6-month Change Research Articles

The outcomes of electronic personal health records in patients with heart failure or coronary artery disease.

There are limited data on the efficacy of smartphone-based personal health records (PHRs) in patients with cardiovascular disease. This study aimed to examine the processes, outcomes and challenges associated with the implementation of integrated PHRs in patients with heart failure (HF) or coronary artery disease (CAD). This prospective single-group study evaluated the effects of a PHR system with the capability to capture electronic health records and vital signs in patients with HF or CAD. The outcomes measured were the 6-month changes in blood pressure (BP), body weight (BW), brain natriuretic peptide (BNP) levels, lipid profiles and haemoglobin (Hb) A1c levels. Between June 2021 and March 2022, we enrolled 111 patients (median age: 61years and 47% women) with CAD and/or HF. Over 6months, the PHR review count distribution was skewed: median 749 times (lowest 2, highest 5724)/180days, suggesting both low and excessive PHR users. After 3days, 23% of the patients discontinued inputting their vital signs and medication status. At 6months, compared with patients who discontinued, those who continued to input their vital signs (N=86) showed a significant decrease in their systolic BP and LDL-C levels but not in the diastolic BP, BW, BNP, HDL-C, triglyceride or HbA1c levels. The implementation of smartphone-based PHRs in daily practice is challenging for patients with HF or CAD. However, we observed positive indications of the benefits of PHR in these patients. UMIN000044369.

Collaborative Care to Improve Quality of Life for Anxiety and Depression in Posttraumatic Epilepsy (CoCarePTE): Protocol for a Randomized Hybrid Effectiveness-Implementation Trial.

Anxiety and depression in people with epilepsy are common and associated with poor outcomes; yet, they often go untreated due to poor mental health specialist access. Collaborative care is an integrated care model with a strong evidence base in primary care and medical settings, but it has not been evaluated in neurology clinics. Evaluating implementation outcomes when translating evidence-based interventions to new clinical settings to inform future scaling and incorporation into real-world practice is important. The Collaborative Care for Posttraumatic Epilepsy (CoCarePTE) trial aims to evaluate the effectiveness (improvement in emotional quality of life) and implementation of a collaborative care intervention for people with anxiety or depressive symptoms and posttraumatic epilepsy. CoCarePTE is a 2-site, randomized, single-blind, hybrid type 1 effectiveness-implementation trial that will randomize 60 adults to receive either neurology-based collaborative care or usual care. Adults receiving neurological care at participating centers with anxiety or depressive symptoms and a history of at least mild traumatic brain injury before epilepsy onset will be enrolled. The collaborative care intervention is a 24-week stepped-care model with video or telephone calls every 2 weeks by a care manager for measurement-based anxiety and depression care, seizure care monitoring, and brief therapy intervention delivery. This is supplemented by antidepressant prescribing recommendations by psychiatrists for neurologists via case conferences and care manager-facilitated team communication. In step 2 of the intervention, individuals with <50% symptom reduction by 10 weeks will receive an added 8-session remote cognitive behavioral therapy program. The study is powered to detect a moderate improvement in emotional quality of life. As a hybrid type 1 trial, effectiveness is the primary focus, with the primary outcome being a change in emotional quality of life at 6 months in the intervention group compared to control. Secondary effectiveness outcomes are 6-month changes in depression, anxiety, and overall quality of life. Implementation outcomes, including fidelity, acceptability, feasibility, and appropriateness, are evaluated before implementation and at 3 months. The primary effectiveness analysis will compare changes in emotional quality of life scores from baseline to 6 months between the intervention and control arms using multiple linear regression modeling, adjusting for study site and using an intent-to-treat approach. Enrollment commenced in 2023, with modifications in the inclusion and exclusion made after the first 6 enrollees due to slow recruitment. Enrollment is expected to continue at least into early 2025. The CoCarePTE trial is novel in its use of a hybrid effectiveness-implementation design to evaluate an evidence-based mental health intervention in epilepsy, and by incorporating seizure care into a collaborative care model. If a significant improvement in emotional quality of life is found in the intervention group compared to usual care, this would support next step scaling or clinical implementation. ClinicalTrials.gov NCT05353452; https://www.clinicaltrials.gov/study/NCT05353452. DERR1-10.2196/59329.

Abstract 4137181: High-Intensity Walking Exercise Minutes and Improved Walking Performance in Peripheral Artery Disease: LITE Randomized Clinical Trial

Background: The LITE randomized clinical trial evaluated the effect of high-intensity vs low-intensity walking exercise on walking ability for peripheral artery disease (PAD). In post-hoc analyses, this study evaluated whether people with PAD who walked more exercise minutes per week had greater six-minute walk (6MW) improvement, compared to those who walked fewer exercise minutes per week. Within each quartile of exercise minutes, change in 6MW was compared between high and low-intensity exercise groups. Methods: People with PAD were randomized to walking exercise that induced ischemic leg symptoms (high-intensity), walking exercise at a comfortable pace without ischemic leg symptoms (low-intensity), or a control group that did not exercise for 12 months. Participants randomized to exercise were asked to walk 5 days/week up to 50 minutes/day. High-intensity exercise was defined and objectively measured using an ActiGraph. Participants wore an ActiGraph during exercise to measure exercise minutes/week. The primary outcome was 12-month change in 6MW. Results: Of 305 PAD participants randomized (47% women, 59% Black), 208 were assigned to exercise and had data available for analyses. The high-intensity exercise group walked fewer exercise minutes/week than the low-intensity exercise group (51.95 vs 136.82, P&lt; 0.0001). In each exercise group, greater exercise minutes/week at target intensity were associated with greater 6MW improvement (Table). Within each quartile of exercise minutes/week, high-intensity exercise improved 6MW significantly more than low-intensity (Table). Conclusion: In the LITE randomized trial, among people randomized to high-intensity and low-intensity exercise, respectively, more minutes of exercise per week were associated with greater 6MW improvement. However, within each quartile of exercise minutes/week, high-intensity exercise improved 6MW significantly more than low-intensity exercise.

A quasi-experimental study assessing the effectiveness of a community-based egg intervention in the nutritional and health status of young children from rural Honduras.

This community-public-private-academic coalition project implemented and evaluated the effectiveness of a rural, community-based egg intervention that aimed to support the nutrition and health of children living in rural, poor communities from Intibucá, Honduras, during the COVID-19 pandemic. This investigator-blind, non-randomized, controlled study was informed by a community health improvement process and participatory research. Women from 13 communities were given a microloan to start an egg farm that supplied 1 egg daily to 201 children ages 6-24 months for 1 year (intervention group). Control communities (n = 14) were selected from neighboring municipalities with similar sociodemographic backgrounds based on size. Sociodemographic-, anthropometric-, and morbidity data were collected biannually between January 2021 to January 2022. Outcome changes were compared with linear-, generalized- or Poisson- mixed models adjusted by sex, age, maternal education, breastfeeding status, assets, adults living at home, baseline outcomes, and community-cluster. Baseline to 6- and 12-month weekly frequency of egg intake significantly increased in the intervention vs. the control group: 6-month change = 1.86; 95%CI (1.61, 2.14); 12-month change = 1.63; 95%CI (1.42, 1.87 p<0.001), respectively. Baseline to 12-month changes in the intervention group were not significant for length/height-for-age-z-scores = 0.12, p = 0.187; weight-for-length/height-z-scores = -0.02, p = 0.78; and diarrhea prevalence, AOR = 1.69; 95%CI (0.53, 5.42), p = 0.378. Lower odds of respiratory infections were observed for the intervention vs. the control group at 6- and 12-month post: AOR = 0.28; 95%CI (0.12, 0.63), p = 0.002; AOR = 0.30; 95%CI (0.12, 0.75), p = 0.010, respectively. Children in the intervention group reported consuming eggs more days per week relative to the control group. Lower odds of respiratory infections were observed in the intervention group throughout the study. Ongoing follow-up will offer more insights on the intervention's effectiveness in linear growth, dietary diversity, food security, and other nutritional outcomes.

High Preoperative Expectations may not Need to be Feared.

Retrospective. Evaluate correlations between preoperative expectations for pain improvement and 12-month functional outcomes and satisfaction following 1-2 level primary anterior cervical surgery. Limited data exists evaluating correlations between patients' preoperative expectations for pain relief and subsequent functional and satisfaction outcomes following primary anterior cervical surgery. Understanding correlations between expectations and outcomes may help identify patients most likely to benefit from surgery. Patients who underwent 1-2 level primary ACDF or CDA for degenerative disease between 2016-2021 were included. All patients had 12-month NDI data. Preoperative expectations for pain relief were collected at the initial clinic visit using 5-point Likert scales. Preoperative and 12-month postoperative satisfaction were recorded using 7-point Likert scales. Covariates including age, gender, procedure type, smoking status, opioid use, worker's compensation/litigation, BMI, and indication (radiculopathy versus myelopathy). Linear regression models were constructed to assess 12-month NDI change score versus pain relief expectations. Additional regression models assessed expectations versus achievement of MCID at 3- and 12-months and satisfaction at 12-months. 198 ACDF (56.1% female, median age 57) and 52 CDR patients (55.8% female, median age 51) were included. Regression models found no significant correlations between pain relief expectations and degree of NDI score improvement at the 12-month postoperative timepoint or MCID achievement at the 3- and 12-month postoperative timepoints. There was no association between preoperative expectations and 12-month satisfaction. However, greater preoperative dissatisfaction was significantly associated with greater 12-month improvement in NDI score. Preoperative pain relief expectations were not associated with functional outcomes or satisfaction following 1-2 level primary ACDF or CDR at 12-month follow-up. Patients' dissatisfaction with their preoperative spinal condition was significantly associated with greater 12-month NDI improvement. Assessing preoperative satisfaction may help identify those most likely to benefit from surgery.

Evaluation of the Stronger Together Peer Mentoring Model Among Patients With Breast and Gynecologic Cancer in Viet Nam.

Stronger Together is a peer mentoring model that seeks to address the severe lack of mental health and psychosocial support for patients with cancer in many low- and middle-income countries (LMICs). This article presents the results of the Stronger Together pilot study among patients with breast and gynecologic cancer in Viet Nam (VN). Eligible participants comprised women age 25 years or older with a diagnosis of breast or gynecologic cancers and receiving treatment at four participating hospitals. Participants were asked whether they wanted to proceed with usual care or be matched with a trained and supervised peer mentor (a cancer survivor). Surveys were administered at baseline (0) and 2, 4, and 6 months and assessed depression, anxiety, stress, mental health and physical health components of quality of life (QOL), self-efficacy, and social support. We computed and compared 2-, 4-, and 6-month changes in scores from baseline and conducted difference-in-difference analyses to estimate the intervention effect at 6 months. The sample size included N = 186 participants. Mentees (n = 91) exhibited improvements in depression, anxiety, stress, and mental health QOL across all time points, whereas usual care participants (n = 95) experienced these improvements at later periods (4 and 6 months). Compared with usual care participants, mentees reported greater improvements in depression at 2 and 4 months, mental health QOL at all time points, and self-efficacy and social support at 4 and 6 months. Greater improvements in stress were also seen in the breast cancer subsample. Stronger Together is a promising model to improve mental health and psychosocial outcomes among patients with breast and gynecologic cancer in VN and can help fill gaps in cancer peer support interventions in many LMICs.

Patients Have Acceptable Patient-Reported Outcome Measures After Medial Unicompartmental Knee Arthroplasty Regardless of Age

BackgroundContemporary evidence-based indications no longer consider age regarding eligibility for medial unicompartmental knee arthroplasty (mUKA). This has led to more surgical candidates; however, whether patients still have satisfactory outcomes lacks evidence. This study examined the association between age and change in patient-reported outcome measures (PROMs) after mUKA as well as the achievement of Patient Acceptable Symptom State (PASS) and Minimal Important Change (MIC). MethodsWe included 782 mUKAs performed between February 1, 2016, and April 26, 2023. The mean change from preoperative Oxford Knee Score (OKS), Forgotten Joint Score (FJS), and Activity and Participation Questionnaire (APQ) was assessed at three, 12, and 24 months after surgery. The achievement of 12-month PASS (OKS ≥ 30) and MIC (changes in OKS ≥ 8; FJS ≥ 14) was also assessed. Patients were divided into age groups: < 55, 55 to < 65, 65 to < 75 years (reference group), and ≥ 75 years. There were 432 women (55%), patients had a mean age of 67 years (range, 29 to 93) and a mean BMI of 30 (range, 20 to 53). ResultsMedian OKS, youngest to eldest, were 34, 35, 36, and 35 (three months); 40, 39, 41, and 43 (12 months); 42, 41, 43, and 42 (24 months). We found no differences in change in OKS between groups. Patients aged 55 to < 65 years had lower changes in FJS at 24 months and APQ at 12 and 24 months. Patients ≥ 75 years had lower 24-month change in APQ. We found no association between age and the fraction achieving either PASS or MIC (youngest to eldest, 90, 90, 94, and 95%). ConclusionWe found good PROM improvements and satisfactory outcomes after mUKA in all age groups; however, patients aged 55 to < 65 years had worse changes in FJS and APQ. Results support contemporary indications for mUKA, and applying an age cutoff is unwarranted.

Low-Magnitude Mechanical Signals to Preserve Skeletal Health in Female Adolescents With Anorexia Nervosa

Malnourished adolescents and young adults with anorexia nervosa (AN) are at high risk for skeletal deficits. To examine whether low-magnitude mechanical signals (LMMS) could preserve bone mineral density (BMD) throughout 6 months in adolescents and young adults with AN. This double-blind, sham-controlled randomized clinical trial, conducted in a hospital-based specialty clinic, assessed female adolescents and young women without medical comorbidity or medication use that would compromise bone health. A total of 837 female adolescents were screened from January 1, 2012, to December 31, 2019, of whom 317 met the study criteria. Data analysis was performed from 2020 to 2024. Platform delivering low-magnitude mechanical signals (LMMS) (0.3 g at 32-37 Hz) or sham (ie, placebo) signals for 10 minutes daily for 6 months. The primary outcome was trabecular volumetric BMD (vBMD) as measured by peripheral quantitative computed tomography of the tibia at baseline and 6 months. Secondary outcomes included cortical vBMD, cross-sectional area (CSA), areal BMD and body composition measured by dual-energy x-ray absorptiometry, and serum bone turnover markers. Forty female adolescents and young women (median [IQR] age, 16.3 [15.1-17.6] years; median [IQR] percentage median BMI for age, 87.2% [81.0%-91.6%]) completed the trial. Total bone vBMD changes were nonsignificant in both groups (95% CI for difference in median change between groups, -57.11 to 2.49): in the LMMS group, vBMD decreased from a median (IQR) of 313.4 (292.9-344.6) to 309.4 (290.4-334.0) mg/cm3, and in the placebo group, it increased from a median (IQR) of 308.5 (276.7-348.0) to 319.2 (309.9-338.4) mg/cm3. Total CSA at the 4% tibia site increased from a median (IQR) of 795.8 (695.0-844.8) mm2 to 827.5 (803.0-839.4) mm2 in the LMMS group, whereas in the placebo group, it decreased from 847.3 (770.5-915.3) mm2 to 843.3 (828.9-857.7) mm2 (95% CI for difference in median change between groups, 2.94-162.53). Median (IQR) trabecular CSA at the 4% tibia site increased from 616.3 (534.8-672.3) mm2 to 649.2 (638.0-661.4) mm2 in the LMMS group but decreased in the placebo group from 686.4 (589.0-740.0) mm2 to 647.9 (637.3-661.9) mm2 (95% CI for difference in median change between groups, 2.80-139.68 mm2). Changes in cortical vBMD, cortical section modulus, and muscle CSA were not significant between groups. The 6-month changes in trabecular and total bone CSA at the tibia 4% site (weight-bearing trabecular bone) were significantly different between groups (these measures increased in the LMMS group but decreased in the placebo group; total bone CSA: 95% CI, 2.94-162.53; P = .01; trabecular CSA: 95% CI, 2.80-139.68; P = .02). Greater increases in body mass index were seen in the placebo group (median [IQR] gain, 0.5 [-0.3 to +2.1]) than in the LMMS group (median [IQR] gain, +0.4 [-0.3 to +2.1]), perhaps due to differences in fat mass accrual. No adverse events occurred related to the LMMS intervention. In this randomized clinical trial of female adolescents and young women with AN, a 6-month LMMS intervention did not yield improvement in tibial trabecular vBMD. However, LMMS led to increases in total and trabecular CSA at the tibia. These results suggest an early positive response of increased bone turnover and trabecular bone quantity due to the LMMS intervention. Future studies should use a longer duration of intervention, consider strategies to optimize adherence, and potentially focus on a more profoundly malnourished patient population. ClinicalTrials.gov Identifier: NCT01100567.

Digital cognitive behavioral therapy vs education for pain in adults with sickle cell disease

AbstractDespite the significant burden of chronic pain in sickle cell disease (SCD), nonpharmacological approaches to manage pain in SCD are lacking. Behavioral interventions incorporating digital cognitive behavioral therapy (CBT) for pain should be compared with available education efforts. This multisite randomized comparative effectiveness trial aimed to compare a CBT intervention tailored for adults with SCD with a digital pain/SCD educational intervention (“Education”) in terms of improving pain and associated symptoms. Participants were recruited virtually from 7 comprehensive SCD centers and community organizations in the United States. Adults (aged ≥18 years) with SCD-related chronic pain and/or daily opioid use were randomly assigned to CBT or Education. Over 12 weeks, the CBT arm received an app-based intervention for pain management; the Education arm received digital pain/SCD education. Both groups received interactive chatbot lessons plus personalized health coach support. Changes in the pain interference scale (primary outcome) and other patient-reported secondary outcomes, including pain intensity, depression, anxiety, quality of life, and self-efficacy, were assessed over 6 months. Of the 453 participants who completed screening, 359 (79%) were randomly assigned to CBT (n = 181) or Education (n = 178), 332 (92%) were Black African American, and 238 were (66.3%) female. At 6 months, 250 (70%) participants (n = 125 per arm) completed follow-up assessments, 93 (26%) missed their follow-up window, and 16 (4%) withdrew. Engagement with the chatbot content was variable (76% connected, 48% completed ≥1 lesson). However, 80% of participants completed ≥1 session with a health coach via phone, video, or text. The 6-month change in pain interference in the CBT (−2.13; 95% confidence interval [CI], −3.42 to −0.84) and Education (−2.66; 95% CI, −3.97 to −1.36) groups was not significantly different (mean difference, 0.54; 95% CI, −1.30 to 2.37; ∗P = ∗.57). Daily pain intensity ratings did not change for either group. There were no between-arm differences in depression, anxiety, quality of life, or the effect of the intervention on pain and mental health in SCD when combined with health coaching. Variable engagement with digital components and high engagement with health coaching may explain the lack of between-group differences, but these findings also provide insights into delivering digital interventions in racial minority and difficult-to-reach populations. This trial was registered at www.clinicaltrials.gov as #NCT04419168.

Impact of eating behavior on 24-month weight change after treatment of severe obesity-A clinical prospective cohort study.

This study aimed to evaluate the effects of self-reported baseline eating behaviors on 24-month weight change in adults with severe obesity. A prospective, nonrandomized clinical cohort study on surgical and medical obesity treatment included 971 adults (75% women) with a mean BMI of 42.0 (SD 4.9) kg/m2. To assess baseline eating behaviors and binge eating disorder, the Questionnaire on Eating and Weight Patterns-Revised and the Three-Factor Eating Questionnaire were used. In analyses adjusted for treatment, age, sex, baseline weight, and BMI, those with nocturnal eating lost less weight (3.5 kg [95% CI: 0.02-6.9]; p < 0.05) at 24 months compared to those without nocturnal eating. Binge eating disorder was not significantly associated with weight loss over 24 months. Emotional eating was associated with less weight loss at 12 months: 1.16 kg per z score (95% CI: 0.37-1.95; p < 0.05). Compared with completers, dropout from medical obesity treatment was associated with emotional and uncontrolled eating at baseline (both p < 0.001). The association between pretreatment eating behaviors and weight change was found to be generalizable and not restricted to any specific treatment. Certain eating behaviors may affect weight loss as well as attrition. Identifying eating behaviors that may impair treatment efficacy are suggested in the treatment of severe obesity.

5124 Increased Copeptin May Reflect Vasopressin-Related Metabolic Changes After Bariatric Surgery

Abstract Disclosure: F. Galbiati: None. A. Aulinas Maso: None. I. Becetti: None. M. Lauze: None. V. Singhal: None. E.A. Lawson: Research Investigator; Self; received research funding and study drug from Tonix Pharmaceuticals. M. Bredella: None. M. Bredella: None. M. Misra: Advisory Board Member; Self; key opinion leader for Lumos Pharma. Consulting Fee; Self; Up To Date, Receives royalties. Objective: Vasopressin (AVP) is a neurohormone that decreases fat mass, promotes muscle regeneration, improves glucose homeostasis, and protects against hypoglycemia in animals and humans. Copeptin, a stable cleavage product of AVP, is positively associated with body mass index (BMI), insulin resistance, and metabolic syndrome in adults, suggesting an adaptive increase in AVP to counteract metabolic disruption. Similarly, copeptin was positively correlated with BMI in children. Metabolic and bariatric surgery (MBS) is highly effective at reducing metabolic complications of obesity, and underlying mechanisms may provide insights into novel therapeutics for obesity management. No study has investigated copeptin pre- and post-MBS in humans. We hypothesized that after MBS, (1) copeptin would increase and (2) increased copeptin would be associated with improved metabolic parameters. Methods: Longitudinal study in 64 adolescents and young adults (78% females; age [mean±SD] 18.7±2.8 years) with obesity (BMI 45.6±6.8 kg/m2). 34 underwent MBS (sleeve gastrectomy or Roux-en-Y gastric bypass) and 30 underwent non-surgical (NS) lifestyle management. We measured fasting circulating copeptin, %fat, and lean mass by dual-energy X-ray absorptiometry, hemoglobin A1c (HbA1c), and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at baseline and 12 months. Results: Groups were similar for age, sex, race, and pubertal stage. Baseline BMI and %fat were higher in MBS (p≤.012). Baseline copeptin, %lean mass, HbA1c, and HOMA-IR did not differ across groups (p≥.103). MBS vs NS 12-month changes were [median(IQR)]: BMI -29.0 (-33.7, -16.5)% and 0.54 (-3.10, +4.37)%; %fat -8.03 (-13.33, -4.25) and -0.68 (-2.92, 0.64); %lean mass 7.73 (3.45, 12.38) and 0.83 (-.58, 2.73); HbA1c -0.40 (-0.52, -0.20) and -0.10 (-0.20, -0.02); HOMA-IR (mean±SD) -2.47±2.17 and 0.76±2.42 (ps≤.001). Baseline copeptin was correlated negatively with %fat (rho=-.25; p=.045), and positively with %lean mass (trend-level rho=.25, p=0.051). Copeptin increased in the MBS group and decreased in the NS group (time-x;-treatment effect: p=.017). Overall, copeptin change was correlated negatively with %fat change (rho=-.29; p=.025) and positively with %lean mass change (trend-level rho=0.24, p=.070). Copeptin change was positively correlated with changes in %lean mass (rho=.37, p=.045), HbA1c (rho=.46; p=.010), and HOMA-IR (rho=.53; p=.004), only after MBS. Conclusion: Overall, increase in copeptin over 12 months was associated with improved body composition, suggesting that increased AVP following MBS may contribute to its associated metabolic improvements. However, within the MBS group, improved glucose homeostasis was associated with reductions in copeptin, suggesting a possible protective mechanism against post-bariatric hypoglycemia. Presentation: 6/2/2024

Evaluation of topical bromfenac as an adjunctive treatment with intravitreal ranibizumab in the management of diabetic macular edema

Background and purpose Intravitreal injection of anti- vascular endothelial growth factor medications has transformed the therapy of diabetic macular edema (DME). The purpose of this study was to evaluate the safety and efficacy of topical bromfenac as an adjunctive therapy to intravitreal ranibizumab injections in patients diagnosed with DME. Study design Prospective, randomized, controlled clinical trial. Patients The study included 40 eyes of patients with DME, divided into two groups: group I (20 eyes) received intravitreal ranibizumab injections and adjunctive topical bromfenac twice daily; group II (20 eyes) received only intravitreal ranibizumab injections. Methods All patients underwent assessments for best corrected visual acuity (BCVA), intraocular pressure, anterior segment, and fundus examination. Optical coherence tomography of the macula was repeated at 1, 3, and 6 months after the last injection. Results At 6 months, group I demonstrated significantly worse BCVA compared with group II (P=0.021). In group II, the 6-month change in central macular thickness from baseline was significantly greater in patients aged less than or equal to 60 years compared with those greater than 60 years (median = –170.5 μm vs. −40 μm, respectively; P=0.001) and in females compared with males (median = –75 μm vs. −23.4 μm; P=0.012). No significant differences were observed concerning the duration of diabetes (P=0.238), HbA1c levels (P=0.315), or laterality (P=0.792). Conclusion Topical bromfenac, when combined with intravitreal ranibizumab, showed some efficacy in the management of DME over a 6-month follow-up period, although the results were not statistically significant.

Changes in Use of Migraine Medications, Healthcare Resource Utilization, and Associated Direct Costs Over 12Months Following Initiation of Erenumab: A US Retrospective Real-World Analysis.

Erenumab-aooe is approved for the preventive treatment of migraine in adults. Recent publications have evaluated migraine medication use during the 6 months after starting erenumab, but longer-term follow-up data are limited. The objective of this study was to describe 12-month medication use and changes in healthcare resource utilization (HRU) and associated direct costs among patients initiating erenumab. We identified adult patients with an erenumab claim in the Merative MarketScan Commercial and Medicare Databases from May 2018 through September 2019. Eligible patients had ≥ 12months of continuous medical and pharmacy coverage before (pre-index period) and after (post-index period) the index date (first erenumab claim) in addition to pre-index evidence of migraine. Patients were stratified by post-index-period adherence to erenumab, defined as ≥ 80% of days covered (adherent) or < 80% of days covered (non-adherent). Outcomes were measured pre- and post-index, and differences between these periods were described. Among 7528 eligible patients, the mean (standard deviation) age was 45.1 (11.4) years and 85.4% were female; 38.5% of patients were adherent to erenumab. Most patients used acute or traditional migraine-preventive medications pre-index, with reductions in use observed post-index (acute medication was used by 95.6% of patients pre-index, compared to 92.3% post-index; traditional preventive medication was used by 89.6% of patients pre-index, compared to 81.9% post-index). Reductions were observed for HRU of emergency room visits (-3.8%) and brain- and other head-imaging studies (-7.5%). Overall costs associated with acute and traditional preventive medications were reduced (-$764), but costs for HRU increased slightly ($76). When stratifying by adherence and combining costs for acute and traditional preventive medications and HRU, adherent patients had cost decreases (-$1947), while non-adherent patients had cost increases ($101). Most patients initiating erenumab had prior use of acute and traditional migraine-preventive therapies. The reduction in acute and traditional migraine-preventive medication use and HRU over the 12-month follow-up supports the long-term clinical benefits of erenumab in the real-world setting.

Impact of a post-lifestyle modification program in circulating angiopoietin-like proteins in Arab adolescents

This study investigated the differences and associations between serum levels of angiopoietin-like (ANGPTL)3, ANGPTL4, and ANGPTL8 in Saudi adolescents with varying levels of obesity and glycemia before and after undergoing a 12-month lifestyle change intervention. A total of 218 Saudi adolescents (45 normal, 77 overweight, and 96 obese) (mean age = 15.1 ± 1.5 years; mean BMI = 35.1 ± 6.6 kg/m2) were included. Anthropometrics were measured at baseline and follow-up. Overnight-fasting serum samples were also collected at baseline and after 12 months of intervention for routine analysis of fasting glucose, glycated hemoglobin (HbA1c) and lipid profile. Serum levels of insulin and ANGPTLs were assessed using commercial assays. At baseline, obese children had a higher ANGPTL8 level [0.7 ng/ml (0.4–1.3), p = 0.03]. In children with prediabetes (defined as those with HbA1c > 5.7), ANGPTL8 levels and HbA1c were significantly lower post-intervention [0.2 (0.1–0.8), p = 0.002; 5.5 ± 1.1), p < 0.001, respectively]. Follow-up lipid profile and insulin levels were significantly higher in all participants with prediabetes and obesity (p-values < 0.05). ANGPTL8 levels of those who achieved 5 % weight loss (N = 25) showed no difference after follow-up (p = 0.59). In conclusion, following a 12-month lifestyle modification program, decreased levels of circulating ANGPTL8 were observed in adolescents with obesity and prediabetes. Consequently, the degree of insulin resistance may be improved by reducing reduced ANGPTL8 levels.

Endovascular treatment in ischemic strokes with large infarct core: an updated systematic review and meta-analysis of randomized controlled trials.

Endovascular treatment (EVT) is recommended for acute ischemic stroke due to large-vessel occlusion (LVO) and an ASPECTs ≥ 6. Recent randomized controlled trials (RCTs) have become available on effect of EVT in patients with LVO-related large core infarct stroke (ASPECTS 0-5). We conducted a systematic review and meta-analysis of trials on patients with large core infarct treated with thrombectomy compared to best medical therapy (BMT). The study followed PRISMA guidelines. Primary endpoint was functional independence at 90days (modified Rankin Scale mRS < 3). Secondary endpoints were 3-month moderate disability (mRS < 4), excellent outcome (mRS < 2) and change in mRS (shift analysis). Safety outcomes were: symptomatic intracranial hemorrhage (sICH) and 3-month mortality. Seven RCTs were included with a total of 1964 patients. Functional independence was significantly more frequent in EVT vs BMT group (19.4% vs 8%; OR = 2.72, 95%CI = 2.06-3.61, pheterogeneity = 0.08; I2: 47%). Moderate outcome was also more prevalent in EVT group (OR = 2.00; 95%CI = 1.61 - 2.48, pheterogeneity = 0.17; I2: 46%) as well as excellent outcome (OR: 1.54, 95%CI = 1.07 - 2.22, pheterogeneity = 0.13; I2: 40%). Shift analysis was also significant with OR 1.59 (CI = 1.33-1.82 and p < 0.001). Finally sICH, that occurred in 68 patients, was more frequent in EVT (OR = 1.63, 95%CI = 0.99 - 2.69, pheterogeneity = 0.68; I2: 0%) while 3m mortality was reduced in EVT (31% vs 37,1%, OR 0.76 CI = 0.62-0.92). This updated pooled data show that, in LVO-stroke patients with a large core infarct, EVT plus BMT (as compared to BMT alone) increases significantly the chances of achieving a good functional outcome at 90days and reduces the 3- month mortality despite a marginal increase in acute sICH.

The LEAP2 Response to Cancer-Related Anorexia-Cachexia Syndrome in Male Mice and Patients.

The hormone ghrelin serves a protective role in cancer-related anorexia-cachexia syndrome (CACS)-a condition in which plasma levels of ghrelin rise, its administration lessens CACS severity, and experimentally reduced signaling by its receptor (GHSR) worsens fat loss and anorexia and accelerates death. Yet, actions for the related hormone liver-expressed antimicrobial peptide-2 (LEAP2), which is an endogenous GHSR antagonist, are unexplored in CACS. Here, we found that plasma LEAP2 and LEAP2/ghrelin ratio were lower in Lewis lung carcinoma (LLC) and RM-9 prostate cancer CACS mouse models. Ghrelin deletion exaggerated losses of tumor-free body weight and fat mass, reduced food intake, reduced soleus muscle weight, and/or lowered grip strength in LLC or RM-9 tumor-bearing mice. LEAP2 deletion lessened reductions in tumor-free body weight and fat mass and increased food intake in LLC or RM-9 tumor-bearing mice. In a 55-subject cohort of patients with CACS or weight-stable cancer, the plasma LEAP2/total ghrelin ratio was negatively correlated with 6-month weight change preceding blood collection. These data demonstrate that ghrelin deletion exacerbates CACS in the LLC and RM-9 tumor-bearing mouse models while contrastingly, LEAP2 deletion reduces measures of CACS in these tumor-bearing mouse models. Further, they suggest that lower plasma LEAP2/ghrelin ratio protects against worsened CACS.

Volumetric muscle composition analysis in sporadic inclusion body myositis using fat-referenced magnetic resonance imaging: Disease pattern, repeatability, and natural progression.

Fat-referenced magnetic resonance imaging (MRI) has emerged as a promising volumetric technique for measuring muscular volume and fat in neuromuscular disorders, but the experience in inflammatory myopathies remains limited. Therefore, this work aimed at describing how sporadic inclusion body myositis (sIBM) manifests on standardized volumetric fat-referenced MRI muscle measurements, including within-scanner repeatability, natural progression rate, and relationship to clinical parameters. Ten sIBM patients underwent whole-leg Dixon MRI at baseline (test-retest) and after 12 months. The lean muscle volume (LMV), muscle fat fraction (MFF), and muscle fat infiltration (MFI) of the quadriceps, hamstrings, adductors, medial gastrocnemius, and tibialis anterior were computed. Clinical assessments of IBM Functional Rating Scale (IBMFRS) and knee extension strength were also performed. The baseline test-retest MRI measurements were used to estimate the within-subject standard deviation (sw). 12-month changes were derived for all parameters. The MRI measurements showed high repeatability in all muscles; sw ranged from 2.7 to 18.0 mL for LMV, 0.7-1.3 percentage points (pp) for MFF, and 0.2-0.7 pp for MFI. Over 12 months, average LMV decreased by 7.4% while MFF and MFI increased by 3.8 pp and 1.8 pp, respectively. Mean IBMFRS decreased by 2.4 and mean knee extension strength decreased by 32.8 N. The MRI measurements showed high repeatability and 12-month changes consistent with muscle atrophy and fat replacement as well as a decrease in both muscle strength and IBMFRS. Our findings suggest that fat-referenced MRI measurements are suitable for assessing disease progression and treatment response in inflammatory myopathies.

Effect of Denosumab or Alendronate on Vascular Calcification: Secondary Analysis of SALTIRE2 Randomized Controlled Trial.

Patients with osteoporosis demonstrate increased vascular calcification but the effect of osteoporosis treatments on vascular calcification remains unclear. The present study aimed to examine whether coronary or aortic calcification are influenced by denosumab and alendronic acid treatment. In a double-blind randomized controlled SALTIRE2 (Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis) trial, patients with aortic stenosis were randomized 2:1:2:1 to denosumab, placebo injection, alendronic acid, or placebo capsule. Participants underwent serial imaging with computed tomography and 18F-sodium fluoride positron emission tomography for the assessment of vascular calcium burden and calcification activity, respectively. We report the prespecified secondary analyses of 24-month change in coronary calcium score, and 12-month changes in thoracic aorta calcium score, coronary and aortic 18F-sodium fluoride activity. One hundred fifty patients with aortic stenosis (72±8 years; 21% female) were randomized to denosumab (n=49), alendronic acid (n=51), and placebo (injection n=25, capsule n=25). There were no differences in change in coronary calcium scores between placebo (16 [-64 to 148] Agatston units) and either denosumab (94 [0-212] Agatston units, P=0.24) or alendronic acid (34 [-62 to 134], P=0.99). There were no differences in change in thoracic aorta calcium scores between placebo (132 [22-512] Agatston units) and either denosumab (118 [11-340], P=0.75) or alendronic acid (116 [26-498] Agatston units, P=0.62). There were no differences in changes in coronary or aortic 18F-sodium fluoride activity between treatment groups. Neither alendronic acid nor denosumab are associated with changes in the activity or progression of coronary or aortic calcification. Osteoporosis treatments do not appear to have major impact on vascular calcification of atherosclerosis. https://www.clinicaltrials.gov; Unique identifier: NCT02132026.

Short-term effects of a park-based group mobility program on increasing outdoor walking in older adults with difficulty walking outdoors: the Getting Older Adults Outdoors (GO-OUT) randomized controlled trial

BackgroundWe estimated the short-term effects of an educational workshop and 10-week outdoor walk group (OWG) compared to the workshop and 10 weekly reminders (WR) on increasing outdoor walking (primary outcome) and walking capacity, health-promoting behavior, and successful aging defined by engagement in meaningful activities and well-being (secondary outcomes) in older adults with difficulty walking outdoors.MethodsIn a 4-site, parallel-group randomized controlled trial, two cohorts of community-living older adults (≥ 65 years) reporting difficulty walking outdoors participated. Following a 1-day workshop, participants were stratified and randomized to a 10-week OWG in parks or 10 telephone WR reinforcing workshop content. Masked evaluations occurred at 0, 3, and 5.5 months. We modeled minutes walked outdoors (derived from accelerometry and global positioning system data) using zero-inflated negative binomial regression with log link function, imputing for missing observations. We modeled non-imputed composite measures of walking capacity, health-promoting behavior, and successful aging using generalized linear models with general estimating equations based on a normal distribution and an unstructured correlation matrix. Analyses were adjusted for site, participation on own or with a partner, and cohort.ResultsWe randomized 190 people to the OWG (n = 98) and WR interventions (n = 92). At 0, 3, and 5.5 months, median outdoor walking minutes was 22.56, 13.04, and 0 in the OWG, and 24.00, 26.07, and 0 in the WR group, respectively. There was no difference between groups in change from baseline in minutes walked outdoors based on incidence rate ratio (IRR) and 95% confidence interval (CI) at 3 months (IRR = 0.74, 95% CI 0.47, 1.14) and 5.5 months (IRR = 0.77, 95% CI 0.44, 1.34). Greater 0 to 3-month change in walking capacity was observed in the OWG compared to the WR group (βz-scored difference = 0.14, 95% CI 0.02, 0.26) driven by significant improvement in walking self-efficacy; other comparisons were not significant.ConclusionsA group, park-based OWG was not superior to WR in increasing outdoor walking activity, health-promoting behavior or successful aging in older adults with difficulty walking outdoors; however, the OWG was superior to telephone WR in improving walking capacity through an increase in walking self-efficacy. Community implementation of the OWG is discussed.Trial registrationClinicalTrials.gov NCT03292510 Date of registration: September 25, 2017.

Adiposity and Muscle Strength in Men With Prostate Cancer and Cardiovascular Outcomes

BackgroundThere are limited data on the physical effects of androgen deprivation therapy (ADT) for prostate cancer (PC), and on the relationships of such measures of adiposity and strength to cardiovascular outcomes. ObjectivesThe primary objective of this study was to evaluate the relationships of measures of adiposity and strength to cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, peripheral arterial disease, and venous thromboembolism) in patients with PC. A secondary objective was to characterize the relationships between ADT use and 12-month changes in these physical measures. MethodsThis international, prospective cohort study included 3,967 patients with PC diagnosed in the prior 12 months or being treated with ADT for the first time. Median follow-up duration was 2.3 years. ResultsParticipants’ mean age was 68.5 years, and 1,731 (43.6%) were exposed to ADT. ADT was associated with a 1.6% increase in weight, a 2.2% increase in waist circumference, a 1.6% increase in hip circumference, a 0.1% increase in waist-to-hip ratio, a 27.4% reduction in handgrip strength, and a 0.1% decrease in gait speed. High waist circumference and low handgrip strength were associated with adverse cardiovascular outcomes. Adjusting for age, education, race, tobacco and alcohol use, physical activity, cardiovascular disease, glomerular filtration rate, and ADT use, waist circumference above the highest quartile (110 cm) and handgrip strength below the lowest quartile (29.5 kg) were associated with higher likelihoods of a future cardiovascular event, with respective HRs of 1.40 (95% CI: 1.03-1.90; P = 0.029) and 1.59 (95% CI: 1.14-2.22; P = 0.006). ConclusionsADT was associated with increased adiposity and reduced strength over 12-month follow-up. High waist circumference and low baseline strength were associated with future adverse cardiovascular outcomes.