Testing Biological and Psychological Pathways of Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.

BACKGROUND: Interventions that promote adaptive emotion regulation (ER) skills reduce pain in patients with chronic pain; however, whether the effects of yoga practice on chronic low back pain (CLBP) are due to improvements in ER remains to be examined. OBJECTIVE: This study will test whether the effects of yoga on CLBP (improved pain severity and interference) are mediated by improved ER, the extent to which effects are related to specific aspects of ER, and the role of pain sensitization as a mediator or moderator of effects. In this study, pain sensitization will be assessed by quantitative sensory testing and gene expression profiles to examine whether pain sensitization moderates yoga's effects on pain or whether yoga and ER abilities reduce pain sensitization, leading to decreased pain severity and interference. METHODS: For this 2-arm parallel group blinded randomized controlled trial, we will enroll 204 adults with CLBP who will be randomized to receive the yoga (n=102) or a control stretching and strengthening (n=102) intervention, which are delivered via web-based synchronous biweekly 75-minute sessions over 12 weeks. Participants are encouraged to practice postures or exercises for 25 minutes on other days using accessible prerecorded practice videos that are sent to participants digitally. Participants will be assessed at 5 time points: baseline, midintervention (6 weeks), postintervention (12 weeks), and 3- and 6-month follow-ups. Assessments of ER, pain severity and interference, pain sensitivity including somatosensory and gene expression profiles, and physical strength and flexibility will be conducted at each visit. The fidelity of the interventions is assessed using a manualized checklist to evaluate recorded group sessions to ensure consistent instructor delivery. RESULTS: The primary outcome will be the mean change in pain severity as measured by the Brief Pain Inventory-Short Form at 12 weeks. The primary mechanism of action is ER measured by change in the Difficulties in Emotion Regulation Scale total score. Secondary outcomes include pain sensitivity, physical strength and flexibility, pain interference, and quality of life. A mediation path analysis and series of moderated mediation path analyses will be conducted to test the study hypotheses. As of January 2024, we have enrolled 138 participants. We expect the study to be completed by May 2025. CONCLUSIONS: The study will provide important data for evaluating whether improvements in ER are responsible for reduced pain perception and pain sensitivity as well as increased quality of life in the context of chronic pain. The study findings have important implications for determining the mechanism of action for yoga and possibly other mind-body interventions as nonpharmacological therapies for pain management. The results of the study will inform the content, delivery, and measures for intervention trials involving yoga as a modality for relieving pain and improving function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04678297; https://clinicaltrials.gov/study/NCT04678297. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56016.

Is Blepharoplasty Cost-effective? Utility Analysis of Dermatochalasis and Cost-effectiveness Analysis of Upper Eyelid Blepharoplasty.

PURPOSE: This cross-sectional prospective study measured utility values of upper eyelid dermatochalasis to quantify its impact on quality of life and assess cost-effectiveness of upper blepharoplasty. METHODS: Utility of dermatochalasis was assessed using the standard reference gamble and time trade-off methods, with dual anchor points of perfect eye function and perfect health. The utility value obtained was used to create a Markov model and run a cost-effectiveness analysis of blepharoplasty as a treatment for dermatochalasis while utilizing the societal perspective. RESULTS: One hundred three patients with dermatochalasis recruited from an urban outpatient ophthalmology clinic completed the utility survey. The authors determined utility values for dermatochalasis ranging from 0.74 to 0.92 depending on the measurement method (standard reference gamble/time trade-off) and anchor points. The cost-effectiveness analysis yielded an incremental cost-effectiveness ratio of $3,146 per quality-adjusted life year, well under the conventional willingness-to-pay threshold of $50,000 per quality-adjusted life year. Probabilistic sensitivity analysis with Monte Carlo simulation demonstrated that blepharoplasty would be cost-effective in 88.1% of cases at this willingness-to-pay threshold. CONCLUSIONS: Dermatochalasis has an impact on quality of life that is significantly associated with level of perceived functional impairment. Rising health care costs have underscored the importance of providing value-based treatment to patients, and the results of this study suggest that blepharoplasty is a cost-effective treatment option for symptomatic bilateral upper eyelid dermatochalasis.

Impact of Glucose-Lowering Medications on Health-Related Quality of Life in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

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.

Yoga Plus Mantram Repetition to Reduce Chronic Pain in Veterans With Post-Traumatic Stress Disorder: A Feasibility Trial.

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.

Cost effectiveness of a technology-enhanced physical activity intervention for Latinas.

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.

Latinas report low levels of physical activity (PA) and high rates of related diseases. Existing evidence-based interventions for Latinas may need additional enhancements to help this population meet national PA guidelines. Enhancements could both increase the effectiveness and the costs of PA interventions. It is thus important to consider the costs and benefits of the different versions of these interventions, as these may influence whether the interventions are adopted and sustained on a larger scale in the future. This study describes the costs of two versions of a PA intervention (an original and a technology-enhanced version) and examines their cost effectiveness in helping sedentary Latina participants reach national PA guidelines. At the beginning of the study, none of the participants were meeting PA guidelines. More participants in the Enhanced intervention, compared to the Original intervention, were meeting guidelines both at 6 months (57% vs. 44%) and 12 months (46% vs. 36%). Costs were also higher for the Enhanced Intervention both at 6 and 12 months. Each additional person meeting guidelines in the Enhanced (vs. Original) group cost $87 at 6 months and $317 at 12 months. Given potential cost savings in medical care associated with meeting PA guidelines, these interventions could ultimately save money in addition to promoting health.

Cost-Effectiveness of Humidified High-Flow Therapy (HHFT) for COPD Patients on Long-Term Oxygen Therapy.

Purpose: 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.

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER), a pragmatic trial for conservative chronic low back pain treatment.

BACKGROUND: 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. METHODS: 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. RESULTS: The SCEPTER trial is currently recruiting and enrolling participants. CONCLUSIONS: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT04142177.

Matching the Outcomes to Treatment Targets of Exercise for Low Back Pain: Does it Make a Difference? Results of Secondary Analyses From Individual Patient Data of Randomised Controlled Trials and Pooling of Results Across Trials in Comparative Meta-analysis.

OBJECTIVE: To explore whether using a single matched or composite outcome might affect the results of previous randomized controlled trials (RCTs) testing exercise for non-specific low back pain (NSLBP). The first objective was to explore whether a single matched outcome generated greater standardized mean differences (SMDs) when compared with the original unmatched primary outcome SMD. The second objective was to explore whether a composite measure, composed of matched outcomes, generated a greater SMD when compared with the original primary outcome SMD. DESIGN: We conducted exploratory secondary analyses of data. SETTING: Seven RCTs were included, of which 2 were based in the USA (University research clinic, Veterans Affairs medical center) and the UK (primary care clinics, nonmedical centers). One each were based in Norway (clinics), Brazil (primary care), and Japan (outpatient clinics). PARTICIPANTS: The first analysis comprised 1) 5 RCTs (n=1033) that used an unmatched primary outcome but included (some) matched outcomes as secondary outcomes, and the second analysis comprised 2) 4 RCTs (n=864) that included multiple matched outcomes by developing composite outcomes (N=1897). INTERVENTION: Exercise compared with no exercise. MAIN OUTCOME MEASURES: The composite consisted of standardized averaged matched outcomes. All analyses replicated the RCTs' primary outcome analyses. RESULTS: Of 5 RCTs, 3 had greater SMDs with matched outcomes (pooled effect SMD 0.30 [95% confidence interval {CI} 0.04, 0.56], P=.02) compared with an unmatched primary outcome (pooled effect SMD 0.19 [95% CI -0.03, 0.40] P=.09). Of 4 composite outcome analyses, 3 RCTs had greater SMDs in the composite outcome (pooled effect SMD 0.28 [95% CI 0.05, 0.51] P=.02) compared with the primary outcome (pooled effect SMD 0.24 [95% CI -0.04, 0.53] P=.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.

Comparing Types of Yoga for Chronic Low Back and Neck Pain in Military Personnel: A Feasibility Randomized Controlled Trial.

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.

Three-Year, Postintervention, Follow-up Comparison of Health Care Resource Utilization and Costs in the Lifestyle Interventions and Independence for Elders (LIFE) Study.

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.

Yoga Practice Among Veterans With and Without Chronic Pain: A Mixed Methods Study.

OBJECTIVES: 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 semistructured 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 vs. 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.

Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans.

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.

Measuring health related quality of life for dengue patients in Iquitos, Peru.

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<0.01). There was substantial heterogeneity in scores during each illness phase with median scores in the early-acute, late-acute and convalescent phases of 0.56 (IQR: 0.41-0.64), 0.70 (IQR: 0.57-0.94), and 1 (IQR: 0.80-1.00), respectively. In all illness phases participants recruited in clinics had on average the lowest HRQoL scores where as those recruited in the contact clusters had the highest. Only 1 individual who was recruited in the contact-clusters had no reduction in HRQoL score during their illness. These data illustrate that dengue should be considered as a disease that may have significant implications for not only physical health but also psychological health and social functioning. The impact of dengue on the HRQoL of non-treatment-seeking individuals, although lower than the impact among treatment-seeking individuals, is not necessarily trivial.

Associations of Coffee and Tea Consumption With Survival to Age 90 Years Among Older Women.

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.

Exploring how different types of yoga change psychological resources and emotional well-being across a single session.

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.

Impact and Lessons From the Lifestyle Interventions and Independence for Elders (LIFE) Clinical Trials of Physical Activity to Prevent Mobility Disability.

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.

Secondary Outcomes from a Randomized Controlled Trial of Yoga for Veterans with Chronic Low-Back Pain.

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.

Rethinking endometriosis care: applying the chronic care model via a multidisciplinary program for the care of women with endometriosis.

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.

Descriptive Usability Study of CirrODS: Clinical Decision and Workflow Support Tool for Management of Patients With Cirrhosis.

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.

Physical Activity and Performance Impact Long-term Quality of Life in Older Adults at Risk for Major Mobility Disability.

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.