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Introduction: Pennsylvania opened its first medical marijuana (MMJ) dispensary in 2018. Qualifying conditions include six conditions determined to have no or insufficient evidence to support or refute MMJ effectiveness. We conducted a study to describe MMJ dispensary access in Pennsylvania and to determine whether dispensary proximity was associated with MMJ certifications and community demographics. Methods: Using data from the Pennsylvania Department of Health, we geocoded MMJ dispensary locations and linked them to US Census Bureau data. We created dispensary access measures from the population-weighted centroid of Zip Code Tabulation Areas (ZCTAs): distance to nearest dispensary and density of dispensaries within a 15-min drive. We evaluated associations between dispensary access and the proportion of adults who received MMJ certification and the proportion of certifications for low evidence conditions (amyotrophic lateral sclerosis, epilepsy, glaucoma, Huntington's disease, opioid use disorder, and Parkinson's disease) using negative binomial modeling, adjusting for community features. To evaluate associations racial and ethnic composition of communities and distance to nearest dispensary, we used logistic regression to estimate the odds ratios (OR) and 95% confidence intervals (CI), adjusting for median income. Results: Distance and density of MMJ dispensaries were associated with the proportion of the ZCTA population certified and the proportion of certifications for insufficient evidence conditions. Compared to ZCTAs with no dispensary within 15 min, the proportion of adults certified increased by up to 31% and the proportion of certifications for insufficient evidence decreased by up to 22% for ZCTAs with two dispensaries. From 2018 to 2021, the odds of being within five miles of a dispensary was up to 20 times higher in ZCTAs with the highest proportions of individuals who were not White (2019: OR: 20.14, CI: 10.7–37.8) and more than double in ZCTAs with the highest proportion of Hispanic individuals (2018: OR: 2.81, CI: 1.51–5.24), compared to ZCTAs with the lowest proportions. Conclusions: Greater dispensary access was associated with the proportions of certified residents and certifications for low evidence conditions. Whether these patterns are due to differences in accessibility or demand is unknown. Associations between community demographics and dispensary proximity may indicate MMJ access differences. [ABSTRACT FROM AUTHOR]

Background: Lisfranc fracture-dislocation is an uncommon but serious injury that currently lacks universal consensus on optimal operative treatment. Two common fixation methods are open reduction and internal fixation (ORIF) and primary arthrodesis (PA). The objective of this study is to analyze the cost difference between ORIF and PA of Lisfranc injuries, along with the contribution of medical services to overall costs. Methods: This was a retrospective cost analysis of the MarketScan database from 2010 to 2020. MarketScan is an insurance and commercial claims database that integrates deidentified patient information. It captures person-specific clinical utilization, expenditures, and enrollment across inpatient and outpatient services. Patients undergoing primary ORIF (CPT code 28615) vs PA (28730 and 28740) for Lisfranc fracture-dislocation were identified. The primary independent variable was ORIF vs PA of Lisfranc injury. Total costs due to operative management was the primary objective. The utilization of and costs contributed by medical services was a secondary outcome. Results: From 2010 to 2020, a total of 7268 patients underwent operative management of Lisfranc injuries, with 5689 (78.3%) ORIF and 1579 (21.7%) PA. PA was independently associated with increased net and total payment and coinsurance, clinic visits, and imaging, and patients attended significantly more PT sessions. Conclusion: Using this large database that does not characterize severity or extent of injury, we found that treatment of Lisfranc fracture-dislocation with ORIF was associated with substantially lower initial episode of treatment costs compared with PA. Specific excessive cost drivers for PA were clinic visits, PT sessions, and imaging. [ABSTRACT FROM AUTHOR]

Background: A common method of pain assessment is the numerical rating scale, where patients are asked to rate their pain on a scale from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine". We hypothesize such language is suboptimal as it involves a test of a cognitive skill, imagination, in the assessment of symptom severity. Methods: We used a large-scale online research registry, ResearchMatch, to conduct a randomized controlled trial to compare the distributions of pain scores of two different pain scale anchors. We recruited adults located in the United States who reported a chronic pain problem (> 3 months) and were currently in pain. Participants were randomized in a 1:1 ratio to receive pain assessment based on a modified Brief Pain Inventory (BPI), where the anchor for a score of 10 was either "extremely severe pain", or the original BPI, with the anchor "pain as bad as you can imagine". Participants in both groups also answered additional questions about pain, other symptomatology and creativity. Results: Data were obtained from 405 participants for the modified and 424 for the original BPI. Distribution of responses to pain questions were similar between groups (all p-values ≥ 0.12). We did not see evidence that the relationship between pain score and the anchor text differed based on self-perceived creativity (all interaction p-values ≥ 0.2). However, in the key analysis, correlations between current pain assessments and known correlates (fatigue, anxiety, depression, current pain compared to a typical day, pain compared to other people) were stronger for "extreme" vs. "imaginable" anchor text (p = 0.005). Conclusion: Pain rating scales should utilize the modified anchor text "extremely severe pain" instead of "pain as bad as you can imagine". Further research should explore the effects of anchors for other symptoms. [ABSTRACT FROM AUTHOR]

Extensive media coverage and potential controversy about COVID-19 vaccination during the pandemic may have affected people's general attitudes towards vaccination. We sought to describe key psychological antecedents related to vaccination and assess how these vary temporally in relationship to the pandemic and availability of COVID-19 vaccination. As part of an ongoing online study, we recruited a national (U.S.) sample of young gay, bisexual and other men who have sex with men (N = 1,227) between October 2019 and June 2021, and assessed the "4Cs" (antecedents of vaccination; range = 1–5). Overall, men had high levels of confidence (trust in vaccines; M = 4.13), calculation (deliberation; M = 3.97) and collective responsibility (protecting others; M = 4.05) and low levels of complacency (not perceiving disease risk; M = 1.72). In multivariable analyses, confidence and collective responsibility varied relative to the pandemic phase/vaccine availability, reflecting greater hesitancy during later stages of the pandemic. Antecedents also varied by demographic characteristics. Findings suggest negative effects of the COVID-19 pandemic on key antecedents of general vaccination and identify potential targets for interventions. [ABSTRACT FROM AUTHOR]

Few studies have assessed the association between endogenous steroid hormone levels and a subsequent diagnosis of endometriosis. We prospectively evaluated premenopausal plasma sex hormone levels and the risk of laparoscopically confirmed endometriosis in a nested case-control study within Nurses' Health Study II. Between blood collection (1996–1999) and 2009, we ascertained 446 women with incident endometriosis and matched them to 878 controls through risk-set sampling. We conducted multivariable conditional logistic regression accounting for matching and confounders to estimate relative risks (RRs) and 95% confidence intervals (CIs). Women with greater early follicular-phase total or free estradiol levels had a nonlinear increased risk of endometriosis (early follicular total estradiol: second quartile vs. first, RR = 2.23 (95% CI: 1.44, 3.47); third quartile, RR = 1.83 (95% CI: 1.16, 2.88); fourth quartile, RR = 1.68 (95% CI: 1.05, 2.68); early follicular free estradiol: second quartile vs. first, RR = 1.63 (95% CI: 1.05, 2.54); third quartile, RR = 2.02 (95% CI: 1.31, 3.12); fourth quartile, RR = 1.04 (95% CI: 0.66, 1.65)). Free testosterone assessed in quartile categories was not associated with endometriosis, although a threshold effect was observed, with a positive association among women in the top 2% of free testosterone levels. Levels of mid–luteal-phase total and free estradiol, follicular and luteal estrone, total testosterone, progesterone, and sex hormone binding globulin were not associated with endometriosis risk. These results support the role of sex steroids in endometriosis etiology, although the relationships suggest complex threshold effects. [ABSTRACT FROM AUTHOR]

Introduction: After discharge from the emergency department (ED), pain management challenges parents, who have been shown to undertreat their children's pain. Our goal was to evaluate the effectiveness of a five-minute instructional video for parents on pain treatment in the home setting to address common misconceptions about home pediatric pain management. Methods: We conducted a randomized, single-blinded clinical trial of parents of children ages 1-18 years who presented with a painful condition, were evaluated, and were discharged home from a large, tertiary care pediatric ED. Parents were randomized to a pain management intervention video or an injury prevention control video. The primary outcome was the proportion of parents that gave their child pain medication at home after discharge. These data were recorded in a home pain diary and analyzed using the chi square test to determine significant difference. Parents' knowledge about components of at-home pain treatment were tested before, immediately following, and two days after intervention. We used McNemar's test statistic to compare incorrect pretest/correct post-test answers between intervention and control groups. Results: A total of 100 parents were enrolled: 59 parents watched the pain education video, and 41 the control video. Overall, 75% of parents completed follow-up, providing information about home medication use. Significantly more parents provided pain medication to their children after watching the educational video: 96% vs 80% (difference 16%; 95% CI 7.8-31.3%). Significantly more parents had correct pain treatment knowledge immediately following the educational video about pain scores (P = 0.04); the positive effects of analgesics (P <0.01); and pain medication misconceptions (P = 0.02). Most differences in knowledge remained two days after the video intervention. Conclusion: The five-minute educational video about home pain treatment viewed by parents in the ED prior to discharge significantly increased the proportion of children receiving pain medication at home as well as parents' knowledge about at-home pain management. [ABSTRACT FROM AUTHOR]

Background: Achilles tendon rupture (ATR) is a common injury with a growing incidence rate. Treatment is either operative or nonoperative. However, evidence is lacking on the cost comparison between these modalities. The objective of this study is to investigate the cost differences between operative and nonoperative treatment of ATR using a large national database. Methods: Patients who received treatment for an ATR were abstracted from the large national commercial insurance claims database, Marketscan Commercial Claims and Encounters Database (n = 100 825) and divided into nonoperative (n = 75 731) and operative (n = 25 094) cohorts. Demographics, location, and health care charges were compared using multivariable regression analysis. Subanalysis of costs for medical services including clinic visits, imaging studies, opioid usage, and physical therapy were conducted. Patients who underwent secondary repair were excluded. Results: Operative treatment was associated with increased net and total payments, coinsurance, copayment, deductible, coordination of benefits (COB) / savings, greater number of clinic visits, radiographs, magnetic resonance imaging (MRI) scans, and physical therapy (PT) sessions, and with higher net costs due to clinic visits, radiographs, MRIs, and PT (P <.001). Operative repair at an ambulatory surgical center was associated with a lower net and total payment, and a significantly higher deductible compared to in-hospital settings (P <.001). Both cohorts received similar numbers of opioid prescriptions during the study period. Yet, operative patients had a significantly shorter duration of opioid use. After controlling for confounders, operative repair was also independently associated with lower net costs due to opioid prescriptions. Conclusion: Compared with nonoperatively managed ATR, surgical repair is associated with greater costs partially because of greater utilization of clinic visits, imaging, and physical therapy sessions. However, surgical costs may be reduced when procedures are performed in ambulatory surgery centers vs hospital facilities. Nonoperative treatment is associated with higher prescription costs secondary to longer duration of opioid use. Level of Evidence: Level III, retrospective cohort study. [ABSTRACT FROM AUTHOR]

Simple Summary: Abiraterone acetate and enzalutamide are novel therapies used in advanced prostate cancer. However, their outcomes and toxicities may differ based on patient–specific factors. Understanding these differences may allow clinicians to make personalized treatment decisions based on individual patients. Because clinical trials do not represent the real-world population, this study used a formal protocol to review and collate smaller, real-world samples, aiming to explain the differences in outcomes following administration of these two drugs. We found that enzalutamide typically has improved cancer response and overall survival. Enzalutamide more commonly causes neurological side effects and fatigue, while abiraterone acetate has cardiovascular complications. Abiraterone acetate leads to increased costs and healthcare needs, including hospitalizations and emergency room visits. Ultimately, this study demonstrates significant differences in patient experiences and outcomes following abiraterone acetate versus enzalutamide. Clinicians may use this information to inform their treatment choice on a patient-specific basis. Abiraterone acetate (AA) and enzalutamide (ENZ) are commonly used for metastatic prostate cancer. It is unclear how their outcomes and toxicities vary with patient-specific factors because clinical trials typically exclude patients with significant comorbidities. This study aims to fill this knowledge gap and facilitate informed treatment decision making. A registered protocol utilizing PRISMA scoping review methodology was utilized to identify real-world studies. Of 433 non-duplicated publications, 23 were selected by three independent reviewers. ENZ offered a faster and more frequent biochemical response (30–50% vs. 70–75%), slowed progression (HR 0.66; 95% CI 0.50–0.88), and improved overall survival versus AA. ENZ was associated with more fatigue and neurological adverse effects. Conversely, AA increased risk of cardiovascular- (HR 1.82; 95% CI 1.09–3.05) and heart failure-related (HR 2.88; 95% CI 1.09–7.63) hospitalizations. Ultimately, AA was associated with increased length of hospital stay, emergency department visits, and hospitalizations (HR 1.26; 95% CI 1.04–1.53). Accordingly, total costs were higher for AA, although pharmacy costs alone were higher for ENZ. Existing data suggest that AA and ENZ have important differences in outcomes including toxicities, response, disease progression, and survival. Additionally, adherence, healthcare utilization, and costs differ. Further investigation is warranted to inform treatment decisions which optimize patient outcomes. [ABSTRACT FROM AUTHOR]

Objective: To determine whether initiating saline nasal irrigation after COVID-19 diagnosis reduces hospitalization and death in high-risk outpatients compared with observational controls, and if irrigant composition impacts severity. Methods: Participants 55 and older were enrolled within 24 hours of a + PCR COVID-19 test between September 24 and December 21, 2020. Among 826 screened, 79 participants were enrolled and randomly assigned to add 2.5 mL povidone-iodine 10% or 2.5 mL sodium bicarbonate to 240 mL of isotonic nasal irrigation twice daily for 14 days. The primary outcome was hospitalization or death from COVID-19 within 28 days of enrollment by daily self-report confirmed with phone calls and hospital records, compared to the CDC Surveillance Dataset covering the same time. Secondary outcomes compared symptom resolution by irrigant additive. Results: Seventy-nine high-risk participants were enrolled (mean [SD] age, 64 [8] years; 36 [46%] women; 71% Non-Hispanic White), with mean BMI 30.3. Analyzed by intention-to-treat, by day 28, COVID-19 symptoms resulted in one ED visit and no hospitalizations in 42 irrigating with alkalinization, one hospitalization of 37 in the povidone-iodine group, (1.27%) and no deaths. Of nearly three million CDC cases, 9.47% were known to be hospitalized, with an additional 1.5% mortality in those without hospitalization data. Age, sex, and percentage with pre-existing conditions did not significantly differ by exact binomial test from the CDC dataset, while reported race and hospitalization rate did. The total risk of hospitalization or death (11%) was 8.57 times that of enrolled nasal irrigation participants (SE = 2.74; P =.006). Sixty-two participants completed daily surveys (78%), averaging 1.8 irrigations/day. Eleven reported irrigation-related complaints and four discontinued use. Symptom resolution was more likely for those reporting twice daily irrigation (X 2 = 8.728, P =.0031) regardless of additive. Conclusion: SARS-CoV-2+ participants initiating nasal irrigation were over 8 times less likely to be hospitalized than the national rate. [ABSTRACT FROM AUTHOR]

Background: Improving care transitions following emergency department (ED) visits may reduce post‐ED adverse events among older adults (e.g., ED revisits, decreased function). The Care Transitions Intervention (CTI) improves hospital‐to‐home transitions; however, its effectiveness at improving post‐ED outcomes is unknown. We tested the effectiveness of the CTI with community‐dwelling older adult ED patients, hypothesizing that it would reduce revisits and increase performance of self‐management behaviors during the 30 days following discharge. Methods: We conducted a randomized controlled trial among patients age ≥ 60 discharged home from one of three EDs in two states. Intervention participants received a minimally modified CTI, with a home visit 24 to 72 h postdischarge and one to three phone calls over 28 days. We collected demographic, health status, and psychosocial data at the initial ED visit. Medication adherence and knowledge of red flag symptoms were assessed via phone survey. Care use and comorbidities were abstracted from medical records. We performed multivariate regressions for intention‐to‐treat and per‐protocol (PP) analyses. Results: Participant characteristics (N = 1,756) were similar across groups: mean age 72.4 ± 8.6 years and 53% female. Of those randomized to the intervention, 84% completed the home visit. Overall, 12.4% of participants returned to the ED within 30 days. The CTI did not significantly affect odds of 30‐day ED revisits (adjusted odds ratio [AOR] = 0.97, 95% confidence interval [CI] = 0.72 to 1.30) or medication adherence (AOR = 0.89, 95% CI = 0.60 to 1.32). Participants receiving the CTI (PP) had increased odds of in‐person follow‐up with outpatient clinicians during the week following discharge (AOR = 1.24, 95% CI = 1.01 to 1.51) and recalling at least one red flag from ED discharge instructions (AOR = 1.34 95% CI = 1.05 to 1.71). Conclusions: The CTI did not reduce 30‐day ED revisits but did significantly increase key care transition behaviors (outpatient follow‐up, red flag knowledge). Additional research is needed to explore if patients with different conditions benefit more from the CTI and whether decreasing ED revisits is the most appropriate outcome for all older adults. [ABSTRACT FROM AUTHOR]

Background: Prior studies have assessed provider knowledge and factors associated with opioid misuse; similar studies evaluating patient knowledge are lacking. The purpose of this study was to assess the degree of understanding regarding opioid use in orthopaedic trauma patients. We also sought to determine the demographic factors and clinical and personal experiences associated with level of understanding. Methods: One hundred and sixty-six adult orthopaedic trauma surgery patients across two clinical sites of an academic institution participated in an internet-based survey (2352 invited, 7.1% response rate). Demographic, clinical, and personal experience variables, as well as perceptions surrounding opioid use were collected. Relationships between patient characteristics and opioid perceptions were identified using univariate and multivariable logistic regressions. Alpha = 0.05. Results: Excellent recognition (> 85% correct) of common opioids, side effects, withdrawal symptoms, and disposal methods was demonstrated by 29%, 10%, 30%, and 2.4% of patients; poor recognition (< 55%) by 11%, 56%, 33%, and 52% of patients, respectively. Compared with white patients, non-white patients had 7.8 times greater odds (95% confidence interval [CI] 1.9–31) of perceiving addiction discrepancy (p = 0.004). Employed patients with higher education levels were less likely to have excellent understanding of side effects (adjusted odds ratio [aOR] 0.06, 95% CI 0.006–0.56; p = 0.01) and to understand that dependence can occur within 2 weeks (aOR 0.28, 95% CI 0.09–0.86; p = 0.03) than unemployed patients. Patients in the second least disadvantaged ADI quartile were more knowledgeable about side effects (aOR 8.8, 95% CI 1.7–46) and withdrawal symptoms (aOR 2.7, 95% CI 1.0–7.2; p = 0.046) than those in the least disadvantaged quartile. Patients who knew someone who was dependent or overdosed on opioids were less likely to perceive addiction discrepancy (aOR 0.24, 95% CI 0.07–0.76; p = 0.02) as well as more likely to have excellent knowledge of withdrawal symptoms (aOR 2.6, 95% CI 1.1–6.5, p = 0.03) and to understand that dependence can develop within 2 weeks (aOR 3.8, 95% CI 1.5–9.8, p = 0.005). Conclusions: Level of understanding regarding opioid use is low among orthopaedic trauma surgery patients. Clinical and personal experiences with opioids, in addition to demographics, should be emphasized in the clinical history. [ABSTRACT FROM AUTHOR]

Objective This study aimed to validate a novel, three faced, colour-coded, action-oriented tool: The Stoplight Pain Scale (SPS). Methods A prospective observational cohort study was conducted at a Canadian paediatric emergency department from November 2014 to February 2017. Patients aged 3 to 12 years and their caregivers were asked to rate pain using the SPS and the Faces Pain Scale-Revised (FPS-R). Pain was measured just before analgesia administration, 30 minutes after analgesia administration, and immediately following a painful procedure. Results A total of 227 patients were included; 26.9% (61/227) were 3 to 5 years old while 73.1% (166/227) were 6 to 12 years old. Using Cohen's κ, agreement for SPS and FPS-R was 'fair' for children (0.28 [95% confidence interval {CI} 0.20 to 0.36]) and 'poor' for caregivers (0.14 [95% CI 0.07 to 0.21]), at initial measurement. The SPS had 'fair' agreement between child and caregiver scores, (0.37 [95% CI 0.27 to 0.47]), compared to FPS-R which showed 'poor' agreement (0.20 [95% CI 0.12 to 0.29]). Absolute agreement between child and caregiver SPS scores improved with repeat exposure; 30 minutes after analgesia administration, caregivers and children had fair agreement (κ=0.38, 95% CI 0.28 to 0.48); they had moderate agreement directly following painful procedures (κ=0.46, 95% CI 0.34 to 0.59). Overall, 72.4% (139/192) of children and 60.2% (118/196) of caregivers preferred SPS over FPS-R. Conclusion The SPS demonstrates fair agreement with FPS-R for children and fair-moderate agreement between children and caregivers; agreement improved with repeat use. The SPS is simple and easy to use; it may have a role in empowering direct child and family involvement in pain management. [ABSTRACT FROM AUTHOR]

Background older people coping with the impacts of living with multimorbidity are at increased risk of developing a depressive disorder. Objective this article reports the 24-month results of a randomised controlled trial of an internet-delivered cognitive behaviour therapy, which aimed to test whether depressive disorders could be prevented in this population. Participants community-based participants aged 65 years and over, who had two or more chronic physical health conditions and were assessed as having no current depressive disorder. Methods in total, 302 participants were randomised to an 8-week, five-lesson, internet-delivered intervention program (n  = 150) or treatment as usual (TAU, n  = 152). The primary outcomes were cases of depressive disorder, assessed post-intervention and at 3-month intervals throughout the trial, and depressive symptoms, assessed at pre-intervention, post-intervention, 6, 12 and 24 months following the intervention. Results there were significantly fewer cases of depressive disorder in the intervention group (n  = 23, 15%) compared with the TAU group (n  = 41, 27%) during the 24 months after the intervention (χ2(1, N  = 302) = 6.13, P  = 0.013, odds ratio = 0.490 [95% confidence interval: 0.277, 0.867]), representing a 44% reduction in cases of depressive disorder. No differences were found on depressive symptoms at 24-month follow-up. Internet-delivered cognitive behaviour therapy had high engagement and acceptability. Conclusions the results provide support that depressive disorders can be prevented in older people with multimorbidity through participation in internet-delivered cognitive behaviour therapy. With access to internet-delivered interventions in clinical care settings increasing, this has implications for older patient care where multimorbidity is extremely common. [ABSTRACT FROM AUTHOR]

Background: Although the athleticism required of cheerleaders has increased, the risks of cheerleading have been less studied as compared with other sports. Purpose: To update our understanding of the epidemiology of cheerleading-related injuries. Study Design: Descriptive epidemiology study. Methods: We analyzed the National Electronic Injury Surveillance System (NEISS) for cheerleading-related injuries presenting to nationally representative emergency departments (EDs) in the United States from January 2010 through December 2019. Extracted data included patient age and sex, injury characteristics (diagnosis, body region injured, time of year, and location where injury occurred), and hospital disposition. Using patient narratives, we recorded the cheerleading skills, settings, and mechanisms that led to injury. NEISS sample weights were used to derive national estimates (NEs) from actual case numbers. Results: From 2010 to 2019, a total of 9868 athletes (NE = 350,000; 95% CI, 250,000-450,000) aged 5-25 years presented to US EDs for cheerleading injuries. The annual number of injuries decreased by 15%, from 982 (NE = 35,000; 95% CI, 27,000-44,000) to 897 (NE = 30,000; 95% CI, 18,000-42,000) (P =.048), corresponding to a 27% decline in the injury rate per 100,000 cheerleaders (P <.01). The annual number of injuries caused by performing stunts decreased by 24%, from 240 (NE = 8700; 95% CI, 6700-11,000) to 216 (NE = 6600; 95% CI, 4000-9200) (P =.01), with a 36% decline in the corresponding injury rate per 100,000 cheerleaders (P <.01). Despite these decreases, annual incidence of concussions/closed head injuries increased by 44%, from 128 (NE = 3800; 95% CI, 2900-4700) to 171 (NE = 5500; 95% CI, 3400-7700) (P =.02), and patients requiring hospital admission increased by 118%, from 18 (NE = 330; 95% CI, 250-410) to 24 (NE = 720; 95% CI, 440-1000) (P <.01). The hospital admission rate increased by 9.0% (P =.02). Conclusion: The number of cheerleading-related injuries presenting to US EDs decreased from 2010 to 2019. However, the incidence of concussions/closed head injuries and hospital admissions increased, suggesting that further measures are needed to improve safety for cheerleaders. [ABSTRACT FROM AUTHOR]

Background: In-brace correction and brace compliance with thoraco-lumbo-sacral orthotic (TLSO) braces are associated with successful treatment of adolescent idiopathic scoliosis (AIS). This paper compares patients who had consistent radiographic documentation of in-brace correction to those who did not. Methods: All skeletally immature (Risser 0-2) patients were treated for AIS (25-45°) with full-time TLSO braces that had compliance temperature monitors. All patients wore their braces at least 12 h a day. Brace failure was defined as curve progression to a surgical magnitude (≥ 50°). All patients were followed until brace discontinuation. Results: Ninety patients (F 82, M 8) with an average age of 12.1 (10.1-15.0) years, Risser grade 0 (0-2), BMI percentile 48.5 (0.0-98.8), and daily brace wear of 16.5 (12.1-21.6) h/day were treated for 24.3 (8.0-66.6) months. Patients went through 1.7 (1-4) braces on average. Forty-two out of 90 (46.7%) patients had some amount of brace time with an unknown in-brace correction, which, on average, was 66.1% of their total treatment course (11.5-100). On univariate analysis, patients that did not have a repeat in-brace x-ray with major brace adjustments or new brace fabrication tended to be more skeletally immature (Risser 0 and tri-radiate open, p = 0.028), wear more braces throughout their treatment (2.0 vs 1.4, p < 0.001), were treated for a longer period of time (27 vs 22 months, p = 0.022), and failed bracing more often (47.6% vs 22.9%, p = 0.014). Conclusions: Patients who did not have new in-brace x-rays with major brace adjustments and/or new brace fabrication were 3.1 (95% CI 1.2-7.6) times more likely to fail bracing than patients who were re-checked with new in-brace x-rays. Trial registration: ClinicalTrials.gov—NCT02412137, initial registration date April 2015 Level of evidence: III [ABSTRACT FROM AUTHOR]

Objective This pilot trial examined the effects of a combined intervention of mindfulness meditation followed by aerobic walking exercise compared with a control condition in chronic low back pain patients. We hypothesized that meditation before exercise would reduce disability, pain, and anxiety by increasing mindfulness prior to physical activity compared with an audiobook control group. Participants Thirty-eight adults completed either meditation and exercise treatment (MedExT) (n=18) or an audiobook control condition (n=20). Setting Duquesne University Exercise Physiology Laboratory. Design A pilot, assessor-blinded, randomized controlled trial. Methods Over a 4-week period, participants in the MedExT group performed 12–17 minutes of guided meditation followed by 30 minutes of moderate-intensity walking exercise 5 days per week. Measures of disability, pain, mindfulness, and anxiety were taken at baseline and postintervention. Pain perception measurements were taken daily. Results Compared with the control group, we observed larger improvements in disability in the MedExT intervention, although the changes were modest and not statistically significant (mean between-group difference, –1.24; 95% confidence interval [CI], –3.1 to 0.6). For secondary outcome measures, MedExT increased mindfulness (within-group) from pre-intervention to postintervention (P =0.0141). Additionally, mean ratings of low back pain intensity and unpleasantness significantly improved with time for the MedExT group compared with that of the control group, respectively (intensity P =0.0008; unpleasantness P =0.0022). Conclusion. Overall, 4 weeks of MedExT produced suggestive between-group trends for disability, significant between-group differences for measures of pain, and significant within-group increases in mindfulness. [ABSTRACT FROM AUTHOR]

Background Given the current opioid crisis, caregivers have mounting fears regarding the use of opioid medication in their children. We aimed to determine caregivers' a) willingness to accept, b) reasons for refusing, and c) past experiences with opioids. Methods A novel electronic survey of caregivers of children aged 4 to 16 years who had an acute musculoskeletal injury and presented to two Canadian paediatric emergency departments (ED) (March to November 2017). Primary outcome was caregiver willingness to accept opioids for moderate pain for their children. Results Five hundred and seventeen caregivers participated; mean age was 40.9 (SD 7.1) years with 70.0% (362/517) mothers. Children included 62.2% (321/516) males with a mean age of 10.0 (SD 3.6) years. 49.6% of caregivers (254/512) reported willingness to accept opioids for ongoing moderate pain in the ED, while 37.1% (190/512) were 'unsure'; 33.2% (170/512) of caregivers would accept opioids for at-home use, but 45.5% (233/512) were 'unsure'. Caregivers' primary concerns were side effects, overdose, addiction, and masking of diagnosis. Caregiver fear of addiction (odds ratio [OR] 1.12, 95% confidence interval [CI] 1.01 to 1.25) and side effects (OR 1.25, 95% CI 1.11 to 1.42) affected willingness to accept opioids in the emergency department ; fears of addiction (OR 1.19, 95% CI 1.07 to 1.32), and overdose (OR 1.15, 95% CI 1.04 to 1.27) affected willingness to accept opioids for at-home use. Conclusions Only half of the caregivers would accept opioids for moderate pain, despite ongoing pain following nonopioid analgesics. Caregivers' fears of addiction, side effects, overdose, and masking diagnosis may have influenced their responses. These findings are a first step in understanding caregiver analgesic decision making. [ABSTRACT FROM AUTHOR]

Objective To measure the variability in discharge opioid prescription practices for children discharged from the emergency department (ED) with a long-bone fracture. Design A retrospective cohort study of pediatric ED visits in 2015. Setting Four pediatric EDs. Subjects Children aged four to 18 years with a long-bone fracture discharged from the ED. Methods A multisite registry of electronic health record data (PECARN Registry) was analyzed to determine the proportion of children receiving an opioid prescription on ED discharge. Multivariable logistic regression was performed to determine characteristics associated with receipt of an opioid prescription. Results There were 5,916 visits with long-bone fractures; 79% involved the upper extremity, and 27% required reduction. Overall, 15% of children were prescribed an opioid at discharge, with variation between the four EDs: A = 8.2% (95% confidence interval [CI] = 6.9–9.7%), B = 12.1% (95% CI = 10.5–14.0%), C = 16.9% (95% CI = 15.2–18.8%), D = 23.8% (95% CI = 21.7–26.1%). Oxycodone was the most frequently prescribed opioid. In the regression analysis, in addition to variation by ED site of care, age 12–18 years, white non-Hispanic, private insurance status, reduced fracture, and severe pain documented during the ED visit were associated with increased opioid prescribing. Conclusions For children with a long-bone fracture, discharge opioid prescription varied widely by ED site of care. In addition, black patients, Hispanic patients, and patients with government insurance were less likely to be prescribed opioids. This variability in opioid prescribing was not accounted for by patient- or injury-related factors that are associated with increased pain. Therefore, opioid prescribing may be modifiable, but evidence to support improved outcomes with specific treatment regimens is lacking. [ABSTRACT FROM AUTHOR]

Reproductive events, such as ovulation, trigger an inflammatory cascade. Few studies have examined their long-term influence on inflammatory profiles. We included 3,393 premenopausal and 3,915 postmenopausal women with intact ovaries/uterus from the Nurses' Health studies (Nurses' Health Study (1989–1990) and Nurses' Health Study II (1996–1999)) in an analysis of the association between lifetime ovulatory years (LOY) and levels of inflammatory biomarkers. We estimated LOY as age at menopause (age at blood collection for premenopausal women) minus age at menarche, subtracting years of oral contraceptive (OC) use and 1 year per pregnancy. After adjustment for other inflammation-related factors (e.g. body mass index, exercise, diet), every 5-year increase in LOY was associated with lower C-reactive protein (CRP) levels in both premenopausal (difference = −11.5%, 95% confidence interval: −15.0, −8.0; P  < 0.0001) and postmenopausal (difference = −7.2%, 95% confidence interval: −10.0, −4.3; P  < 0.0001) women. Older age at menopause (P  = 0.007), earlier menarche (P  = 0.007), and shorter duration of OC use (P  = 0.002) were associated with lower CRP levels in postmenopausal women, whereas duration of OC use was positively associated with CRP levels in premenopausal women (P  < 0.0001). LOY was modestly inversely associated with interleukin 6 in postmenopausal women (P  = 0.03). Notably, the associations of CRP with LOY were similar in magnitude to associations with exercise and a healthy diet, though weaker than the association with body mass index. Although many reproductive events induce acute inflammation, increased LOY was associated with lower chronic systemic inflammation even after menopause. [ABSTRACT FROM AUTHOR]

BACKGROUND: Aedes aegypti and Ae. albopictus are mosquito vectors of more than 22 arboviruses that infect humans. OBJECTIVES: Our objective was to develop regional ecological niche models for Ae. aegypti and Ae. albopictus in the conterminous United States and Canada with current observed and simulated climate and land-use data using boosted regression trees (BRTs). METHODS: We used BRTs to assess climatic suitability for Ae. albopictus and Ae. aegypti mosquitoes in Canada and the United States under current and future projected climates. RESULTS: Models for both species were mostly influenced by minimum daily temperature and demonstrated high accuracy for predicting their geographic ranges under the current climate. The northward range expansion of suitable niches for both species was projected under future climate models. Much of the United States and parts of southern Canada are projected to be suitable for both species by 2100, with Ae. albopictus projected to expand its range north earlier this century and further north than Ae. aegypti. DISCUSSION: Our projections suggest that the suitable ecological niche for Aedes will expand with climate change in Canada and the United States, thus increasing the risk of Aedes-transmitted arboviruses. Increased surveillance for these vectors and the pathogens they carry would be prudent. [ABSTRACT FROM AUTHOR]

BACKGROUND: Endocrine-disrupting chemicals have been shown to have broad effects on development, but their mutagenic actions that can lead to cancer have been less clearly demonstrated. Physiological levels of estrogen have been shown to stimulate DNA damage in breast epithelial cells through mechanisms mediated by estrogen-receptor alpha (ERa). Benzophenone-3 (BP-3) and propylparaben (PP) are xenoestrogens found in the urine of >96% of U.S. population. OBJECTIVES: We investigated the effect of BP-3 and PP on estrogen receptor–dependent transactivation and DNA damage at concentrations relevant to exposures in humans. METHODS: In human breast epithelial cells, DNA damage following treatment with 17β-estradiol (E[sub 2]), BP-3, and PP was determined by immunostaining with antibodies against γ-H2AX and 53BP1. Estrogenic responses were determined using luciferase reporter assays and gene expression. Formation of R-loops was determined with DNA: RNA hybrid-specific S9.6 antibody. Short-term exposure to the chemicals was also studied in ovariectomized mice. Immunostaining of mouse mammary epithelium was performed to quantify R-loops and DNA damage in vivo. RESULTS: Concentrations of 1µM and 5µM BP-3 or PP increased DNA damage similar to that of E2 treatment in a ERα-dependent manner. However, BP-3 and PP had limited transactivation of target genes at 1µM and 5µM concentrations. BP-3 and PP exposure caused R-loop formation in a normal human breast epithelial cell line when ERa was introduced. R-loops and DNA damage were also detected in mammary epithelial cells of mice treated with BP-3 and PP. CONCLUSIONS: Acute exposure to xenoestrogens (PP and BP-3) in mice induce DNA damage mediated by formation of ERα-dependent R-loops at concentrations 10-fold lower than those required for transactivation. Exposure to these xenoestrogens may cause deleterious estrogenic responses, such as DNA damage, in susceptible individuals. [ABSTRACT FROM AUTHOR]

Objectives: Publicity on incidents of electronic nicotine delivery systems (ENDS) exploding or catching fire may influence smokers' risk perceptions and decisions about using ENDS for quitting smoking. We examined combustible cigarette smokers' perceptions of the possibility of injury from exploding ENDS and the relationship of those perceptions to ENDS use, perceived risk relative to smoking, and perceived costs and benefits of ENDS use. Methods: We used data from the 2017 Tobacco Products and Risk Perceptions Survey of a national probability sample of US adults, conducted online in August and September 2017. The analytic sample consisted of 1181 current combustible cigarette smokers aware of ENDS. Results: Among combustible cigarette smokers aware of ENDS, a medium/high perceived risk of injury from exploding ENDS was associated with lower odds of current ENDS use (adjusted odds ratio [aOR] = 0.50; 95% confidence interval [CI], 0.30-0.86; P =.01), perceiving ENDS to be at least as harmful as cigarettes (aOR = 3.22; 95% CI, 2.11-4.93; P <.001), and feeling that the negatives of ENDS use outweighed the positives (aOR = 3.50; 95% CI, 2.00-6.14; P <.001). Conclusions: Product standards, improved product labeling, and education about how to properly use, charge, and store ENDS can help protect consumers from injury. Communication efforts should seek to fully inform combustible cigarette smokers about both the absolute health risks of ENDS, including risk of explosions, and their relative risks compared with those of cigarette smoking. [ABSTRACT FROM AUTHOR]

Objective: To evaluate costs and consequences of a new back pain service provided by chiropractors integrated into a Community Health Centre in Cambridge, Ontario. The study sample included 95 consecutive patients presenting between January 2014 to January 2016 with a mixture of sub-acute and chronic back pain. Methods: A secondary cost-utility analysis was performed and conducted from the perspective of the healthcare institution. Cost-utility was calculated as cost per quality-adjusted life year (QALY) gained over a time horizon of 90 days. Results: According to the EuroQol 5 Domain questionnaire, nearly 70% of patients improved. The mean number of treatment sessions was 8.4, and an average of 0.21 QALYs were gained at an average cost per QALY of $1,042. Seventy-seven percent of patients did not visit their primary care provider over the 90- day period, representing potential cost savings to the institution of between $2,022.23 and $6,135.82. Conclusion: Adding chiropractic care to usual medical care was associated with improved outcomes at a reasonable cost in a sample of complex patients with sub-acute and chronic back pain. Future comparative cost-effectiveness studies are needed. [ABSTRACT FROM AUTHOR]

Context: Knowledge of the bilateral difference in humeral torsion (HT) enables clinicians to implement appropriate interventions for soft tissue restrictions of the shoulder to restore rotational motion and reduce injury risk. Whereas the current ultrasound method for measuring HT requires 2 assessors, a more efficient 1-person technique (1PT) may be of value. Objective: To determine if a 1PT is a reliable and valid alternative to the established 2-person technique (2PT) for indirectly measuring HT using ultrasound. Design: Descriptive laboratory study. Setting: Biomechanics laboratory. Patients or Other Participants: A convenience sample of 16 volunteers (7 men, 9 women; age = 26.9 ± 6.8 years, height = 172.2 ± 10.7 cm, mass = 80.0 ± 13.3 kg). Main Outcome Measure(s): We collected the HT data using both the 1PT and 2PT from a total of 30 upper extremities (16 left, 14 right). Within-session intrarater reliability (intraclass correlation coefficient; ICC [3,1]) and standard error of measurement (SEM) were assessed for both techniques. Simple linear regression and Bland-Altman analysis were used to examine the validity of the 1PT when compared with the established 2PT. Results: The 1PT (ICC [3,1] = 0.992, SEM = 0.8°) and 2PT (ICC [3,1] = 0.979, SEM = 1.1°) demonstrated excellent within-session intrarater reliability. A strong linear relationship was demonstrated between the HT measurements collected with both techniques (r = 0.963, r2 = 0.928, F1,28 = 361.753, P < .001). A bias of -1.28 ± 2.68 was revealed, and the 95% limits of agreement indicated the 2 techniques can be expected to vary from -6.3° to 3.8°. Conclusions: The 1PT for measuring HT using ultrasound was a reliable and valid alternative to the 2PT. By reducing the number of testers involved, the 1PT may provide clinicians with a more efficient and practical means of obtaining these valuable clinical data. [ABSTRACT FROM AUTHOR]

Abstract: Objective: The purpose of this study was to determine the proportion of children undergoing procedural sedation for fracture reduction in the emergency department (ED) observed to experience negative postdischarge behaviors. Predictors of negative behaviors were evaluated, including anxiety. Methods: This was a prospective cohort study of children receiving intravenous ketamine sedation for ED fracture reduction. The child's anxiety prior to sedation was measured with the Modified Yale Preoperative Anxiety Scale. Negative behavioral changes were measured with the Post‐Hospitalization Behavior Questionnaire 1 to 2 weeks after discharge. Descriptive statistics and odds ratios (ORs) were calculated. Chi‐square test was used for comparisons between groups. Multivariable logistic regression models evaluated predictors of negative behavioral change after discharge. Results: Ninety‐seven patients were enrolled; 82 (85%) completed follow‐up. Overall, 33 (40%) children were observed to be highly anxious presedation and 18 (22%) had significant negative behavior changes after ED discharge. Independent predictors for negative behaviors were high anxiety (OR = 9.0, 95% confidence interval [CI] = 2.3–35.7) and nonwhite race (OR = 6.5, 95% CI = 1.7–25.0). Conclusion: For children undergoing procedural sedation in the ED, two in five children have high preprocedure anxiety and almost one in four have significant negative behaviors 1 to 2 weeks after discharge. Highly anxious and nonwhite children have increased risk of negative behavioral changes that have not been previously recognized in the ED setting. [ABSTRACT FROM AUTHOR]

Background: Weight loss in individuals at high risk of diabetes is an effective prevention method and a major component of the currently prevailing diabetes prevention strategies. The aim of the present study was to investigate the public health potential for diabetes prevention of weight maintenance or moderate weight loss on a population level in an observational cohort with repeated measurements of weight and diabetes status.Methods: Height, weight and diabetes status were objectively measured at baseline and 10 year follow-up in a population-based cohort of 33,184 participants aged 30-60 years between 1990 and 2013 in Västerbotten County, Sweden. The association between risk of incident diabetes and change in BMI or relative weight was modelled using multivariate logistic regression. Population attributable fractions (PAF) were used to assess population impact of shift in weight.Results: Mean (SD) BMI at baseline was 25.0 (3.6) kg/m2. Increase in relative weight between baseline and follow-up was linearly associated with incident diabetes risk, odds ratio (OR) 1.05 (95% confidence interval (CI) 1.04-1.06) per 1% change in weight. Compared to weight maintenance (±1.0 kg/m2), weight gain of > +1.0 kg/m2 was associated with an increased risk of incident diabetes, OR 1.52 (95% CI 1.32, 1.74), representing a PAF of 21.9% (95% CI 15.8, 27.6%). For moderate weight loss (-1.0 to -2.0 kg/m2) the OR was 0.72 (95% CI 0.52, 0.99).Conclusions: Weight maintenance in adulthood is strongly associated with reduced incident diabetes risk and there is considerable potential for diabetes prevention in promoting this as a whole population strategy. [ABSTRACT FROM AUTHOR]

Background: The mechanism and clinical significance of low circulating 25-hydroxyvitamin D [25(OH)D] in obese people are unknown. Low total 25(OH)D may be due to low vitamin D-binding proteins (DBPs) or faster metabolic clearance. However, obese people have a higher bone mineral density (BMD), which suggests that low 25(OH)D may not be associated with adverse consequences for bone. Objective: We sought to determine whether 1) vitamin D metabolism and 2) its association with bone health differ by body weight. Design: We conducted a cross-sectional observational study of 223 normal-weight, overweight, and obese men and women aged 25-75 y in South Yorkshire, United Kingdom, in the fall and spring. A subgroup of 106 subjects was also assessed in the winter. We used novel techniques, including an immunoassay for free 25(OH)D, a stable isotope for the 25(OH)D3 half-life, and high-resolution quantitative tomography, to make a detailed assessment of vitamin D physiology and bone health. Results: Serum total 25(OH)D was lower in obese and overweight subjects than in normal-weight subjects in the fall and spring (geometric means: 45.0 and 40.8 compared with 58.6 nmol/L, respectively; P < 0.001) but not in the winter. Serum 25(OH)D was inversely correlated with body mass index (BMI) in the fall and spring and in the winter. Free 25(OH)D and 1,25-dihydroxyvitamin D [1,25(OH)2D] were lower in obese subjects. DBP, the DBP genotype, and the 25(OH)D3 half-life did not differ between BMI groups. Bone turnover was lower, and bone density was higher, in obese people. Conclusions: Total and free 25(OH)D and 1,25(OH)2D are lower at higher BMI, which cannot be explained by lower DBP or the shorter half-life of 25(OH)D3. We speculate that low 25(OH)D in obesity is due to a greater pool of distribution. Lower 25(OH)D may not reflect at-risk skeletal health in obese people, and BMI should be considered when interpreting serum 25(OH)D as a marker of vitamin D status. [ABSTRACT FROM AUTHOR]

Background. Breast cancer brain metastasis (BCBM) confers a poor prognosis and is unusual in requiring multidisciplinary care in the metastatic setting. The University of North Carolina at Chapel Hill (UNC-CH) has created a BCBM clinic to provide medical and radiation oncology, neurosurgical, and supportive services to this complex patient population. We describe organization and design of the clinic as well as characteristics, treatments, and outcomes of the patients seen in its first 3 years. Methods. Clinical and demographic data were collected from patients in a prospectively maintained database. Descriptive statistics are reported as percentages and means. The Kaplan-Meier method was used to estimate time-to-event outcomes. Results. Sixty-five patients were seen between January 2012 and January 2015. At the time of presentation to the BCBM clinic, most patients (74%) had multiple (≥2) brain metastases and had received prior systemic (77%) and whole-brain radiation therapy and/or central nervous system stereotactic radiosurgery (65%) in the metastatic setting. Seventy-eight percent returned for a follow-up visit; 32% were enrolled in a clinical trial. Median time from diagnosis of brain metastasis to death was 2.11 years (95% confidence interval [CI] 1.31-2.47) for all patients, 1.15 years (95% CI 0.4-2.43) for triple-negative breast cancer, 1.31 years (95% CI 0.51-2.52) for hormone receptor-positive/HER22 breast cancer, and 3.03 years (95% CI lower limit 1.94, upper limit not estimable) for HER21 breast cancer (p = .0037). Conclusion. Patients with BCBM have unique and complex needs that require input from several oncologic disciplines. The development of the UNC-CH multidisciplinary BCBM clinic is a model that can be adapted at other centers to provide coordinated care for patients with a challenging and complex disease. [ABSTRACT FROM AUTHOR]

Objective: In this study, health event capture is broadly defined as the degree to which a group of people use a particular provider network as their primary source of health care services. The Marshfield Epidemiologic Study Area (MESA) is a valuable resource for population-based health research, but the completeness of health event capture has not been validated in recent years. Our objective was to determine the current level of outpatient and inpatient health event capture by Marshfield Clinic (MC) facilities and affiliated hospitals for people living within MESA. Design: A stratified sample survey with strata defined by MESA region (Central or North) and age group (< 18 years or a 18 years). Setting: 24 ZIP codes in central and northern Wisconsin, USA. Participants: 2,485 individuals participated of the 4,313 sampled cohort members residing in MESA Central (N=61,041) and MESA North (N=25,906) on February 22, 2011. Methods: A health care utilization survey was mailed to a random sample stratified by age group and MESA region. Telephone interviews were attempted for nonrespondents. The survey requested information on sources of outpatient care and overnight hospital admissions. Population proportions representing health event capture metrics and corresponding 95% confidence intervals (CI) were estimated with analytic weights applied to account for the survey design. Results: Among those with an outpatient visit during the past 24 months, the most recent visit of an estimated 93% (95% CI, 91 % - 94%) was at a MC facility. The most recent admission of an estimated 93% (95% CI, 90% - 96%) of those hospitalized in the past 24 months was at a hospital affiliated with MC. The proportion admitted to MC affiliated hospitals was higher for residents of MESA Central (97%) compared to MESA North (83%). Conclusion: A high proportion of outpatient visits and inpatient admissions in MESA Central and MESA North are accessible in the MC electronic health record. This pattern of high health event capture has been demonstrated since the inception of MESA in 1991. The results from this study validate and support the continued use of MESA for population-based epidemiologic and clinical research. [ABSTRACT FROM AUTHOR]

Against the backdrop of late 20th century declines in heart disease mortality in the United States, race-specific rates diverged because of slower declines among blacks compared with whites. To characterize the temporal dynamics of emerging black-white racial disparities in heart disease mortality, we decomposed race-sex-specific trends in an age-period-cohort (APC) analysis of US mortality data for all diseases of the heart among adults aged ≥35 years from 1973 to 2010. The black-white gap was largest among adults aged 35-59 years (rate ratios ranged from 1.2 to 2.7 for men and from 2.3 to 4.0 for women) and widened with successive birth cohorts, particularly for men. APC model estimates suggested strong independent trends across generations ("cohort effects") but only modest period changes. Among men, cohort-specific black-white racial differences emerged in the 1920-1960 birth cohorts. The apparent strength of the cohort trends raises questions about life-course inequalities in the social and health environments experienced by blacks and whites which could have affected their biomedical and behavioral risk factors for heart disease. The APC results suggest that the genesis of racial disparities is neither static nor restricted to a single time scale such as age or period, and they support the importance of equity in life-course exposures for reducing racial disparities in heart disease. [ABSTRACT FROM AUTHOR]

Background: Swaps are often used to encourage healthier food choices, but there is little evidence of their effectiveness. The current study assessed the impact of offering swaps on groceries purchased within a bespoke online supermarket; specifically the objective was to measure the impact on energy density (ED) of food purchases following the offer of lower ED alternatives (a) at point of selection or at checkout, and (b) with or without explicit consent to receive swap prompts. Method: Participants were asked to complete a 12-item shopping task within an online shopping platform, developed for studying food purchasing. 1610 adults were randomly assigned to a no swap control condition or to one of four interventions: consented swaps at selection; consented swaps at checkout; imposed swaps at selection; or imposed swaps at checkout. Each swap presented two lower ED options from the same category as the participant's chosen food. Swap acceptance rate and purchased food ED were the primary outcomes. Results: Of the mean 12.36 (SD 1.26) foods purchased, intervention participants were offered a mean of 4.1 (SD 1.68) swaps, with the potential to reduce the ED of purchased food (effect (95 % CI): -83 kJ/100 g (-110 - -56), p = <0.0001). A median of one swap (IQR 0 to 2) was accepted, not significantly reducing the purchased food ED (effect (95 % CI): -24 kJ/100 g (4 - -52), p = 0.094). More swaps were accepted when offered at selection than at checkout (OR (95 % CI) = 1.224 (1.11 - 1.35), p< 0.0001), but no differences were seen with consent. Purchased food ED was unaffected by point of swap or consent, but reduced with number of swaps accepted (effect per swap (95 % CI) = -24 kJ/100g (-35 --14), p< 0.0001). Conclusion: Within category swaps did not reduce the ED of food purchases reflecting the observation that the use of swaps within an on-line shopping platform offered small potential gains in ED and a minority was accepted. [ABSTRACT FROM AUTHOR]

Background: Limited data are available on the accuracy of 24-h dietary recalls used to monitor US sodium and potassium intakes. Objective: We examined the difference in usual sodium and potassium intakes estimated from 24-h dietary recalls and urine collections. Design: We used data from a cross-sectional study in 402 participants aged 18-39 y (w50% African American) in the Washington, DC, metropolitan area in 2011. We estimated means and percentiles of usual intakes of daily dietary sodium (dNa) and potassium (dK) and 24-h urine excretion of sodium (uNa) and potassium (uK). We examined Spearman's correlations and differences between estimates from dietary and urine measures. Multiple linear regressions were used to evaluate the factors associated with the difference between dietary and urine measures. Results: Mean differences between diet and urine estimates were higher in men [dNa - uNa (95% CI) = 936.8 (787.1, 1086.5) mg/d and dK - uK = 571.3 (448.3, 694.3) mg/d] than in women [dNa - uNa (95% CI) = 108.3 (11.1, 205.4) mg/d and dK - uK = 163.4 (85.3, 241.5 mg/d)]. Percentile distributions of diet and urine estimates for sodium and potassium differed for men. Spearman's correlations between measures were 0.16 for men and 0.25 for women for sodium and 0.39 for men and 0.29 for women for potassium. Urinary creatinine, total caloric intake, and percentages of nutrient intake from mixed dishes were independently and consistently associated with the differences between diet and urine estimates of sodium and potassium intake. For men, body mass index was also associated. Race was associated with differences in estimates of potassium intake. Conclusions: Low correlations and differences between dietary and urinary sodium or potassium may be due to measurement error in one or both estimates. Future analyses using these methods to assess sodium and potassium intake in relation to health outcomes may consider stratifying by factors associated with the differences in estimates from these methods. This trial was registered at clinicaltrials.gov as NCT01631240. [ABSTRACT FROM AUTHOR]

Adverse social environments in early life are hypothesized to become biologically embedded during the first few years of life, with potentially far-reaching implications for health across the life course. Using prospective data from a subset of a US birth cohort, the Collaborative Perinatal Project, started in 1959–1966 (n = 566), we examined associations of social disadvantage assessed in childhood with cardiometabolic function and chronic disease status more than 40 years later (in 2005–2007). Social disadvantage was measured with an index that combined information on adverse socioeconomic and family stability factors experienced between birth and age 7 years. Cardiometabolic risk (CMR) was assessed by combining information from 8 CMR biomarkers; an index of chronic disease status was derived by assessing 8 chronic diseases. Poisson models were used to investigate associations between social disadvantage and CMR or chronic disease scores while adjusting for childhood covariates and potential pathway variables. A high level of social disadvantage was significantly associated with both higher CMR (incident rate ratio = 1.69, 95% confidence interval: 1.19, 2.39) and with a higher number of chronic diseases (incident rate ratio = 1.39, 95% confidence interval: 1.00, 1.92) in minimally adjusted models. Associations with CMR persisted even after accounting for childhood and adult covariates. [ABSTRACT FROM PUBLISHER]

Background In an evaluation of a new health technology, a pilot trial may be undertaken prior to a trial that makes a definitive assessment of benefit. The objective of pilot studies is to provide sufficient evidence that a larger definitive trial can be undertaken and, at times, to provide a preliminary assessment of benefit. Methods We describe significance thresholds, confidence intervals and surrogate markers in the context of pilot studies and how Bayesian methods can be used in pilot trials. We use a worked example to illustrate the issues raised. Results We show how significance levels other than the traditional 5% should be considered to provide preliminary evidence for efficacy and how estimation and confidence intervals should be the focus to provide an estimated range of possible treatment effects. We also illustrate how Bayesian methods could also assist in the early assessment of a health technology. Conclusions We recommend that in pilot trials the focus should be on descriptive statistics and estimation, using confidence intervals, rather than formal hypothesis testing and that confidence intervals other than 95% confidence intervals, such as 85% or 75%, be used for the estimation. The confidence interval should then be interpreted with regards to the minimum clinically important difference. We also recommend that Bayesian methods be used to assist in the interpretation of pilot trials. Surrogate endpoints can also be used in pilot trials but they must reliably predict the overall effect on the clinical outcome. [ABSTRACT FROM AUTHOR]