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We assessed fidelity of delivery and participant engagement in the implementation of a community paramedic coach-led Care Transitions Intervention (CTI) program adapted for use following emergency department (ED) visits. The adapted CTI for ED-to-home transitions was implemented at three university-affiliated hospitals in two cities from 2016 to 2019. Participants were aged ≥60 years old and discharged from the ED within 24 hours of arrival. In the current analysis, participants had to have received the CTI. Community paramedic coaches collected data on program delivery and participant characteristics at each transition contact via inventories and assessments. Participants provided commentary on the acceptability of the adapted CTI. Using a multimethod approach, the CTI implementation was assessed quantitatively for site- and coach-level differences. Qualitatively, barriers to implementation and participant satisfaction with the CTI were thematically analyzed. Of the 863 patient participants, 726 (84.1%) completed their home visits. Cancellations were usually patient-generated (94.9%). Most planned follow-up visits were successfully completed (94.6%). Content on the planning for red flags and post-discharge goal setting was discussed with high rates of fidelity overall (95% and greater), while content on outpatient follow-up was lower overall (75%). Differences in service delivery between the two sites existed for the in-person visit and the first phone follow-up, but the differences narrowed as the study progressed. Participants showed a 24.6% increase in patient activation (i.e., behavioral adoption) over the 30-day study period (p < 0.001). Overall, participants reported that the program was beneficial for managing their health, the quality of coaching was high, and that the program should continue. Not all participants felt that they needed the program. Community paramedic coaches reported barriers to CTI delivery due to patient medical problems and difficulties with phone visit coordination. Coaches also noted refusal to communicate or engage with the intervention as an implementation barrier. Community paramedic coaches delivered the adapted CTI with high fidelity across geographically distant sites and successfully facilitated participant engagement, highlighting community paramedics as an effective resource for implementing such patient-centered interventions. [ABSTRACT FROM AUTHOR]

Background: A greater understanding of the mechanisms of action of weight-management interventions is needed to inform the design of effective interventions.Purpose: To investigate whether dietary restraint, habit strength, or diet self-regulation mediated the impact of a behavioral weight-management intervention on weight loss and weight loss maintenance.Methods: Latent growth curve analysis (LGCA) was conducted on trial data in which adults (N = 1,267) with a body mass index (BMI) ≥28 kg/m2 were randomized to either a brief intervention (booklet on losing weight), a 12 week weight-management program or the same program for 52 weeks. LGCA estimated the trajectory of the variables over four time points (baseline and 3, 12 and 24 months) to assess whether potential mechanisms of action mediated the impact of the weight-management program on BMI.Results: Participants randomized to the 12 and 52 week programs had a significantly greater decrease in BMI than the brief intervention. This direct effect became nonsignificant when dietary restraint, habit strength, and autonomous diet self-regulation were controlled for. The total indirect effect was significant for both the 12 (estimate = -1.33, standard error [SE] = 0.41, p = .001) and 52 week (estimate = -2.13, SE = 0.52, p < .001) program. Only the individual indirect effect for dietary restraint was significant for the 12 week intervention, whereas all three indirect effects were significant for the 52 week intervention.Conclusions: Behavior change techniques that target dietary restraint, habit strength, and autonomous diet self-regulation should be considered when designing weight loss and weight loss maintenance interventions. Longer interventions may need to target both deliberative and automatic control processes to support successful weight management. [ABSTRACT FROM AUTHOR]

The second year of life is a period of nutritional vulnerability. We aimed to investigate the dietary patterns and nutrient intakes from 1 to 2 years of age during the 12-month follow-up period of the Growing Up Milk – Lite (GUMLi) trial. The GUMLi trial was a multi-centre, double-blinded, randomised controlled trial of 160 healthy 1-year-old children in Auckland, New Zealand and Brisbane, Australia. Dietary intakes were collected at baseline, 3, 6, 9 and 12 months post-randomisation, using a validated FFQ. Dietary patterns were identified using principal component analysis of the frequency of food item consumption per d. The effect of the intervention on dietary patterns and intake of eleven nutrients over the duration of the trial were investigated using random effects mixed models. A total of three dietary patterns were identified at baseline: 'junk/snack foods', 'healthy/guideline foods' and 'breast milk/formula'. A significant group difference was observed in 'breast milk/formula' dietary pattern z scores at 12 months post-randomisation, where those in the GUMLi group loaded more positively on this pattern, suggesting more frequent consumption of breast milk. No difference was seen in the other two dietary patterns. Significant intervention effects were seen on nutrient intake between the GUMLi (intervention) and cows' milk (control) groups, with lower protein and vitamin B12, and higher Fe, vitamin D, vitamin C and Zn intake in the GUMLi (intervention) group. The consumption of GUMLi did not affect dietary patterns, however, GUMLi participants had lower protein intake and higher Fe, vitamins D and C and Zn intake at 2 years of age. [ABSTRACT FROM AUTHOR]

Background: Iron deficiency (ID) and vitamin D deficiency (VDD) are significant pediatric health issues in New Zealand and Australia and remain prevalent micronutrient deficiencies in young children globally.Objective: We aimed to investigate the effect of a micronutrient-fortified, reduced-energy growing-up milk (GUMLi) compared with cow milk (CM) consumed for 1 y on dietary iron and vitamin D intakes and the status of New Zealand and Australian children at 2 y of age.Methods: The GUMLi Trial was a multicenter, double-blind, randomized controlled trial in 160 healthy 1-y-old New Zealand and Australian children conducted in 2015-2017. Participants were randomly assigned 1:1 to receive GUMLi (1.7 mg Fe/100 mL; 1.3 µg cholecalciferol/100 mL) or CM (0.02 mg Fe/100 mL; 0.06 µg cholecalciferol/100 mL) for 12 mo. Secondary outcomes, reported here, included change in dietary iron and vitamin D intakes, iron status, and 25-hydroxyvitamin D [25(OH)D] concentrations from blood samples at age 2 y. All regression models were adjusted for baseline outcome and study center.Results: GUMLi was a large contributor to dietary intakes of iron and vitamin D after 12 mo when compared with intakes from food and CM. The adjusted mean difference between groups for serum ferritin concentrations was 17.8 µg/L (95% CI: 13.6, 22.0 µg/L; P < 0.0001), and for 25(OH)D it was 16.6 nmol/L (95% CI: 9.9, 23.3 nmol/L; P < 0.0001). After 12 mo, ID was present in 16 (24%) participants in the CM group and 5 (7%) participants in the GUMLi group (P = 0.009), and the prevalence of VDD in the CM group increased to 14% (n = 10) and decreased to 3% (n = 2) (P = 0.03) in the GUMLi group.Conclusion: In comparison with CM, GUMLi significantly improved dietary iron and vitamin D intakes and the iron and vitamin D status of healthy children at 2 y of age. This trial was registered with the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au) as ACTRN12614000918628. [ABSTRACT FROM AUTHOR]

Objective: To determine if exclusive breast-feeding counselling modifies the association of experience of any lifetime or specific forms of domestic violence (DV) on duration of exclusive breast-feeding (EBF).Design: In the MINIMat trial pregnant women were randomized to receive either usual health messages (UHM) or usual health messages with breast-feeding counselling (BFC) in eight visits. During pregnancy (30 weeks), lifetime experience of any or specific forms of DV was measured. Infant feeding practice information was collected from 0 to 6 months at 15 d intervals.Setting: Matlab, Bangladesh.Subjects: Pregnant and postpartum women (n 3186) and their infants.Results: Among women in the UHM group, those who had experienced any lifetime DV exclusively breast-fed for a shorter duration than women who did not experience any lifetime DV (P=0·02). There was no difference, however, in duration of EBF among women in the BFC group based on their experience of any lifetime DV exposure (P=0·48). Using Cox regression analysis, there was an interaction of exposure to any lifetime DV, sexual violence and controlling behaviour, and counselling group with duration of breast-feeding at or before 6 months (P-interaction≤0·08). Among the UHM group, experience of any lifetime DV, sexual violence or controlling behaviour was associated with fewer days of EBF (P<0·05). In contrast, among the BFC group, experience of DV was not associated with duration of EBF.Conclusions: The experience of DV compromises EBF and the support of breast-feeding counselling programmes could assist this vulnerable group towards better infant feeding practices. [ABSTRACT FROM AUTHOR]

Background: Oral morphine for postoperative pain after minor pediatric surgery, while increasingly popular, is not supported by evidence. We evaluated whether oral morphine was superior to ibuprofen for at-home management of children's postoperative pain.Methods: We conducted a randomized superiority trial comparing oral morphine (0.5 mg/kg) with ibuprofen (10 mg/kg) in children 5 to 17 years of age who had undergone minor outpatient orthopedic surgery (June 2013 to September 2016). Participants took up to 8 doses of the intervention drug every 6 hours as needed for pain at home. The primary outcome was pain, according to the Faces Pain Scale - Revised, for the first dose. Secondary outcomes included additional analgesic requirements, adverse effects, unplanned health care visits and pain scores for doses 2 to 8.Results: We analyzed data for 77 participants in each of the morphine and ibuprofen groups. Both interventions decreased pain scores with no difference in efficacy. The median difference in pain score before and after the first dose of medication was 1 (interquartile range 0-1) for both morphine and ibuprofen (p = 0.2). For doses 2 to 8, the median differences in pain score before and after the dose were not significantly different between groups. Significantly more participants taking morphine reported adverse effects (45/65 [69%] v. 26/67 [39%], p < 0.001), most commonly drowsiness (31/65 [48%] v. 15/67 [22%] in the morphine and ibuprofen groups, respectively; p = 0.003).Interpretation: Morphine was not superior to ibuprofen, and both drugs decreased pain with no apparent difference in efficacy. Morphine was associated with significantly more adverse effects, which suggests that ibuprofen is a better first-line option after minor surgery.Trial Registration: ClinicalTrials.gov, no. NCT01686802. [ABSTRACT FROM AUTHOR]

Objective: This community-based randomized controlled trial was carried out to test the Ending Self-Stigma (ESS) psychoeducational intervention, which is designed to help adults with serious mental illnesses reduce internalization of mental illness stigma and its effects.Methods: A total of 268 adults from five different mental health programs in Maryland took part. After baseline interview, consenting participants were randomly assigned to the nine-week ESS intervention or a minimally enhanced treatment-as-usual control condition. Participants were assessed by using symptom, psychosocial functioning, and self-stigma measures at baseline, postintervention, and six-month follow-up. Demographic characteristics were assessed at baseline.Results: Compared with participants in the control condition, ESS group participants showed significant decreases on the stereotype agreement and self-concurrence subscales of the Self Stigma of Mental Illness Scale, significant improvement on the alienation and stigma resistance subscales of the Internalized Stigma Mental Illness measure, and a significant increase in recovery orientation from baseline to postintervention. None of these differences were sustained at six-month follow-up.Conclusions: Results indicate that ESS was useful in helping to reduce key aspects of internalized stigma among individuals with mental illnesses and that advances in the delivery, targeting, and content of the intervention in the field may be warranted to increase its potency. [ABSTRACT FROM AUTHOR]

Background and Objectives: The prevalence of ADHD is greater in substance use disorders than the general population, and ADHD and substance use disorders share neurobiological features such as dysregulation of reward circuitry. We tested the hypothesis that stimulants would decrease marijuana use in a randomized controlled trial of extended release mixed amphetamine salts (MAS-XR) for treatment of co-occurring ADHD and cocaine use disorders.Methods: Marijuana users were defined as participants reporting use in the 30 days before study initiation, collected with timeline follow-back. The original 14-week trial utilized a 3-arm randomized design, comparing placebo, MAS-XR 60 mg, and MAS-XR 80 mg. For this analysis, both MAS-XR groups were combined, leaving n = 20 in the placebo group and n = 37 in the MAS-XR group. The primary outcome was proportion of subjects reporting any marijuana use per study week. Comparisons between groups were made using a logistic mixed effects model incorporating multiple predictors and modeling time-by-treatment interactions.Results: There were no significant baseline differences in marijuana use frequency and quantity. There was a significant decrease in the proportion of participants using marijuana over time in the MAS-XR group, but no difference in the proportion of marijuana-use days over time.Discussion and Conclusions: Treatment of ADHD and comorbid cocaine use disorders with MAS-XR is associated with increased weekly abstinence from marijuana but not with a decrease in the proportion of marijuana using days per week.Scientific Significance: Stimulant treatment of ADHD and cocaine use disorders may diminish co-occurring cannabis use. (Am J Addict 2016;25:666-672). [ABSTRACT FROM AUTHOR]

Objectives: A cuffed tracheostomy tube facilitates prolonged mechanical ventilation and weaning but usually leads to prolonged voicelessness, which can be one of the most negative experiences of hospitalization. No randomized trials have examined the effects of targeted early communication intervention for the restoration of voice in ventilated tracheostomy patients in the ICU.Design: A prospective randomized clinical trial.Setting: The trial was conducted in the ICU of an urban tertiary level hospital.Patients: Thirty adult participants enrolled, with 15 randomly allocated to the intervention and control groups.Interventions: The early intervention group received early cuff deflation and insertion of an in-line speaking valve during mechanical ventilation. The control group received standard cuff deflation and a speaking valve during self-ventilation. A speech-language pathologist provided all treatments.Measurements and Main Results: The primary outcome measure was time from tracheostomy insertion to phonation. Early intervention significantly hastened return to phonation (median difference = 11 d; hazard ratio = 3.66; 95% CI, 1.54-8.68) with no significant effect on duration of tracheostomy cannulation (hazard ratio = 1.40; 95% CI, 0.65-3.03), duration of mechanical ventilation in days from tracheostomy insertion (hazard ratio = 1.19; 95% CI, 0.58-2.51), length of stay in ICU (hazard ratio = 1.16; 95% CI, 0.54-2.52), or time to return to oral intake (hazard ratio = 2.35; 95% CI, 0.79-6.98). Adverse events were low and equal in both groups. There was no significant change in measures of quality of life.Conclusions: Focused early intervention for communication during mechanical ventilation allows the restoration of phonation significantly sooner than standard treatment, with no increase in complications in a small patient cohort. Although these results are favorable, further research is needed to determine whether the effects on any of the secondary outcomes are statistically significant and clinically important. [ABSTRACT FROM AUTHOR]

Background and Objectives: Substance use disorders among youth remain a serious public health problem. Although research has overwhelmingly supported the use of evidenced-based interventions, one of the primary limitations of the current evidence base is that for the vast majority of treatments, the developers of the treatments are also the ones conducting research on them, raising the possibility of allegiance bias.Methods: The present study was an independently conducted randomized controlled trial (n = 126) comparing an evidenced-based treatment for adolescent substance use, Adolescent-Community Reinforcement Approach (A-CRA), and assertive continuing care (ACC), to services as usual (SAU) provided by a juvenile probation department. Latent growth curve modeling was used to compare the treatments on change in substance use assessed by the Global Appraisal of Individual Needs (GAIN) at baseline and 3, 6, and 12 months following treatment entry.Results: All youth evidenced a substantial reduction in substance use frequency and substance-related problems following treatment; however, youth treated with A-CRA/ACC evidenced a substantially greater decrease in substance-related problems.Conclusions and Scientific Significance: Results are consistent with studies conducted by A-CRA/ACC model developers supporting the effectiveness of the clinical approach and, because the outcomes resulted from an independent replication, are encouraging for the transportation potential of A-CRA/ACC. [ABSTRACT FROM AUTHOR]

Background: People with multiple sclerosis have problems with memory and attention. Cognitive rehabilitation is a structured set of therapeutic activities designed to retrain an individual's memory and other cognitive functions. Cognitive rehabilitation may be provided to teach people strategies to cope with these problems, in order to reduce the impact on everyday life. The effectiveness of cognitive rehabilitation for people with multiple sclerosis has not been established.Methods: This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems for people with multiple sclerosis. Four hundred people with multiple sclerosis will be randomised from at least four centres. Participants will be eligible if they have memory problems, are 18 to 69 years of age, are able to travel to attend group sessions and give informed consent. Participants will be randomised in a ratio of 6:5 to the group rehabilitation intervention plus usual care or usual care alone. Intervention groups will receive 10 weekly sessions of a manualised cognitive rehabilitation programme. The intervention will include both restitution strategies to retrain impaired attention and memory functions and compensation strategies to enable participants to cope with their cognitive problems. All participants will receive a follow-up questionnaire and an assessment by a research assistant at 6 and 12 months after randomisation. The primary outcome is the Multiple Sclerosis Impact Scale (MSIS) Psychological subscale at 12 months. Secondary outcomes include the Everyday Memory Questionnaire, General Health Questionnaire-30, EQ-5D and a service use questionnaire from participants, and the Everyday Memory Questionnaire-relative version and Carer Strain Index from a relative or friend. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the MSIS Psychological subscale at 12 months will be used to estimate the effect of the group cognitive rehabilitation programme.Discussion: The study will provide evidence regarding the clinical and cost-effectiveness of a group-based cognitive rehabilitation programme for attention and memory problems in people with multiple sclerosis.Trial Registration: ISRCTN09697576 . Registered 14 August 2014. [ABSTRACT FROM AUTHOR]

Study Objective: The J-Tip (National Medical Products Inc, Irvine, CA) uses air instead of a needle to push lidocaine into the skin. To our knowledge, no studies have investigated its use for venipuncture in young children. We determine whether the J-Tip decreased venipuncture pain in young children compared with vapocoolant spray.Methods: Children aged 1 to 6 years were randomized into 3 groups: intervention (J-Tip), control (vapocoolant spray), and sham (vapocoolant spray and pop of an empty J-Tip). The procedure was videotaped and scored with the Face, Legs, Activity, Cry and Consolability (FLACC) tool at 3 points; baseline, before approach; device, at J-Tip deployment; and at venipuncture. The FLACC tool was scored 0 (none) to 10 (severe). Comparisons of pain scores over time were made with the generalized estimating equation. Venipuncture success and adverse effects were assessed and compared with χ(2).Results: Two hundred five children enrolled: intervention 96, control 53, and sham 56. There were no between-group differences in baseline characteristics. There was no mean change in pain scores from device to venipuncture in the intervention group (0.26; 95% confidence interval [CI] -0.31 to 0.82), but there was an increase in pain in the control (2.82; 95% CI 1.91 to 3.74) and sham (1.68; 95% CI 0.83 to 2.52) groups. This change was greater for the control and sham compared to the intervention group. There was no difference in venipuncture success between groups. No severe adverse events occurred. Minor adverse events were the same between groups.Conclusion: Use of the J-Tip for children aged 1 to 6 years reduced venipuncture pain compared with vapocoolant spray or sham treatment. [ABSTRACT FROM AUTHOR]

Nosocomial pneumonia is common in critically ill patients and is associated with high mortality rates. The development of pneumonia in the intensive care unit (ICU) has been associated with bacterial colonisation within the oral cavity and translocation into the respiratory tract. Over recent years, several strategies have been employed and recommended for preventing ventilator associated pneumonia in the ICU. Chlorhexidine, a topical antiseptic, is a promising agent in preventing nosocomial pneumonia because of its wide antimicrobial spectrum of activity, ease of administration, minimal concerns of contributing to bacterial resistance and relatively benign side effect profile. To evaluate the safety and efficacy of chlorhexidine in preventing nosocomial pneumonia in critically ill patients, we conducted a literature search by using PubMed, EMBASE, CINAHL, Web of Science, and MEDLINE databases; Google Scholar, and the Cochrane Central Register of Controlled Trials (1966– February 2013) for relevant studies. Overall, seven clinical trials were identified. These studies showed mixed results and the majority failed to demonstrate a significant reduction in the incidence of nosocomial pneumonia with the use of chlorhexidine. However, the cardiothoracic surgery ICU patient population may benefit from its use. Further studies are warranted to clearly define the role of chlorhexidine in preventing nosocomial pneumonia. [ABSTRACT FROM PUBLISHER]

Aim To determine pre- and post-dosing effects of prenatal methadone compared to buprenorphine on fetal wellbeing. Design A secondary analysis of data derived from the Maternal Opioid Treatment: Human Experimental Research ( MOTHER) study, a double-blind, double-dummy, randomized clinical trial. Setting Six United States sites and one European site that provided comprehensive opioid-dependence treatment to pregnant women. Participants Eighty-one of the 131 opioid-dependent pregnant women completing the MOTHER clinical trial, assessed between 31 and 33 weeks of gestation. Measurements Two fetal assessments were conducted, once before and once after study medication dosing. Measures included mean fetal heart rate ( FHR), number of FHR accelerations, FHR reactivity in the fetal non-stress test ( NST) and biophysical profile ( BPP) score. Findings Significant group differences were found for number of FHR accelerations, non-reactive NST and BPP scores (all Ps < 0.05). There were no significant group differences before time of dosing. Significant decreases (all Ps < 0.05) occurred from pre- to post-dose assessment for mean FHR, FHR accelerations, reactive NST and fetal movement. The decrease in accelerations and reactive NST were significant only for fetuses in the methadone group, and this resulted in a significantly lower likelihood of a reactive NST compared to fetuses in the buprenorphine group. Conclusion Buprenorphine compared with methadone appears to result in less suppression of mean fetal heart rate, fetal heart rate reactivity and the biophysical profile score after medication dosing and these findings provide support for the relative safety of buprenorphine when fetal indices are considered as part of the complete risk-benefit ratio. [ABSTRACT FROM AUTHOR]

Aim To identify factors that predict the expression of neonatal abstinence syndrome ( NAS) in infants exposed to methadone or buprenorphine in utero. Design and Setting Multi-site randomized clinical trial in which infants were observed for a minimum of 10 days following birth, and assessed for NAS symptoms by trained raters. Participants A total of 131 infants born to opioid dependent mothers, 129 of whom were available for NAS assessment. Measurements Generalized linear modeling was performed using maternal and infant characteristics to predict: peak NAS score prior to treatment, whether an infant required NAS treatment, length of NAS treatment and total dose of morphine required for treatment of NAS symptoms. Findings Of the sample, 53% (68 infants) required treatment for NAS. Lower maternal weight at delivery, later estimated gestational age ( EGA), maternal use of selective serotonin re-uptake inhibitors ( SSRIs), vaginal delivery and higher infant birthweight predicted higher peak NAS scores. Higher infant birthweight and greater maternal nicotine use at delivery predicted receipt of NAS treatment for infants. Maternal use of SSRIs, higher nicotine use and fewer days of study medication received also predicted total dose of medication required to treat NAS symptoms. No variables predicted length of treatment for NAS. Conclusions Maternal weight at delivery, estimated gestational age, infant birthweight, delivery type, maternal nicotine use and days of maternal study medication received and the use of psychotropic medications in pregnancy may play a role in the expression of neonatal abstinence syndrome severity in infants exposed to either methadone or buprenorphine. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Ketamine use in sedation management in patients receiving extracorporeal membrane oxygenation" in the September 12, 2016 issue.

Background: Uterine leiomyomas (fibroid tumors) cause considerable symptoms in 30-50% of women and are the leading cause of hysterectomy in the United States. Women with uterine fibroid tumors often seek uterine-preserving treatments, but comparative effectiveness trials are lacking.Objective: The purpose of this study was to report treatment effectiveness and ovarian function after uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery from the Fibroid Interventions: Reducing Symptoms Today and Tomorrow study.Study Design: The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study, which is a randomized controlled trial of uterine artery embolization vs magnetic resonance imaging-guided focused ultrasound surgery, enrolled premenopausal women with symptomatic uterine fibroid tumors; women who declined randomization were enrolled in a parallel observational cohort. A comprehensive cohort design was used for outcomes analysis. Our target enrollment was 220 women, of which we achieved 41% (n=91) in the randomized and parallel arms of the trial. Primary outcome was reintervention for uterine fibroid tumors within 36 months. Secondary outcomes were change in serum anti-Müllerian hormone levels and standardized measures of fibroid symptoms, quality of life, pain, and sexual function.Results: From 2010-2014, 83 women (mean age, 44.4 years) were treated in the comprehensive cohort design (43 for magnetic resonance imaging-guided focused ultrasound surgery [27 randomized]; 40 for uterine artery embolization [22 randomized]); baseline clinical and uterine characteristics were similar between treatment arms, except for higher fibroid load in the uterine artery embolization arm. The risk of reintervention was higher with magnetic resonance imaging-guided focused ultrasound surgery than uterine artery embolization (hazard ratio, 2.81; 95% confidence interval, 1.01-7.79). Uterine artery embolization showed a significantly greater absolute decrease in anti-Müllerian hormone levels at 24 months compared with magnetic resonance imaging-guided focused ultrasound surgery. Quality of life and pain scores improved in both arms but to a greater extent in the uterine artery embolization arm. Higher pretreatment anti-Müllerian hormone level and younger age at treatment increased the overall risk of reintervention.Conclusion: Our study demonstrates a lower reintervention rate and greater improvement in symptoms after uterine artery embolization, although some of the effectiveness may come through impairment of ovarian reserve. Both pretreatment anti-Müllerian hormone level and age are associated with risk of reintervention.Clinical Trial Registration Number: NCT00995878, clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Background: Uterine fibroids are a common problem for reproductive-aged women, yet little comparative effectiveness research is available to guide treatment choice. Uterine artery embolization and magnetic resonance imaging-guided focused ultrasound surgery are minimally invasive therapies approved by the US Food and Drug Administration for treating symptomatic uterine fibroids. The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study is the first randomized controlled trial to compare these 2 fibroid treatments.Objective: The objective of the study was to summarize treatment parameters and compare recovery trajectory and adverse events in the first 6 weeks after treatment.Study Design: Premenopausal women with symptomatic uterine fibroids seen at 3 US academic medical centers were enrolled in the randomized controlled trial (n = 57). Women meeting identical criteria who declined randomization but agreed to study participation were enrolled in a nonrandomized parallel cohort (n = 34). The 2 treatment groups were analyzed by using a comprehensive cohort design. All women undergoing focused ultrasound and uterine artery embolization received the same postprocedure prescriptions, instructions, and symptom diaries for comparison of recovery in the first 6 weeks. Return to work and normal activities, medication use, symptoms, and adverse events were captured with postprocedure diaries. Data were analyzed using the Wilcoxon rank sum test or χ2 test. Multivariable regression was used to adjust for baseline pain levels and fibroid load when comparing opioid medication, adverse events, and recovery time between treatment groups because these factors varied at baseline between groups and could affect outcomes. Adverse events were also collected.Results: Of 83 women in the comprehensive cohort design who underwent treatment, 75 completed postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization (mean [SD], 405 [146] vs 139 [44] min; P <.001). Of women undergoing focused ultrasound (n = 43), 23 (53%) underwent 2 treatment days. Immediate self-rated postprocedure pain was higher after uterine artery embolization than focused ultrasound (median [interquartile range], 5 [1-7] vs 1 [1-4]; P = .002). Compared with those having focused ultrasound (n = 39), women undergoing embolization (n = 36) were more likely to use outpatient opioid (75% vs 21%; P < .001) and nonsteroidal antiinflammatory medications (97% vs 67%; P < .001) and to have a longer median (interquartile range) recovery time (days off work, 8 [6-14] vs 4 [2-7]; P < .001; days until return to normal, 15 [10-29] vs 10 [10-15]; P = .02). There were no significant differences in the incidence or severity of adverse events between treatment arms; 86% of adverse events (42 of 49) required only observation or nominal treatment, and no events caused permanent sequelae or death. After adjustment for baseline pain and uterine fibroid load, uterine artery embolization was still significantly associated with higher opioid use and longer time to return to work and normal activities (P < .001 for each). Results were similar when restricted to the randomized controlled trial.Conclusion: Women undergoing uterine artery embolization have longer recovery times and use more prescription medications, but women undergoing focused ultrasound have longer treatment times. These findings were independent of baseline pain levels and fibroid load. [ABSTRACT FROM AUTHOR]

Background: Evidence supports that surgeons are at high risk for work-related musculoskeletal disorders.Objective: The objective of the study was to compare the effect of different chairs on work-related musculoskeletal discomfort for surgeons during vaginal operations.Study Design: This crossover study randomly assigned 4 surgeons to 4 chair types using a 4 × 4 Latin square model: a conventional round stool, a round stool with a backrest, a saddle chair with a backrest, and a Capisco chair. Subjective assessments of surgeon discomfort were performed with a validated body discomfort survey, and workload was assessed with the surgical task load index. The objective postural load was quantified with inertial measurement units of the modified rapid upper limb assessment limits. Subjective and objective assessments of chair comfort were performed with an 11 point scale and seat interface pressure-mapped distributions, respectively. The primary outcome was the difference in body discomfort scores between pre- and postsurgery measurements. Secondary outcomes were the differences in chair comfort scores, postural load, and seating interface pressure-mapped distribution. For each outcome, comparisons among the chair types were based on fitting a linear mixed model that handled the surgeon as a random effect and the chair type as a fixed effect.Results: Data were collected for 48 vaginal procedures performed for pelvic organ prolapse. Mean (SD) duration of surgery was 122.3 (25.1) minutes. Surgeons reported body discomfort during 31 procedures (67.4%). Subjective increase in discomfort from the preoperative state was noted most commonly in the lower back (n = 14, 30.4%), followed by right shoulder (n = 12, 26.1%), upper back (n = 8, 17.4%), hips and buttocks (n = 7, 15.2%), left shoulder (n = 6, 13.0%), right or left thigh (n = 6, 13.0%), and neck (n = 6, 13.0%). Pre- and postsurgery body discomfort scores did not differ with respect to chair type. Chair discomfort scores for the round stool and the saddle chair were significantly higher than the round stool with backrest and the Capisco chair (P < .001). Although the average modified rapid upper limb assessment postural scores showed moderate to high musculoskeletal risk of neck and shoulder discomfort across the 4 surgeons; chair type did not affect postural scores. The saddle chair had significantly reduced dispersion of seated pressure vs the round stool with backrest (P ≤ .001), depicted by the number of cells with pressure values >5 mm Hg. An increased dispersion of pressure across the chair surface was associated with increased comfort (Spearman correlation, 0.40, P = .006).Conclusion: Musculoskeletal strain and associated discomfort for surgeons are very high during vaginal operations. Chair type can affect comfort, and chairs with more uniform distribution and fewer pressure points are more comfortable. However, the chair type used in surgery did not influence the musculoskeletal postural load findings. [ABSTRACT FROM AUTHOR]

Background: In infants delivered preterm, magnesium sulfate reduces cerebral palsy in survivors. The benefit of magnesium given remote from delivery is unclear.Objective: Our objective was to evaluate the association of time from last exposure to magnesium with cerebral palsy.Study Design: This was a secondary analysis of a multicenter trial evaluating magnesium for neuroprotection. For this study, we included women with live, nonanomalous, singleton gestations who received magnesium. Pregnancies with missing information at the 2 year follow-up were excluded. Women were divided into 2 groups based on exposure timing: last infusion of magnesium <12 hours and last infusion of magnesium ≥12 hours prior to delivery. The primary outcome was cerebral palsy of any severity at 2 years of life. Secondary outcomes were moderate/severe cerebral palsy and moderate/severe cerebral palsy or death. A χ(2) test, Student t test, and Mann-Whitney U test were used for bivariate associations. We fit a multivariable logistic regression model to adjust for confounders.Results: A total of 906 infants were analyzed. Five hundred sixty-eight were last exposed to magnesium <12 hours prior to delivery and 338 were last exposed ≥12 hours. Cerebral palsy occurred in 28 offspring (3%), 2.3% of those last exposed <12 hours vs 4.4% last exposed ≥12 hours prior to delivery (P = .07). On adjusted analyses, last exposure to magnesium <12 hours prior to delivery was associated with a significant reduction in cerebral palsy compared with last exposure ≥12 hours (adjusted odds ratio, 0.41, 95% confidence interval, 0.18-0.91, P = .03). There was no difference in secondary outcomes.Conclusion: Exposure to magnesium proximal to delivery (<12 hours) is associated with a reduced odds of cerebral palsy compared with more remote exposure. This highlights the importance of the timing of magnesium for neuroprotection for women at risk of preterm delivery. [ABSTRACT FROM AUTHOR]

Background: Astym(®) therapy is a manual therapy intervention used to stimulate tissue healing, decrease pain, improve mobility, and improve muscle performance associated with musculoskeletal pathology. The purpose of this study was to determine if Astym therapy administered to the lower extremity would result in an immediate change of maximal force output during a unilateral isometric squat test among individuals with a lower extremity injury.Methods: Forty-five subjects (14 males; 31 females) between 18 and 65 years of age were randomized into 3 treatment groups: 1) Control group - received no treatment 2) Placebo group - received a sham Astym treatment 3) Astym therapy group- received Astym therapy to the lower extremity. A baseline measure of maximal force output (pre-test) during a unilateral isometric squat was performed. The subjects then received the designated treatment intervention. Immediately following the treatment intervention, maximal force output (post-test) was retested using identical testing procedures by an investigator who was blinded to the treatment intervention received by the subjects. The percent change of maximal force output from pre-test to post-test measures was compared using a one-way analysis of variance. A Tukey's post-hoc analysis determined the statistical differences between the groups.Results: The treatment intervention had a significant effect on the percent change of maximal force output [F(2,42) = 7.91, p = 0.001]. Tukey's post hoc analysis demonstrated that the percent change of maximal force output was significantly greater in the Astym group (15 ± 18 % change of Newtons) compared to the placebo (-6 ± 11 % change of Newtons; p = 0.0001) and control (-1 ± 17 % change of Newtons; p = 0.0014) groups. No significant difference (p = 0.68) was noted between the control and placebo groups.Conclusions: Astym therapy to the involved lower extremity increased maximum force output during an isometric squat test immediately following treatment. The results of this study suggest that Astym therapy can immediately improve muscle performance (maximal force output) for patients presenting with muscular weakness caused by a lower extremity musculoskeletal injury.Trial Registration: Clinicaltrials.gov NCT02349230. Registered 23 January 2015. [ABSTRACT FROM AUTHOR]

Background: Methadone and buprenorphine are recommended to treat opioid use disorders during pregnancy. However, the literature on the relationship between longer-term effects of prenatal exposure to these medications and childhood development is both spare and inconsistent.Methods: Participants were 96 children and their mothers who participated in MOTHER, a randomized controlled trial of opioid-agonist pharmacotherapy during pregnancy. The present study examined child growth parameters, cognition, language abilities, sensory processing, and temperament from 0 to 36 months of the child's life. Maternal perceptions of parenting stress, home environment, and addiction severity were also examined.Results: Tests of mean differences between children prenatally exposed to methadone vs. buprenorphine over the three-year period yielded 2/37 significant findings for children. Similarly, tests of mean differences between children treated for NAS relative to those not treated for NAS yielded 1/37 significant finding. Changes over time occurred for 27/37 child outcomes including expected child increases in weight, head and height, and overall gains in cognitive development, language abilities, sensory processing, and temperament. For mothers, significant changes over time in parenting stress (9/17 scales) suggested increasing difficulties with their children, notably seen in increasing parenting stress, but also an increasingly enriched home environment (4/7 scales) CONCLUSIONS: Findings strongly suggest no deleterious effects of buprenorphine relative to methadone or of treatment for NAS severity relative to not-treated for NAS on growth, cognitive development, language abilities, sensory processing, and temperament. Moreover, findings suggest that prenatal opioid agonist exposure is not deleterious to normal physical and mental development. [ABSTRACT FROM AUTHOR]

Objective: To evaluate 1- and 2-year urinary continence rates after Burch retropubic urethropexy compared with a retropubic midurethral sling for women with urinary incontinence undergoing sacrocolpopexy.Methods: We conducted a planned secondary analysis of a multicenter, randomized, single-blind trial comparing Burch with a sling that enrolled participants from June 2009 to August 2013. Objective outcome measures of continence were assessed at 1- and 2-year follow-up through office visits and validated questionnaires. Overall continence was defined as a negative stress test, no retreatment for stress incontinence, and no self-reported urinary incontinence (International Consultation on Incontinence Questionnaire, Short Form, score, 0). Stress-specific continence was defined as fulfillment of the first two criteria and no self-reported stress-related incontinence. Primary outcomes were assessed with intention-to-treat and within-protocol analyses. Comparisons between groups were evaluated using χ or Fisher exact test.Results: The two groups were similar in all measured baseline features. Outcome assessments at 2 years were available for 48 of 57 patients (84%) in the sling group and 45 of 56 patients (80%) in the Burch group. With intention-to-treat analysis, the sling group had significantly higher rates of overall continence than the Burch group (49% [28/57] vs 29% [16/56]; 95% CI for absolute risk difference 3.0-38.1; P=.03) at 1- but not 2-year follow-up (47% [27/57] vs 32% [18/56]; 95% CI for absolute risk difference -2.6 to 33.1; P=.10). The sling group had significantly higher rates of stress-specific continence than the Burch group at 1-year (70% [40/57] vs 46% [26/56]; 95% CI for absolute risk difference 6.1-41.4; P=.01) and 2-year (70% [40/57] vs 45% [25/56]; 95% CI for absolute risk difference 7.9-43.2; P=.006) follow-up. No difference was detected in prolapse recurrence, voiding dysfunction, antimuscarinic medication use, urgency incontinence, or patient satisfaction.Conclusion: Among women with baseline urinary incontinence undergoing sacrocolpopexy, the retropubic midurethral sling resulted in higher stress-specific continence rates than Burch retropubic urethropexy at 1- and 2-year follow-up. [ABSTRACT FROM AUTHOR]

Background: Opioid Use Disorder (OUD) is a significant public health problem associated with severe morbidity and mortality. While effective pharmacotherapies are available, limitations exist with each. Induction onto extended-release naltrexone (XR-NTX) is more difficult than initiation of buprenorphine or methadone, even in inpatient settings, as it is recommended that patients remain abstinent for at least 7 days prior to initiating XR-NTX. The purpose of this trial was to determine if lorcaserin, a 5HT2c agonist, improves outpatient XR-NTX induction rates.Methods: An 8-week trial beginning with a brief detoxification period and induction onto XR-NTX. Sixty participants with OUD were enrolled in the trial, with 49 participants at the initiation of detoxification randomized to lorcaserin or placebo for 39 days. Additionally, ancillary medications were provided. The primary outcome was the proportion of participants inducted onto the first XR-NTX injection. Secondary outcomes were withdrawal severity (measured by COWS and SOWS) prior to the first injection and the proportion of participants receiving the second XR-NTX injection.Results: The proportion of participants inducted onto the first (lorcaserin: 36 %; placebo: 44 %; p = .67) and the second XR-NTX injection (lorcaserin: 27 %; placebo: 31 %; p = .77) was not significantly different between treatment arms. Prior to the first injection, withdrawal scores did not significantly differ between treatment arms over time (treatment*time interaction COWS: p = .11; SOWS: p = .39).Conclusions: Lorcaserin failed to improve outpatient XR-NTX induction rates. Although this study is small, the findings do not support the use of lorcaserin in promoting induction onto XR-NTX or in mitigating withdrawal symptoms. [ABSTRACT FROM AUTHOR]