom a societal perspective, the addition of NMUS to electrodiagnostic testing when evaluating a focal neuropathy is cost-effective. A study of longer follow-up incorporating total health care use would further quantify the value of NMUS.ClinicalTrials.gov identifier:NCT01394822.

OBJECTIVE: The primary aim of this study was to examine differences in yoga practice between persons with and without chronic pain. Secondarily, we describe use of the Essential Properties of Yoga Questionnaire, Short Form (EPYQ-SF) for self-report. DESIGN: Participants were members of an existing cohort of veterans who completed a 2015-2016 survey focused on pain and nonpharmacological health practices. Cohort members who reported yoga in the past year (n=174 [9.4%] of 1850) were eligible for the present study, which used multiple-contact mixed-mode survey methodology to collect data on yoga practices. The EPYQ-SF was used to assess properties and context of yoga practice. Practice patterns were compared for participants with and without chronic pain. To explore potential reasons for reported yoga practice patterns, focused semi-structured interviews were conducted with a subset of participants. RESULTS: Of 174 participants contacted, 141 (82%) returned the yoga questionnaire and 110 (78% of respondents) were still practicing yoga. Among yoga practitioners, 41 (37%) had chronic pain. Practitioners with chronic pain reported gentler (2.8 vs 3.1, 5-point scale) and less active (2.9 versus 3.3) yoga practice than those without. Those with chronic pain attended yoga studios less frequently and reported shorter yoga practices than those without. Most yoga practice was self-directed and at home. CONCLUSIONS: Differences in yoga practice of persons with and without chronic pain have implications for implementation of yoga interventions for chronic pain. Future interventions should focus on alternative individual delivery formats or addressing barriers to group practice among people with chronic pain.

Background Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP). Objective Using data from a recent trial of yoga for military veterans with cLBP, we analyzed the incremental cost-effectiveness of yoga compared with usual care. Methods Participants (n=150) were randomized to either 2× weekly, 60-minute yoga sessions for 12 weeks, or to delayed treatment (DT). Outcomes were measured at 12 weeks, and 6 months. Quality-adjusted life years (QALYs) were measured using the EQ-5D scale. A 30% improvement on the Roland-Morris Disability Questionnaire (primary outcome) served as an additional effectiveness measure. Intervention costs including personnel, materials, and transportation were tracked during the study. Health care costs were obtained from patient medical records. Health care organization and societal perspectives were examined with a 12-month horizon. Results Incremental QALYs gained by the yoga group over 12 months were 0.043. Intervention costs to deliver yoga were $307/participant. Negligible differences in health care costs were found between groups. From the health care organization perspective, the incremental cost-effectiveness ratio to provide yoga was $4488/QALY. From the societal perspective, yoga was "dominant" providing both health benefit and cost savings. Probabilistic sensitivity analysis indicates an 89% chance of yoga being cost-effective at a willingness-to-pay of $50,000. A scenario comparing the costs of yoga and physical therapy suggest that yoga may produce similar results at a much lower cost. Discussion/conclusions Yoga is a cost-effective treatment for reducing pain and disability among military veterans with cLBP.

Objectives Yoga demonstrates beneficial effects in many populations, yet our understanding of how yoga brings about these effects is quite limited. Among the proposed mechanisms of yoga are increasing psychological resources (mindfulness, body consciousness, self-transcendence, spiritual peace, and social connectedness) that may bring about salutary effects on emotional wellbeing. Further, yoga is a complex practice comprising meditation, active and restorative postures, and breathwork; however little is known about how different components may affect mechanisms. We aimed to determine how an acute session of yoga (and its specific components) related to pre- to post- session changes in proposed mechanisms (psychological resources) and whether those changes were associated with positive changes in emotions. Design 144 regular yoga practitioners completed measures of mindfulness, body consciousness, self-transcendence, social connectedness, spiritual peace, and exercise-induced emotions (positive engagement, revitalization, tranquility, exhaustion) immediately before and after a yoga session (N = 11 sessions, each a different type of yoga). Perceived properties of each yoga session, exercise exertion and engagement with the yoga teacher were assessed immediately following the session. Results Pre-to post- yoga, levels of positive emotions (engagement, tranquility and revitalization) increased while exhaustion decreased. Further, all psychological resources increased and closely tracked improved emotions. Additionally, aspects of the yoga session correlated with changes in psychological resources (mechanisms) and emotions. Conclusions Yoga may influence multiple psychological mechanisms that influence emotional well-being. Further, different types of yoga may affect different mechanisms. Results can inform yoga interventions aiming to optimize effects through specific mechanisms such as mindfulness or spirituality.

Background Coffee and tea are two of the most widely consumed beverages worldwide and have been associated with reduced risk of mortality in some studies. However, it is unknown whether consumption of these beverages is associated with survival to an advanced age. Objective To examine associations of coffee and tea consumption with survival to age 90 years. Design Prospective cohort study among participants from the Women's Health Initiative, recruited during 1993 to 1998 and followed up until March 31, 2018. Setting The setting included 40 US clinical centers. Participants A racially and ethnically diverse cohort of 27,480 older women, aged 65 to 81 years at baseline. Measurements Women were classified as having either survived to age 90 years or died before this age. Consumption of caffeinated and decaffeinated coffee and caffeinated tea was assessed at baseline and categorized as 0, 1, 2 to 3, or 4 or more cups/day. Associations of coffee and tea consumption with survival to age 90 years were examined using logistic regression models adjusted for sociodemographic characteristics, lifestyle behaviors, dietary quality, and chronic disease history. Results A total of 14,659 (53.3%) women survived to age 90 years during follow-up. Caffeinated coffee, decaffeinated coffee, or caffeinated tea consumption was not significantly associated with survival to age 90 years after adjusting for confounders. Findings did not significantly vary by smoking, body mass index, or race/ethnicity. Conclusion No amount of coffee or tea consumption was associated with late-age survival among older women. These findings may be reassuring to older women who consume coffee and tea as part of their daily diets but do not support drinking these beverages to achieve longevity.

Background The Lifestyle Interventions and Independence for Elders (LIFE) Study physical activity (PA) intervention was found to be cost-effective compared to health education (HE). However, long-term effects postintervention are unknown. Method This was a secondary analysis of LIFE Study data linked to Medicare claims data (2014–2016). Participants were linked via Social Security Numbers to Medicare claims data. Utilization and cost variables were analyzed using generalized linear models with negative binomial and Tweedie distributions. Unadjusted means and 95% confidence intervals were compared by year and overall stratified. Each model compared PA versus HE and adjusted for other baseline characteristics and stratified by study site. Additional models were stratified by baseline physical functioning assessment scores. Results Of the 1,635 LIFE Study participants, 804 (53.5%) were linked to Medicare claims with an average of 33 months of follow-up time during the 3-year data linkage period. Mean outpatient (6.6 vs 6.8), inpatient (0.40 vs 0.40), and other utilization metrics were similar between PA and HE groups. Costs were also similar for each group and each type of service, for example, outpatient: $2,070 versus $2,093 and inpatient: $4,704 versus $4,792. Regression results indicated no statistically significant differences between PA and HE groups. Conclusions While the LIFE Study demonstrated that PA reduced mobility disability in older adults and was cost-effective, it did not appear to affect long-term health care utilization costs posttrial. These findings suggest that it remains challenging to affect long-term health care costs using PA interventions effects.

Objective Millions 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. Methods Participants 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. Results Five 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. Conclusions The 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.

Recent clinical trials indicate that pharmacogenetic-guided treatment of major depressive disorder (MDD) results in higher treatment response rates by genetically matching patients to medications and avoiding a trial-and-error process.To evaluate the cost-effectiveness of a pharmacogenetic test (IDGx) that has demonstrated effectiveness compared with standard of care (SOC) medication management among patients with varied MDD severity.Data from a large prospective, randomized controlled trial of treatment-naive patients or patients with inadequately controlled MDD in general practice and psychiatric treatment settings were used to build a Markov state-transition probability model. Analyses were conducted from the societal perspective. Treatment response rates, mortality rates, direct and indirect medical costs, and utility inputs were derived from the reference study and published scientific literature. The cost of the pharmacogenetic test was $2,000. A 3% discount rate was used to discount costs and effects. Univariate one-way sensitivity analyses were performed to determine the effect of input parameters on net monetary benefit.For moderate to severe MDD, the model estimated a cumulative effect over 3 years of 2.07 quality-adjusted life-years (QALYs) for the pharmacogenetic-guided treatment group and 1.97 QALYs for the SOC group, including a lower probability of death from suicide (0.328% and 0.351%, respectively). Total costs over 3 years were $44,697 (IDGx) and $47,295 (SOC). This difference includes a savings of $2,918 in direct medical costs and $1,680 in indirect costs. Results were more pronounced when only severely depressed patients were evaluated.Pharmacogenetic testing among moderate to severe MDD patients improved QALYs and resulted in cost savings. Sensitivity analyses supported the robust nature of the current findings of the dominant IDGx test to guide treatment.Funding for this analysis was provided by AltheaDx, which is the manufacturer of the IDgenetix test. AltheaDx personnel assisted in the study design, data collection, and review of the manuscript. Maciel and Garces are employed by AltheaDx. Groessl has received funding as a consultant from American Specialty Health.

Yoga interventions are heterogeneous and vary along multiple dimensions. These dimensions may affect mental and physical health outcomes in different ways or through different mechanisms. However, most studies of the effects of yoga on health do not adequately describe or quantify the components of the interventions being implemented. This lack of detail prevents researchers from making comparisons across studies and limits our understanding of the relative effects of different aspects of yoga interventions. To address this problem, we developed the Essential Properties of Yoga Questionnaire (EPYQ), which allows researchers to objectively characterize their interventions. We present here the reliability and validity data from the final phases of this measure-development project. Analyses identified fourteen key dimensions of yoga interventions measured by the EPYQ: acceptance/compassion, bandhas, body awareness, breathwork, instructor mention of health benefits, individual attention, meditation and mindfulness, mental and emotional awareness, physicality, active postures, restorative postures, social aspects, spirituality, and yoga philosophy. The EPYQ demonstrated good reliability, as assessed by internal consistency and test-retest reliability analysis, and evidence suggests that the EPYQ is a valid measure of multiple dimensions of yoga. The measure is ready for use by clinicians and researchers. Results indicate that, currently, trained objective raters should score interventions to avoid reference frame errors and potential rating bias, but alternative approaches may be developed. The EPYQ will allow researchers to link specific yoga dimensions to identifiable health outcomes and optimize the design of yoga interventions for specific conditions.

Objectives To examine prospective associations between changes in physical activity (PA) and changes in physical performance measures (PPMs) over 6 years in older women. Design Prospective cohort study. Setting Forty clinical centers in the United States. Participants Women 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). Measurements Mixed-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 (

Objective The purpose of this study was to examine the relationship between dynapenia and metabolic risk factors in obese and nonobese older adults. Methods A total of 1453 men and women (age ≥70 years) from the Lifestyle Interventions and Independence for Elders (LIFE) Study were categorized as (1) nondynapenic/nonobese (NDYN-NO), (2) dynapenic/nonobese (DYN-NO), (3) nondynapenic/obese (NDYN-O), or (4) dynapenic/obese (DYN-O), based on muscle strength (Foundation for the National Institute of Health criteria) and body mass index. Dependent variables were blood lipids, fasting glucose, blood pressure, presence of at least 3 metabolic syndrome (MetS) criteria, and other chronic conditions. Results A significantly higher likelihood of having abdominal obesity criteria in NDYN-NO compared with DYN-NO groups (55.6 vs 45.1%, P ≤ .01) was observed. Waist circumference also was significantly higher in obese groups (DYN-O = 114.0 ± 12.9 and NDYN-O = 111.2 ± 13.1) than in nonobese (NDYN-NO = 93.1 ± 10.7 and DYN-NO = 92.2 ± 11.2, P ≤ .01); and higher in NDYN-O compared with DYN-O ( P = .008). Additionally, NDYN-O demonstrated higher diastolic blood pressure compared with DYN-O (70.9 ± 10.1 vs 67.7 ± 9.7, P ≤ .001). No significant differences were found across dynapenia and obesity status for all other metabolic components ( P > .05). The odds of having MetS or its individual components were similar in obese and nonobese, combined or not with dynapenia (nonsignificant odds ratio [95% confidence interval]). Conclusion Nonobese dynapenic older adults had fewer metabolic disease risk factors than nonobese and nondynapenic older adults. Moreover, among obese older adults, dynapenia was associated with lower risk of meeting MetS criteria for waist circumference and diastolic blood pressure. Additionally, the presence of dynapenia did not increase cardiometabolic disease risk in either obese or nonobese older adults.

Background Walking independently is basic to human functioning. The Lifestyle Interventions and Independence for Elders (LIFE) studies were developed to assess whether initiating physical activity could prevent major mobility disability (MMD) in sedentary older adults. Methods We review the development and selected findings of the LIFE studies from 2000 through 2019, including the planning phase, the LIFE-Pilot Study, and the LIFE Study. Results The planning phase and the LIFE-Pilot provided key information for the successful implementation of the LIFE Study. The LIFE Study, involving 1635 participants randomized at eight sites throughout the United States, showed that compared with health education, the physical activity program reduced the risk of the primary outcome of MMD (inability to walk 400 m: hazard ratio = 0.82; 95% confidence interval = 0.69-0.98; P = .03), and that the intervention was cost-effective. There were no significant effects on cognitive outcomes, cardiovascular events, or serious fall injuries. In addition, the LIFE studies provided relevant findings on a broad range of other outcomes, including health, frailty, behavioral outcomes, biomarkers, and imaging. To date, the LIFE studies have generated a legacy of 109 peer-reviewed publications, 19 ancillary studies, and 38 independently funded grants and clinical trials, and advanced the development of 59 early career scientists. Data and biological samples of the LIFE Study are now publicly available from a repository sponsored by the National Institute on Aging (https://agingresearchbiobank.nia.nih.gov). Conclusions The LIFE studies generated a wealth of important scientific findings and accelerated research in geriatrics and gerontology, benefiting the research community, trainees, clinicians, policy makers, and the general public. J Am Geriatr Soc 68:872-881, 2020.

Endometriosis is a chronic, painful disease without a cure. Due largely to chronic pain, endometriosis can lead to significant physical, mental, relationship, and financial burdens. Within the conventional single provider model of care—in which the patient is primarily taken care of by her physician and complementary strategies based on psychology, nutrition, pain medicine, pelvic physical therapy, and so on may not be readily available in a coordinated manner—most women with endometriosis live with unresolved pain and the consequences of that pain. We therefore propose that there is an urgent need to search for alternative models of care. In the current paper, we discuss our experiences with an model of care in which we adopt a long-term, patient-focused, and multidisciplinary chronic care model for women with endometriosis. Our objective is to improve long-term clinical outcomes for women with endometriosis. For geographical areas and healthcare systems in which it is feasible, we propose consideration of this multidisciplinary model of care as an alternative to the single provider model and offer guidance for those considering establishment of such a program. We also initiate a conversation about which clinical outcomes pertaining to endometriosis are important and should be tracked to assess the efficacy and value of multidisciplinary and other endometriosis healthcare models.

Background: There are gaps in delivering evidence-based care for patients with chronic liver disease and cirrhosis. Objective: Our objective was to use interactive user-centered design methods to develop the Cirrhosis Order Set and Clinical Decision Support (CirrODS) tool in order to improve clinical decision-making and workflow. Methods: Two work groups were convened with clinicians, user experience designers, human factors and health services researchers, and information technologists to create user interface designs. CirrODS prototypes underwent several rounds of formative design. Physicians (n=20) at three hospitals were provided with clinical scenarios of patients with cirrhosis, and the admission orders made with and without the CirrODS tool were compared. The physicians rated their experience using CirrODS and provided comments, which we coded into categories and themes. We assessed the safety, usability, and quality of CirrODS using qualitative and quantitative methods. Results: We created an interactive CirrODS prototype that displays an alert when existing electronic data indicate a patient is at risk for cirrhosis. The tool consists of two primary frames, presenting relevant patient data and allowing recommended evidence-based tests and treatments to be ordered and categorized. Physicians viewed the tool positively and suggested that it would be most useful at the time of admission. When using the tool, the clinicians placed fewer orders than they placed when not using the tool, but more of the orders placed were considered to be high priority when the tool was used than when it was not used. The physicians’ ratings of CirrODS indicated above average usability. Conclusions: We developed a novel Web-based combined clinical decision-making and workflow support tool to alert and assist clinicians caring for patients with cirrhosis. Further studies are underway to assess the impact on quality of care for patients with cirrhosis in actual practice.

BACKGROUND There are gaps in delivering evidence-based care for patients with chronic liver disease and cirrhosis. OBJECTIVE Our objective was to use interactive user-centered design methods to develop the Cirrhosis Order Set and Clinical Decision Support (CirrODS) tool in order to improve clinical decision-making and workflow. METHODS Two work groups were convened with clinicians, user experience designers, human factors and health services researchers, and information technologists to create user interface designs. CirrODS prototypes underwent several rounds of formative design. Physicians (n=20) at three hospitals were provided with clinical scenarios of patients with cirrhosis, and the admission orders made with and without the CirrODS tool were compared. The physicians rated their experience using CirrODS and provided comments, which we coded into categories and themes. We assessed the safety, usability, and quality of CirrODS using qualitative and quantitative methods. RESULTS We created an interactive CirrODS prototype that displays an alert when existing electronic data indicate a patient is at risk for cirrhosis. The tool consists of two primary frames, presenting relevant patient data and allowing recommended evidence-based tests and treatments to be ordered and categorized. Physicians viewed the tool positively and suggested that it would be most useful at the time of admission. When using the tool, the clinicians placed fewer orders than they placed when not using the tool, but more of the orders placed were considered to be high priority when the tool was used than when it was not used. The physicians’ ratings of CirrODS indicated above average usability. CONCLUSIONS We developed a novel Web-based combined clinical decision-making and workflow support tool to alert and assist clinicians caring for patients with cirrhosis. Further studies are underway to assess the impact on quality of care for patients with cirrhosis in actual practice.

Background The 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. Methods Sedentary 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. Results Recruitment 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. Conclusions Results 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 Registration ClinicalTrials # NCT03544879; Retrospectively registered 4 June, 2018.

BACKGROUND The spectrum of gastroenterology-related diseases related to obesity is growing. Few clinical tools exist to aid in clinician-guided dietary counseling. GOALS (1) Develop and validate a 1-page diet history form that would provide information on dietary factors that can contribute to gastrointestinal (GI) illness and to assess adherence to the Mediterranean diet; and (2) evaluate the form in a general GI clinic to determine its potential utility as a clinical tool. STUDY A 1-page diet history form was developed and underwent qualitative and quantitative validation in comparison to a formal diet evaluation by a registered dietitian. The form was then evaluated in consecutive patients attending a general GI clinic, and analyzed for overall diet content, compliance with a Mediterranean diet, and presence of high-risk (red flag) dietary behaviors. RESULTS The form was evaluated in 134 patients. In a validation cohort (n=30) the qualitative dietary components measured were highly concordant with a formal dietary interview. Total daily calorie intake correlated with formal dietary review (R=0.61), but tended to underestimate total calories due to less precision in portion size. The prospective cohort (n=104) patients had a mean body mass index of 29.8. Overall, 52.9% were obese, 50% had metabolic syndrome, and 51% had a primary GI illness directly impacted by dietary factors (gastroesophageal reflux, irritable bowel, fatty liver). Overall, 85.6% of patients documented red flag behaviors. Patients with obesity trended for more red flags than overweight or normal body mass index groups. CONCLUSION A 1-page diet questionnaire correlated well with formal dietary assessment and identified clinically relevant dietary interventions in a high percentage of GI patients.

Background: Currently 4 million persons in the US have active hepatitis C virus (HCV) infection and most have never successfully completed antiviral treatment. Newer therapies herald potential for wider uptake and acceptance of treatment, but the number of hepatology specialists is limited and newer models are needed to increase access to care. The aim of this study is to describe a collaborative primary care-based clinic for HCV treatment. Methods: Retrospective analysis of a collaborative primary care clinic developed for the evaluation and treatment of patients with chronic hepatitis C at one VA medical center. A half-day clinic was organized with 4 primary care MDs, 2 hepatologists, 2 nurse practitioners, and a co-located psychiatrist, pharmacist and nurse case manager. Clinic productivity and outcomes related to the number of patients who initiated and completed treatment with direct acting antivirals (DAA) and pegylated interferon and ribavirin were evaluated. Results: In this 18 month period, the clinic had 1890 confirmed HCV registry patients and 1690 clinic visits. 74 HCV genotype 1 patients initiated DAA therapy. Primary care providers treated 47 patients (32% cirrhotic) and hepatologists treated 27 patients (48% cirrhotic). Final SVR rate was 54.6% (39.2% cirrhotics vs. 65.2% noncirrhotics). SVR rates were higher in patients with primary care providers (61.7%) vs. hepatologists (44.4%). Despite numerous adverse events, early treatment termination for adverse events occurred in 5.3% vs. 21.3% for virologic non-response. Multivariate analysis revealed no significant differences between primary care and hepatology for SVR and treatment discontinuations. Conclusion: This clinic demonstrated effectiveness and safety with DAA therapy. This illustrates potential for a primary care based collaborative clinic, which will be crucial for expanding access to effective HCV care.

Algorithms for the diagnosis, management, and follow-up have been proposed for patients hospitalized for inflammatory bowel disease (IBD) colitis flare. The degree to which providers adhere to these algorithms is unknown. This study evaluated the quality of care in IBD patients hospitalized for disease-associated exacerbations and factors correlated with higher degrees of care. Retrospective chart review of 34 patients during 60 admissions to the medicine service for IBD colitis exacerbation between 2005 and 2012 at the Veterans Affairs San Diego Medical Center. Examined factors included laboratory testing, timing of consultation and intravenous steroids, abdominal imaging, endoscopic examination, venous thromboembolism (VTE) prophylaxis, narcotic use, Clostridium difficile and cytomegalovirus testing, symptomatology at discharge, timing of follow-up, and rates of readmission and mortality. Quality of care varied among the factors studied, ranging from 30.5 % for pharmacologic VTE prophylaxis to 84.7 % for gastroenterology consultation within 24 h. Of 60 admissions, 22 % were not tested for C. difficile. Fifteen percent of patients were discharged before meeting commonly used discharge criteria. Eighty percent were seen in clinic at any time post-discharge; 6.7 % were readmitted; 10 % were lost to follow-up; 1.7 % opted for outside follow-up; and 1.7 % expired. The quality of care for patients admitted with IBD colitis flares is variable. These data outline opportunities for improvement, particularly in regard to pain management, VTE prophylaxis, and follow-up. Further studies are needed to test intervention strategies for practice improvement.

There is evidence to suggest that yoga may reduce PTSD symptoms. It is unclear at this point, however, whether or not yoga reduces PTSD symptoms any more than a non-specific intervention given inconsistent findings and methodological limitations. Nonetheless, additional research in this area is important because of the high level of interest in and acceptability of yoga. Ultimately, yoga may be most effective when taught using trauma-sensitive guidelines and within a framework that helps the practitioner to apply the experience to coping with symptoms.

Background Growth-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. Methods 1128 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. Results Our 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. Conclusions Multiple 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 registration ClinicalTrials.gov Identifier: NCT02170441. Electronic supplementary material The online version of this article (10.1186/s12879-018-3013-0) contains supplementary material, which is available to authorized users.

BACKGROUND: Hospitalization reduces mobility for many older adults, which in turn is associated with an increased risk of hospitalization. Physical function screening may identify an at-risk population for intervention. The Mobility Assessment Tool – short form (MAT-sf) is a brief, animated, computer-based means of assessing mobility that predicts mobility disability. This study explored whether baseline MAT-sf scores are associated with number of hospitalizations and time to first hospitalization across a median follow-up of 2.7 years. DESIGN: Post-hoc analysis of prospectively-gathered data from the Lifestyle Interventions and Independence for Elders (LIFE) Study, a randomized clinical trial of lifestyle interventions to preserve mobility in older adults, conducted in eight U.S. academic medical centers. PARTICIPANTS: Among 1635 sedentary community-dwelling older adults enrolled in LIFE, 1574 completed baseline physical function screening including the MAT-sf, with baseline scores ranging from 30.2 (low function) to 69.8 (high function) on a scale from 30-80. MEASUREMENTS: Number of hospitalizations and time to first hospitalization, adjusted for age, gender, race, living alone, clinical site, baseline comorbidities, # prescription medications, and cognition. RESULTS: Of the 1557 participants with data regarding hospitalization status, 726 (47%) experienced at least one hospitalization; the majority (78%) of these experienced 1-2 hospitalizations. For every 10-point difference in MAT-sf score, the rate of all hospitalizations was higher by 19% in those with lower scores (adjusted rate ratio 1.20, 95% CI: 1.08-1.32, p

Author(s): Garfein, RS; Catanzaro, DG; Rodwell, TC; Avalos, E; Jackson, RL; Kaping, J; Evasco, H; Rodrigues, C; Crudu, V; Lin, S-YG; Groessl, E; Hillery, N; Trollip, A; Ganiats, T; Victor, TC; Eisenach, K; Valafar, F; Channick, J; Qian, L; Catanzaro, A | Abstract: ObjectiveTo develop and evaluate rapid, molecular-based drug susceptibility testing (DST) for extensively drug-resistant tuberculosis (XDR-TB), we assembled a phenotypically and genotypically diverse collection of Mycobacterium tuberculosis isolates from patients evaluated for drug resistance in four high-burden countries.MethodsM. tuberculosis isolates from India (n = 111), Moldova (n = 90), the Philippines (n = 96), and South Africa (n = 103) were selected from existing regional and national repositories to maximize phenotypic diversity for resistance to isoniazid, rifampin (RMP), moxifloxacin, ofloxacin, amikacin, kanamycin, and capreomycin. MGIT™ 960 was performed on viable isolates in one laboratory using standardized procedures and drug concentrations. Genetic diversity within drug resistance phenotypes was assessed.ResultsNineteen distinct phenotypes were observed among 400 isolates with complete DST results. Diversity was greatest in the Philippines (14 phenotypes), and least in South Africa (9 phenotypes). Nearly all phenotypes included multiple genotypes. All sites provided isolates resistant to injectables but susceptible to fluoroquinolones. Many patients were taking drugs to which their disease was resistant.DiscussionDiverse phenotypes for XDR-TB-defining drugs, including resistance to fluoroquinolones and/or injectable drugs in RMP-susceptible isolates, indicate that RMP susceptibility does not ensure effectiveness of a standard four-drug regimen. Rapid, low-cost DST assays for first- and second-line drugs are thus needed.

Yoga-based practices (YBP) typically involve a combination of movement sequences, conscious regulation of the breath, and techniques to engage attention. However, little is known about whether effects of YBP result from the synergistic combination of these components, or whether a subset may yield similar effects. In this study we compared the effect of a movement-focused practice and a breath-focused practice on stress parameters (perceived stress and salivary cortisol) and sustained attention (response inhibition) in yoga naive university students. While participants of both programs showed a reduction in perceived stress and salivary cortisol, only the breath-focused group showed improvements in sustained attention. In addition, improvement in sustained attention was correlated with reduction in perceived stress but not with reduction in salivary cortisol. We discuss these findings in the context of a theoretical framework outlining bottom-up neurophysiological and top-down neurocognitive mechanisms hypothesized to be engaged by YBP.

Background & Objectives In healthcare, the routine use of evidence-based specialty care management plans is mixed. Targeted computerized clinical decision support (CCDS) interventions can improve physician adherence, but adoption depends on CCDS’ ‘fit’ within clinical work. We analyzed clinical work in outpatient and inpatient settings as a basis for developing guidelines for optimizing CCDS design. Methods The contextual design approach guided data collection, collation and analysis. Forty (40) consenting physicians were observed and interviewed in general internal medicine inpatient units and gastroenterology (GI) outpatient clinics at two academic medical centers. Data were collated using interpretive debriefing, and consolidated using thematic analysis and three work modeling approaches (communication flow, sequence and artifact models). Results Twenty-six consenting physicians were observed at Site A and 14 at Site B. Observations included attending (33%) and resident physicians. During research team debriefings, 220 of 341 unique topics were categorized into 5 CCDS-relevant themes. Resident physicians relied on patient assessment & planning processes to support their roles as communication and coordination hubs within the medical team. Artifact analysis further elucidated the evolution of assessment and planning over work shifts. Conclusions The usefulness of CCDS tools may be enhanced in clinical care if the design: 1) accounts for clinical work that is distributed across people, space, and time; 2) targets communication and coordination hubs (specific roles) that can amplify the usefulness of CCDS interventions; 3) integrates CCDS with early clinical assessment & planning processes; and 4) provides CCDS in both electronic & hardcopy formats. These requirements provide a research agenda for future research in clinician-CCDS integration.

BACKGROUND: Findings from epidemiological studies have found physical activity (PA) is associated with lower colorectal cancer (CRC) risk. Recent studies have found an increased CRC risk with higher sitting time (ST); however, many studies did not include PA as a potential confounder. The objective of this project was to investigate the independent and joint associations of ST and PA with risk of incident colorectal cancer, specifically colon and rectal cancer. METHODS: Participants in the Women’s Health Initiative Observational Study (n = 74,870), 50–79 years of age self-reported ST and PA at baseline, year 3 and year 6. Incident CRC was the primary outcome; colon and rectal cancers were secondary outcomes which were centrally adjudicated. RESULTS: Over a 13-year follow-up, 1,145 incident cases of CRC were documented. A positive age-adjusted association was found between higher ST (≥10 versus 20 MET-hrs/week) group was 0.81 (95% CI: 0.66 – 1.00; p for trend 0.04). Compared to inactive women with high ST (≥ 10 hrs/d), there was a trend for reduced multivariable CRC risks with higher PA regardless of ST level (interaction=0.64) CONCLUSIONS: We observed an inverse association between leisure time PA and risk of CRC, particularly for rectal cancer. There was no association between ST and CRC in multivariable models.

Summary Objectives Comparison groups are essential for accurate testing and interpretation of yoga intervention trials. However, selecting proper comparison groups is difficult because yoga comprises a very heterogeneous set of practices and its mechanisms of effect have not been conclusively established. Methods We conducted a systematic review of the control and comparison groups used in published randomized controlled trials (RCTs) of yoga. Results We located 128 RCTs that met our inclusion criteria; of these, 65 included only a passive control and 63 included at least one active comparison group. Primary comparison groups were physical exercise (43%), relaxation/meditation (20%), and education (16%). Studies rarely provided a strong rationale for choice of comparison. Considering year of publication, the use of active controls in yoga research appears to be slowly increasing over time. Conclusions Given that yoga has been established as a potentially powerful intervention, future research should use active control groups. Further, care is needed to select comparison conditions that help to isolate the specific mechanisms of yoga's effects.

Persons in recovery, providers, and policymakers alike are advocating for recovery-oriented mental health care, with the promotion of recovery becoming a prominent feature of mental health policy in the United States and internationally. One step toward creating a recovery-oriented system of care is to use recovery-oriented outcome measures. Numerous instruments have been developed to assess progress towards mental health recovery. This review identifies instruments of mental health recovery and evaluates the appropriateness of their use including their psychometric properties, ease of administration, and service-user involvement in their development. A literature search using the Medline and Psych-INFO databases was conducted, identifying 21 instruments for potential inclusion in this review, of which thirteen met inclusion criteria. Results suggest only three instruments (25%) have had their psychometric properties assessed in three or more unique samples of participants. Ease of administration varied between instruments, and for the majority of instruments, development included service user involvement. This review updates and expands previous reviews of instruments to assess mental health recovery. As mental health care continues to transform to a recovery-oriented model of service delivery, this review may facilitate selection of appropriate assessments of mental health recovery for systems to use in evaluating and improving the care they provide.

Background & Aims The Veterans Health Administration (VHA) is the largest single provider of care for hepatitis C virus (HCV) infection in the United States. We analyzed the cost effectiveness of treatment with the HCV protease inhibitors boceprevir and telaprevir in a defined managed care population of 102,851 patients with untreated chronic genotype 1 infection. Methods We used a decision-analytic Markov model to examine 4 strategies: standard dual-therapy with pegylated interferon-alfa and ribavirin (PR), the combination of boceprevir and PR triple therapy, the combination of telaprevir and PR, or no antiviral treatment. A sensitivity analysis was performed. Sources of data included published rates of disease progression, the census bureau, and VHA pharmacy and hospitalization cost databases. Results The estimated costs for treating each patient were $8000 for PR, $31,300 for boceprevir and PR, and $41,700 for telaprevir and PR. Assuming VHA treatment rates of 22% and optimal rates of sustained virologic response, PR, boceprevir and PR, and telaprevir and PR would reduce relative liver-related deaths by 5.2%, 10.9%, and 11.5%, respectively. Increasing treatment rates to 50% would reduce liver-related deaths by 12%, 24.7%, and 26.1%, respectively. The incremental cost-effectiveness ratios were $29,184/quality-adjusted life-years for boceprevir and PR and $44,247/quality-adjusted life-years for telaprevir and PR vs only PR. With the current 22% treatment rate, total system-wide costs to adopt boceprevir and PR or telaprevir and PR would range from $708 to $943 million. Conclusions Despite substantial up-front costs of treating HCV-infected patients in the VHA with PR, or telaprevir and PR, each regimen improves quality of life and extends life expectancy by reducing liver-related morbidity and mortality, and should be cost effective. Further efforts to expand access to direct-acting antiviral therapy are warranted.

OBJECTIVES: To describe several recruitment parametersderived from the Lifestyle Interventions and Independencefor Elders pilot (LIFE-P) study for use in a full-scale trial ofmobility disability prevention.DESIGN: A description of the recruiting methods andbaseline characteristics of a four-site randomized, con-trolled trial testing the effectiveness of a physical activityintervention at preventing mobility disability.SETTING: The Cooper Institute, Dallas, Texas; StanfordUniversity, Stanford, California; University of Pittsburgh,Pittsburgh,Pennsylvania;andWakeForestUniversity,Win-ston-Salem, North Carolina.PARTICIPANTS: Community-livingpersonsaged70to89whowereabletowalk400mwithin15minutesandwereathigh risk for disability (scoringo10 on the Short PhysicalPerformance Battery (SPPB)) but without comorbidity se-vere enough to preclude full study participation.MEASUREMENTS: Measures of efficiency includednum-ber of randomized participants per recruitment techniqueand costsper randomized participantacross randomizationtechniques.RESULTS: The 9-month recruiting period resulted in3,141 telephone screens, of which 424 (13.5%) partici-pants were randomized (68.9% women, 25.7% minorities,41.5% with SPPB scoreso8). Forty percent of telephone-screened participants were excluded primarily because ofregular participation in physical activity, health exclusions,or self-reported mobility disability. Of the 1,252 personsattempting the physical performance assessments, 41%scored above the SPPB cutoff. Of the 566 remaining eligi-ble, 9.9% could not complete the 400-m walk, and another18.9% had various medical exclusions. Direct mailing wasthe most productive recruitment strategy (61.6% of allrandomized participants). Recruitment cost approximately$439 per randomized participant.CONCLUSION: The LIFE study achieved all recruitmentgoals and demonstrated the feasibility of recruiting high-risk community-dwelling older persons for trials of disabi-lity prevention in diverse geographic areas. J Am GeriatrSoc 55:674–683, 2007.Key words: recruitment; clinical trials; prevention ofmobility disability; physical activity

Introduction Chronic 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. Design Participants 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/Participants One hundred and fifty military veterans with cLBP were recruited from a major Veterans Affairs Medical Center in California. Intervention Yoga 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 measures The primary outcome was Roland−Morris Disability Questionnaire scores after 12 weeks. Pain intensity was identified as an important secondary outcome. Results Participant 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. Conclusions Yoga 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 registration This study is registered at www.clinicaltrials.gov NCT02524158.

Background: The prevalence of metabolically unhealthy phenotype in normal-weight adults is 30%, and few studies have explored the association between metabolic phenotype and colorectal cancer incidence in normal-weight individuals. Our aim was to compare the risk of colorectal cancer in normal-weight postmenopausal women who were characterized by either the metabolically healthy phenotype or the metabolically unhealthy phenotype. Methods: A large prospective cohort, the Women's Health Initiative, was used. The analytic sample included 5,068 postmenopausal women with BMI 18.5 to Results: Among normal-weight women, those who were metabolically unhealthy had higher risks of colorectal cancer (HR, 1.49; 95% CI, 1.02–2.18) compared with those who were metabolically healthy. Conclusions: A metabolically unhealthy phenotype was associated with higher risk of colorectal cancer among normal-weight women. Impact: Normal-weight women should still be evaluated for metabolic health and appropriate steps taken to reduce their risk of colorectal cancer. Cancer Epidemiol Biomarkers Prev; 26(2); 155–61. ©2017 AACR.

Objectives Chronic 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. Methods A literature search through the beginning of 2015 was conducted in Pub Med for randomized control trials addressing treatment of CLBP with yoga. Results In 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. Discussion With 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. 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.

To evaluate the extent of variability in functional responses in participants in the Lifestyle Interventions and Independence for Elders (LIFE) study and to identify the relative contributions of intervention adherence, physical activity, and demographic and health characteristics to this variability.Secondary analysis.Multicenter institutions.A volunteer sample (N=1635) of sedentary men and women aged 70 to 89 years who were able to walk 400m but had physical limitations, defined as a Short Physical Performance Battery (SPPB) score of ≤9.Moderate-intensity physical activity (n=818) consisting of aerobic, resistance, and flexibility exercises performed both center-based (2times/wk) and home-based (3-4times/wk) sessions or health education program (n=817) consisting of weekly to monthly workshops covering relevant health information.Physical function (gait speed over 400m) and lower extremity function (SPPB score) assessed at baseline and 6, 12, and 24 months.Greater baseline physical function (gait speed, SPPB score) was negatively associated with change in gait speed (regression coefficient β=-.185; P.001) and change in SPPB score (β=-.365; P.001), whereas higher number of steps per day measured by accelerometry was positively associated with change in gait speed (β=.035; P.001) and change in SPPB score (β=.525; P.001). Other baseline factors associated with positive change in gait speed and/or SPPB score include younger age (P.001), lower body mass index (P.001), and higher self-reported physical activity (P=.002).Several demographic and physical activity-related factors were associated with the extent of change in functional outcomes in participants in the LIFE study. These factors should be considered when designing interventions for improving physical function in older adults with limited mobility.