Analysis Of Covariance Model Research Articles

Association Between Recombinant Human Bone Morphogenetic Proteins and Postoperative Opioid Use in Lumbar Fusion Procedure Patients: A Propensity Score-Matched Analysis

Little is known about the effectiveness of recombinant human bone morphogenetic proteins (rhBMPs) in reducing the demand for opioids after surgery. We investigated the association between rhBMP use and the likelihood of achieving opioid independence and changes in opioid demand in the first postoperative year. Using the Multi-Payer Claims Database from 2007 to 2010, patients aged >20 years who had undergone a degenerative disc disease-indicated lumbar fusion procedure and had had ≥1 opioid prescription in the 3 months before surgery were identified. Propensity score matching (1:1) of rhBMP-exposed and rhBMP-unexposed patients was used to mitigate confounding. The outcomes of interest were opioid independence and decreases in opioid doses in morphine equivalent units, assessed at 3-6 and 9-12 months after the procedure. Logistic regression and analysis of covariance models were used. The data from 318 patients were analyzed. Most patients were women (61%) and aged <65 years (68%). Few had achieved opioid independence at 3-6 (n=71; 22.3%) or 9-12 (n= 115; 36.2%) months postoperatively. During the 3-6-month window, the rhBMP group reduced their opioid use rates (estimated mean difference.-28.4 vs.-19.5; P= 0.69) and achieved opioid independence (21.4% vs. 23.3%; odds ratio, 0.92; 95% confidence interval, 0.54-1.56; P= 0.74) at rates that were statistically comparable to their matched comparators. Similar patterns were observed during the 9-12-month window. We found no evidence to suggest that rhBMP use during spinal fusion procedures is associated with either the discontinuation or decrease of opioid analgesic therapy. The continued opioid use after surgery warrants further clinical and research attention.

Relative Contributions of Lean and Fat Mass to Bone Mineral Density: Insight From Prader-Willi Syndrome.

Context: Low bone mineral density (BMD) is the most important risk factor for fragility fracture. Body weight is a simple screening predictor of difference in BMD between individuals. However, it is not clear which component of body weight, lean (LM), or fat mass (FM), is associated with BMD. People with the genetic disorder of Prader-Willi syndrome (PWS) uniquely have a reduced LM despite increased FM.Objective: We sought to define the individual impact of LM and FM on BMD by investigating subjects with and without PWS.Design, Setting and Participants: This cross-sectional study was conducted at the Clinical Research Facility of the Garvan Institute of Medical Research, with PWS and control participants recruited from a specialized PWS clinic and from the general public by advertisement, respectively. The study involved 11 adults with PWS, who were age- and sex-matched with 12 obese individuals (Obese group) and 10 lean individuals (Lean group).Main Outcome Measures: Whole body BMD was measured by dual-energy X-ray absorptiometry. Total body FM and LM were derived from the whole body scan. Differences in BMD between groups were assessed by the analysis of covariance model, taking into account the effects of LM and FM.Results: The PWS group had significantly shorter height than the lean and obese groups. As expected, there was no significant difference in FM between the Obese and PWS group, and no significant difference in LM between the Lean and PWS group. However, obese individuals had greater LM than lean individuals. BMD in lean individuals was significantly lower than in PWS individuals (1.13 g/cm2 vs. 1.21 g/cm2, p < 0.05) and obese individuals (1.13 g/cm2 vs. 1.25 g/cm2, p < 0.05). After adjusting for both LM and FM, there was no significant difference in BMD between groups, and the only significant predictor of BMD was LM.Conclusions: These data from the human genetic model Prader-Willi syndrome suggest that LM is a stronger determinant of BMD than fat mass.

Analyzing pre-post randomized studies with one post-randomization score using repeated measures and ANCOVA models.

The analysis of covariance (ANCOVA) or repeated measures (RM) models are often used to compare the treatment effect between different arms in pre-post randomized studies. ANCOVA adjusts the baseline score as a covariate in regression models. RM treats both the baseline and post-randomization scores as outcome variables. We aim to establish the underlying connections between ANCOVA and a constrained RM ("cRM"). We start with the interrelated concepts in a pre-post randomized designs: homogeneous vs. heterogeneous study populations, the marginal vs. the conditional treatment effect, and homogeneity vs. heterogeneity of treatment effect. We then demonstrate the asymptotic equivalence between the ANCOVA and cRM estimators for the marginal treatment effect and discuss the conditions under which ANCOVA needs to include a baseline score by treatment interaction term. In particular, an ANCOVA interaction model with a mean centered baseline score can assess both the marginal treatment effect and the heterogeneity in the conditional treatment effect. However, the ordinary least squares (OLS)-based inference is not valid for unconditional inference because this interaction model typically has heteroskedastic errors, and ordinary least squares treats the sample mean of the baseline score as a known parameter. We propose a bootstrap and a heteroskedasticity consistent variance estimator for heteroskedastic ANCOVA. Our simulation studies demonstrate that the proposed methods provide valid inferences for testing both the marginal treatment effect and the heterogeneity of treatment effect using an ANCOVA interaction model. We used an acupuncture headache trial to elucidate the proposed approaches.

Abstract 603: Immune response to the influenza vaccination and heart rate variability in breast cancer survivors

Abstract Background: Cancer treatment dysregulates immune function. These effects can persist long after the cessation of therapy and may diminish the immune system's ability to effectively mount an adequate immune response. Latent herpesvirus reactivation may mark a poor immune response to the influenza vaccination. Cancer treatment can also cause adverse effects on cardiac autonomic function as assessed by heart-rate variability (HRV), which is associated with higher morbidity and decreased survival in patients with cancer. Objective: To determine immune response to seasonal influenza vaccination as measured by human cytomegalovirus (CMV) IgG antibody titers and HRV in breast cancer survivors treated with radiation relative to healthy aged-matched controls. Methods: Serum samples for 13 breast cancer survivors within the first year of post-treatment and 13 healthy age-matched controls (mean age 44.7 years) were assayed for CMV IgG antibody titers and heart-rate variability was assessed using MindWare technologies. Group differences between cancer survivors versus healthy individuals were estimated using analysis of covariance (ANCOVA), with adjustment for age, body mass index (BMI) and race. Results: One-way ANCOVA modeling showed that breast cancer survivors treated with radiation had significantly higher antibody titers to CMV relative to age-matched healthy controls (F = 9.15 ; p &amp;lt;.01). While heart rate did not differ among the two groups (F = .36 ; p = .56), high frequency values were significantly lower in breast cancer survivors relative to the healthy controls (HF: F = 10.40 ; p &amp;lt;. 01). Conclusion: Breast cancer survivors manifested a dampened immune response to influenza vaccination and cardiovascular imbalance compared to healthy age-matched controls. These findings have important implications for long-term treatment outcomes. Citation Format: Annina Seiler, Angie S. LeRoy, Christopher P. Fagundes. Immune response to the influenza vaccination and heart rate variability in breast cancer survivors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 603.

Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial.

Background:Substantial muscle atrophy occurs after total knee arthroplasty (TKA), resulting in decreased strength and impaired mobility. We sought to determine whether perioperative supplementation with essential amino acids (EAA) would attenuate muscle atrophy following TKA and whether the supplements were safe for ingestion in an older surgical population.Methods:We performed a double-blind, placebo-controlled, randomized trial of 39 adults (age range, 53 to 76 years) undergoing primary unilateral TKA who ingested 20 g of EAA (n = 19) or placebo (n = 20) twice daily for 7 days preoperatively and for 6 weeks postoperatively. At baseline and 6 weeks postoperatively, magnetic resonance imaging (MRI) scans were obtained to measure quadriceps and hamstrings muscle volume. Secondary outcomes included functional mobility and strength. Data on physical activity, diet, and patient-reported outcomes (Veterans RAND 12-Item Health Survey and Knee injury and Osteoarthritis Outcome Score) were collected. Safety was determined through blood tests evaluating blood urea nitrogen, creatinine, creatinine clearance, homocysteine, and renal and liver function. Laboratory values at baseline, on the day of surgery, and at 2 days, 2 weeks, and 6 weeks postoperatively were compared between treatment groups. Analysis of covariance models, with baseline values as covariates, were used to evaluate outcomes between treatment groups. P values were adjusted for multiple tests.Results:Compared with baseline, the EAA group had significantly less decrease in mean quadriceps muscle volume compared with the placebo group in the involved leg (−8.5% ± 2.5% compared with −13.4% ± 1.9%; p = 0.033) and the contralateral leg (−1.5% ± 1.6% compared with −7.2% ± 1.4%; p = 0.014). The hamstrings also demonstrated a greater muscle-volume-sparing effect for the EAA group than for the placebo group in the involved leg (−7.4% ± 2.0% compared with −12.2% ± 1.4%; p = 0.036) and contralateral leg (−2.1% ± 1.3% compared with −7.5% ± 1.5%; p = 0.005). There were no differences between the groups in terms of functional measures or strength. Blood chemistry values varied significantly between assessments periods but did not statistically differ between groups.Conclusions:The results of the present study suggest that EAA supplementation is safe and reduces the loss of muscle volume in older adults recovering from TKA.Level of Evidence:Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Emotional Distress, Bullying Victimization, and Protective Factors Among Transgender and Gender Diverse Adolescents in City, Suburban, Town, and Rural Locations

Understanding the root causes of the substantial disparities in risk and protective factors among transgender and gender diverse (TGD) adolescents is essential to the development and expansion of resources and supports for this vulnerable population. This study examines differences in emotional distress, bullying victimization, and protective factors among TGD high school students in city, suburban, town, and rural locations. Data come from a statewide school-based survey conducted in Minnesota in 2016 (n = 2,168 TGD youth). Analysis of covariance models were used to predict the prevalence of multiple indicators of emotional distress, bullying victimization, and protective factors across the 4 location categories, with multiple adjustments. Significant linear trends were observed for 2 emotional distress outcomes and 2 bullying victimization outcomes, with urban TGD students having the lowest rates and rural having the highest prevalences. Additional significant differences in emotional distress were noted, with unexpectedly high rates of depressive symptoms and suicidal ideation among suburban students. Helping TGD adolescents in all types of locations identify resources and supportive professionals is critical to supporting this population.

Initial Beta-Hydroxybutyrate Elevation in Relation to Subsequent Weight Loss in Type 2 Diabetes via the SGLT2 Inhibitor Tofogliflozin

The elevation of ketones is clinically concerned in the use of SGLT2 inhibitor (SGLT2i), however little is known about the association between that elevation and subsequent clinical process. We aimed to clarify the association of the initial beta-hydroxybutyrate (BHB) elevation via the SGLT2i, tofogliflozin with subsequent weight loss in type 2 diabetes participants. Analyzed were 774 type 2 diabetes participants who received tofogliflozin in two phase 3 studies. The participants were divided into four groups according to the quartiles for their change in BHB after 4 weeks of tofogliflozin therapy. The adjusted assessments of variables were analyzed using an analysis of covariance model with the quartiles, their baseline values, age, sex, and eGFR as covariates. BHB levels significantly increased (mean: +107.1 µmol/L) from baseline to week 4. Those changes in the first (Q1), second (Q2), third (Q3), and fourth (Q4) quartiles, respectively, were -33.7, +31.4, +98.0, and +331.1 µmol/L. Glycemic control at baseline was poorer, while CPI was lower within the higher quartiles. The difference of BHB changes among the quartiles was maintained during tofogliflozin therapy. At week 52, the increase of BHB levels from baseline was significant (+142.7 µmol/L) in Q4, but not changed in Q1. The weight loss at week 52 in Q4 (least square mean: -3.6 kg) was greater than in Q1 (-2.4 kg) although the improvement of hyperglycemia was identical. Furthermore, the reduction in waist circumference and increase in adiponectin were greater in Q4. And the increase in fasting free fatty acid was also greater in Q4, but not changed in Q1. The distinct response of BHB elevation was observed early after the SGLT2i, tofogliflozin therapy. The higher initial BHB elevation resulted in the greater reduction in body weight, especially fat mass via lipolysis. The progressive weight loss might be clinically associated with one of the signs of the higher ketone elevation. Disclosure Y. Sato: None. K. Nunoi: None. K. Kaku: Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Mitsubishi Tanabe Pharma Corporation, MSD K.K.. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Ono Pharmaceutical Co., Ltd.. Advisory Panel; Self; Sanwa Kagaku Kenkyusho Co., Ltd.. Speaker's Bureau; Self; Taisho Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceuticals, Japan Inc., Kowa Pharmaceuticals, Japan Inc.. Advisory Panel; Self; Astellas, Japan Inc. A. Yoshida: Employee; Self; Kowa Pharmaceutical Co. Ltd. H. Suganami: Employee; Self; Kowa Company, Ltd..

Effects of Ileo-Colonic Delivery of Conjugated Bile Acids on Glucose Metabolism, GLP-1, and Body Weight in Patients with Obesity and Type 2 Diabetes Mellitus—A Randomized Controlled Trial

Bile acid secretion increases significantly after Roux-in-Y gastric bypass and may play a role in weight loss after bariatric surgery. The acute intrajejunal-delivery or intra-rectal delivery of bile acids improves glucose metabolism. We aimed to study the effect of conjugated bile acids released on the ileo-colonic region (IC-CBAS) on glucose metabolism and body weight. In a placebo-controlled, double-blinded, randomized, 28-days trial, we studied the effect of IC-CBAS 500 mg BID on glucose metabolism, incretin hormones (GLP-1 and FGF-19), gastric emptying (scintigraphy) and weight loss in obese type 2 diabetic subjects (n=24 white patients, age=57±2 years, BMI=38.6±1.3 kg/m2, HbA1c=8.5±0.2%, fasting glucose 9.9±0.4 mmol/L). Participants were taking stable doses of DPP-4 inhibitors and metformin and were instructed to continue their current diet and exercise routine. Subjects underwent a meal challenge at baseline and at the end of the treatment period. The primary analyses compared treatment groups at the end of 28 days’ treatment using analysis of covariance models incorporating the corresponding baseline study value as a covariate. IC-CBAS significantly increases postprandial GLP-1 (mean p=0.04, AAB p=0.04), postprandial insulin (AAB p=0.04) and postprandial c-peptide (AAB p=0.01); and decreases fasting insulin (p=0.04) when compared to placebo. IC-CBAS also induced a numerically (but not statistically significantly) improvement in fasting glucose (delta -16 mg/dl), postprandial glucose (delta mean -14 mg/dl) and weight (delta -0.45±.4 kg) compared to placebo. There were no reported side effects, or dropouts; and no difference in FGF-19, gastric emptying or number of bowel movements. IC-CBAS 28-day treatment results in significant increase in GLP-1 and postprandial insulin, suggesting a beneficial role in incretins, insulin and glucose homeostasis. Disclosure G. Calderon Manrique: None. J. Davis: None. A.N. Bonis: None. D. Khemani: None. B. Gedulin: None. A. Vella: Research Support; Self; Novo Nordisk Inc., XOMA Corporation. Advisory Panel; Self; VTV Therapeutics, Bayer AG. M. Camilleri: None. A. Acosta: None.

Factors impacting the efficacy of venlafaxine extended release 75-225 mg/day in patients with major depressive disorder: exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study in Japan.

PurposeTo explore the potential factors impacting the efficacy of venlafaxine extended release (ER) and treatment differences between 75 mg/day and 75–225 mg/day dose in patients with major depressive disorder (MDD).MethodsWe performed exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study conducted in Japan. A total of 538 outpatients aged 20 years or older with a primary diagnosis of MDD who experienced single or recurrent episodes were randomized into three groups: fixed-dose, flexible-dose, or placebo. Venlafaxine ER was initiated at 37.5 mg/day and titrated to 75 mg/day for both fixed-dose and flexible-dose group, and to 225 mg/day for flexible-dose group (if well tolerated). Efficacy endpoints were changes from baseline at Week 8 using the Hamilton Rating Scale for Depression–17 items (HAM-D17) total score, Hamilton Rating Scale for Depression–6 items score, and Montgomery–Asberg Depression Rating Scale total score. The following factors were considered in the subgroup analyses: sex, age, HAM-D17 total score at baseline, duration of MDD, duration of current depressive episode, history of previous depressive episodes, history of previous medications for MDD, and CYP2D6 phenotype. For each subgroup, an analysis of covariance model was fitted and the adjusted mean of the treatment effect and corresponding 95% CI were computed. Due to the exploratory nature of the investigation, no statistical hypothesis testing was used.ResultsVenlafaxine ER improved symptoms of MDD compared with placebo in most subgroups. The subgroup with a long duration of MDD (>22 months) consistently showed greater treatment benefits in the flexible-dose group than in the fixed-dose group.ConclusionThese results suggest that a greater treatment response to venlafaxine ER (up to 225 mg/day) can be seen in patients with a longer duration of MDD. Further investigations are needed to identify additional factors impacting the efficacy of venlafaxine ER.

Explaining Lord's Paradox in Introductory Statistical Theory Courses

When two groups are compared in a pre-post study, two different conclusions can be drawn between the two-sample t-test and the analysis of covariance (ANCOVA). It is known as Lord's Paradox, and it occurs because the parameter in the two-sample t-test and the parameter of interest in the ANCOVA model are not the same quantity. The difference between the two parameters can be explained by the covariance of linearly combined random variables which is an important topic in introductory statistical theory courses. Lord's paradox is frequently observed in practice, and it is very important for students (future researchers) to have clear understanding of the paradox. The objective of this article is to explain Lord's Paradox using the covariance of linearly combined random variables. The paradox is explained using three scenarios in the context of educational research. The first scenario is when the average baseline (pre-score) is greater in the treatment group than the control group, the second scenario is when the average baseline is lower in the treatment group than the control group, and the third scenario is when the average baseline is same between the two groups by randomization. This article is written at the level of introductory statistical theory courses for undergraduate and graduate statistics students to help understanding the difference between the parameter of interest in the two-sample t-test and the parameter of interest in the ANCOVA model.

Health-Related Quality of Life in Patients with Arthritis: A Cross-Sectional Survey among Middle-Aged Adults in Chongqing, China.

Background: Arthritis is a common disease in China, but few studies have been conducted to explore the associated health-related quality of life (HRQoL) and its influencing factors in Chongqing, China. This study aimed to explore the association of arthritis and HRQoL and probe factors affecting HRQoL among arthritis patients. Methods: A cross-sectional survey was conducted in Chongqing, China. A total of 1224 adults were included in the analysis. Medical Outcomes Study Short Form 36 Health Survey (SF-36) was used to measure HRQoL. Multiple linear regression models (stepwise) and covariance analysis models were used to examine the association of arthritis with HRQoL and analyze factors associated with HRQoL among arthritis patients. Results: Participants with arthritis had poorer HRQoL than those without. Among arthritis patients, the female was associated with a poorer state of physical functioning (p < 0.05); unemployed patients had a poorer state of role-physical than employed patients (p < 0.05); low average monthly income was associated with a poorer state of physical functioning (p < 0.01); childhood non-breastfeeding history was associated with a poorer state of social functioning (p < 0.01); average or dissatisfied attitude to current living conditions was associated with a poorer state of vitality and mental health (p < 0.05 for all); moreover, poor or general appetite was associated with a poorer state of role-physical, general health, social functioning, bodily pain, and role-emotional (p < 0.01 for all). Conclusions: Arthritis patients have worse HRQoL than those without in the Chinese population. Female, low socioeconomic status, childhood non-breastfeeding history, average or dissatisfied attitude to current living conditions and poor or general appetite were associated with poorer state of HRQoL among Chinese arthritis patients.

Effect of phytate and zinc ions on fluoride toothpaste efficacy using an in situ caries model

ObjectivesTo compare and explore the dose-response of phytate-containing 1150 ppm fluoride toothpastes on model caries lesions and to determine the impact of zinc ions. MethodsThis was a single-centre, randomised, blinded (examiner/laboratory analyst), six-treatment, four-period crossover, in situ study in adults with a removable bilateral maxillary partial denture. Study treatments were toothpastes containing: 0.425% phytate/F; 0.85% phytate/F; 0.85% phytate/Zn/F; F-only; Zn/F and a 0% F placebo. Where present, F was 1150 ppm as NaF; Zn was 0.3% as ZnCl2. Human enamel specimens containing early-stage, surface-softened (A-lesions) or more advanced, subsurface (B-lesions) caries lesions were placed into the buccal flanges of participants’ modified partial denture (one of each lesion type per side). A-lesions were removed after 14 days of twice-daily treatment use; B-lesions were removed after a further 14 days. A-lesions were analysed for surface microhardness recovery. Both lesion types were analysed by transverse microradiography and for enamel fluoride uptake, with B-lesions additionally analysed by quantitative light-induced fluorescence. Comparison was carried out using an analysis of covariance model. ResultsStatistically significant differences between 1150 ppm F and the placebo toothpastes (p < 0.05) were shown for all measures, validating the model. No differences between fluoride toothpastes were observed for any measure with little evidence of a dose-response for phytate. Study treatments were generally well-tolerated. ConclusionsResults suggest phytate has little impact on fluoride’s ability to promote early-stage lesion remineralisation or prevent more advanced lesion demineralisation in this in situ caries model. Similarly, results suggest zinc ions do not impair fluoride efficacy. Clinical significanceToothpastes may contain therapeutic or cosmetic agents that could interfere with fluoride’s caries prevention efficacy. The present in situ caries study has demonstrated that phytate, added to provide enhanced extrinsic stain removal/prevention, and zinc, added to inhibit malodour, do not impair fluoride efficacy.

Assessment of co-seismic landslide susceptibility using LR and ANCOVA in Barpak region, Nepal

Nepal was affected by a catastrophic earthquake with Mw 7.8 on 25th April, 2015 with its epicenter in the central part of Barpak village. A number of co-seismic landslides were triggered by the main shock of the event and associated aftershocks. Due to the rugged topography and vicinity of the main shock, the village was extremely affected by co-seismic landslides. In total, 59 landslides were identified using Google Earth and were verified during the field survey in Barpak village. Furthermore, 11 conditioning factors, including Peak ground acceleration (PGA), epicenter proximity, fault proximity, geology, slope, elevation, plan curvature, profile curvature, topographic wetness index, drainage proximity and the sediment transport index were selected as independent variables for analysis. In this study, logistic regression (LR) and analysis of covariance (ANCOVA) models were used and their performance was assessed. Finally, the landslide susceptibility classes were produced and an evaluation of models was done by using receiver operating characteristic curves. The area under the curve for LR and ANCOVA showed 85.38 and 78.4% accuracy, respectively. Based on the overall assessments, the LR model was more accurate than the ANCOVA model for co-seismic landslide prediction in the study area. The result of this study can be used to mitigate landslide-induced hazards and for land-use planning.

Poor Sleep Quality is Associated with Insulin Resistance in Postmenopausal Women With and Without Metabolic Syndrome.

Poor sleep quality has previously been shown to be related to insulin resistance in apparently healthy adults. However, it is unclear whether an association between sleep quality and insulin resistance exists among adults with metabolic syndrome (MetS). Participants included 347 overweight/obese postmenopausal women without type 2 diabetes (age: 57.5 ± 6.5 years; body mass index [BMI]: 31.7 ± 3.7 kg/m2; 54% with MetS). Sleep quality was assessed with the six-item Medical Outcomes Study Sleep Scale; values were categorized into quartiles. Insulin resistance was calculated from fasting glucose and insulin with the homeostasis model assessment of insulin resistance (HOMA2-IR) method. Analysis of covariance models were used to examine the association between sleep quality and HOMA2-IR after accounting for MetS and covariates (e.g., BMI, cardiorespiratory fitness, and energy intake). Women with the worst sleep quality had significantly higher HOMA2-IR values than women in all other quartiles (P ≤ 0.05 for each), and women with MetS had significantly higher HOMA2-IR values than women without MetS (P < 0.0001), but the relationship between sleep quality and HOMA2-IR did not differ between those with or without MetS (P = 0.26). Women with MetS in the worst quartile of sleep quality had higher HOMA2-IR values than all other women (P < 0.02). Taking >30 min to fall asleep, frequent restless sleep, and frequent daytime drowsiness were each related to higher HOMA2-IR values (each P < 0.04). Sleep quality is an important correlate of insulin resistance in postmenopausal women with and without MetS. Intervention studies are needed to determine whether improving sleep improves insulin resistance in populations at elevated cardiometabolic risk.

Effect of a Suspension-Trainer-Based Movement Program on Measures of Fitness and Functional Movement in Children: A Pilot Study.

The purpose of this pilot study was to assess the efficacy of a suspension-training movement program to improve muscular- and skill-related fitness and functional movement in children, compared with controls. In total, 28 children [male: 46%; age: 9.3 (1.5) y; body mass index percentile: 68.6 (27.5)] were randomly assigned to intervention (n = 17) or control (n = 11) groups. The intervention group participated in a 6-week suspension-training movement program for two 1-hour sessions per week. Muscular- and skill-related fitness and functional movement assessments were measured at baseline and following the intervention. Analyses of covariance models were used to assess the effects of time and intervention. The intervention participants achieved greater improvements in Modified Pull-Up performance (P = .01, Cohen's d = 0.54) and Functional Movement Screen score (P < .001, Cohen's d = 1.89), relative to controls. The suspension-training intervention delivered twice a week was beneficial for upper body pulling muscular endurance and the Functional Movement Screen score. Future interventions using this modality in youth would benefit from larger, more diverse samples (through schools or community fitness centers) and a longer intervention length.

Strength and cardiometabolic risk in young adults: The mediator role of aerobic fitness and waist circumference.

The aim of this study was to analyze the mediation role of cardiorespiratory fitness and waist circumference in the association between muscular strength and cardiometabolic risk. A cross-sectional study involved first-year college students (n=370) from a Spanish public university was performed. We measured weight, height, waist circumference, blood pressure, biochemical variables, maximum handgrip strength assessment, and cardiorespiratory fitness. We calculated handgrip dynamometry/weight and a previously validated cardiometabolic risk index. Analysis of covariance models was conducted to test differences in cardiometabolic risk values across muscular strength, cardiorespiratory fitness, and waist circumference categories, controlling for confounders. Hayes' PROCESS macro was used for the multiple mediation analysis. The relationship between muscular strength and cardiometabolic risk did not remain significant (c'=1.76 [1.4]; P>.05) in a multiple serial bootstrapped mediation model including cardiorespiratory fitness and waist circumference as mediators when controlling for age and sex. According to the indirect effect, the significant paths in the model mediating this relationship between muscular strength and cardiometabolic risk index were as follows: muscular strength → waist circumference → cardiometabolic risk index (-4.899; 95% CI: -6.690; -3.450) and muscular strength → cardiorespiratory fitness → waist circumference → cardiometabolic risk index (-0.720; 95% CI: -1.316; -0.360). Both cardiorespiratory fitness and waist circumference mediate the association between muscular strength and cardiometabolic risk in young adults. Thus, our results place cardiorespiratory fitness and waist circumference as the main targets of physical activity programmes aimed at preventing cardiometabolic diseases.

Associations between healthcare worker participation in workplace wellness activities and job satisfaction, occupational stress and burnout: a cross-sectional study in Botswana

ObjectivesHealthcare workers (HWs) are prone to high levels of stress and burnout, particularly when caring for people with HIV/AIDS. This study assessed whether participation in Botswana’s Workplace Wellness Programme (WWP)...

The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial

BackgroundOrally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure.MethodsA total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42 weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1 ml (Group 1; n = 81), 0.5 ml (Group 2; n = 81), or 1.0 ml (Group 3; n = 83). The primary outcome was pain intensity measured at 30 and 60 s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups.ResultsThere was no difference in mean pain intensity PIPP-R scores between treatment groups at 30 s (P = .97) and 60 s (P = .93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (P = .62). All events resolved spontaneously without medical intervention.ConclusionsThe minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1 ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted.Trial registrationClinicalTrials.gov: NCT02134873. Date: May 5, 2014 (retrospectively registered).

Testing in nonparametric ANCOVA model based on ridit reliability functional

In the spirit of Bross (Biometrics 14:18–38, 1958), this paper considers ridit reliability functionals to develop test procedures for the equality of $$K(>2)$$ treatment effects in nonparametric analysis of covariance (ANCOVA) model with d covariates based on two different methods. The procedures are asymptotically distribution free and are not based on the assumption that the distribution functions (d.f.’s) of the response variable and the associated covariates are continuous. By means of simulation study, the proposed methods are compared with the methods provided by Tsangari and Akritas (J Multivar Anal 88:298–319, 2004) and Bathke and Brunner (Recent advances and trends in nonparametric statistics, Elsevier, Amsterdam, 2003) under ANCOVA in terms of type I error rate and power.

Evaluation of the safety and efficacy of an intravenous nanocrystal formulation of meloxicam in the management of moderate-to-severe pain after bunionectomy.

ObjectiveThis randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of an intravenous (IV) nanocrystal formulation of meloxicam in subjects with moderate-to-severe pain following a standardized unilateral bunionectomy.MethodsFifty-nine subjects aged 18–72 years were randomized to receive doses of either 30 mg (n=20) or 60 mg (n=20) meloxicam IV or placebo (n=19), administered once daily as bolus IV injections over 15–30 seconds (two or three doses). Safety, the primary objective, was assessed by physical examination, clinical laboratory tests, and the incidence of adverse events (AEs). Efficacy was evaluated by examining summed pain intensity differences over the first 48 hours (SPID48) using analysis of covariance models. Use of opioid rescue analgesic agents was evaluated.ResultsGenerally, AEs were mild-to-moderate in intensity, and their incidence was similar across the three treatment groups. No serious AEs were reported; there were no withdrawals due to AEs, including injection-related AEs. The estimated effect size for SPID48 versus placebo was 1.15 and 1.01 for meloxicam IV doses 30 mg and 60 mg, respectively (P≤0.01). Both doses produced significantly greater pain reductions versus placebo (P≤0.05) at all evaluated times/ intervals during the 48-hour period. The proportions of subjects with ≥30% and ≥50% overall reduction in pain from baseline after 6 and 24 hours were significantly higher with meloxicam IV 30 mg doses versus placebo, but not with meloxicam IV 60 mg doses. The time to first use of rescue medication was significantly longer versus placebo with meloxicam IV 60 mg (P<0.05), but not with meloxicam IV 30 mg doses.ConclusionMeloxicam IV was generally safe and well tolerated in subjects with moderate-to-severe post-bunionectomy pain. Once-daily administration of meloxicam IV 30 mg and 60 mg exhibited rapid onset of analgesia (as early as 15 minutes) with maintenance of analgesic effect for two consecutive 24-hour periods.