It is unclear whether gestational diabetes mellitus (GDM) alters breast milk composition. We prospectively examined associations of GDM status with concentrations of six potentially bioactive ...elements (glucose, insulin, C-reactive protein (CRP), interleukin-6 (IL-6), leptin, and adiponectin) in human milk. These were measured at both 1 and 3 months postpartum in 189 fully breastfeeding women. Mixed-effects linear regression assessed GDM status-related differences in these milk bioactives, adjusting for demographics, maternal factors, and diet. At 1 and 3 months postpartum, milk CRP was higher (1.46 ± 0.31 ng/mL; p < 0.001 and 1.69 ± 0.31 ng/mL; p < 0.001) in women with GDM than in women without GDM, whereas milk glucose (−5.23 ± 2.22 mg/dL; p = 0.02 and −5.70 ± 2.22; p = 0.01) and milk insulin (−0.38 ± 0.17 μIU/mL; p = 0.03 and −0.53 ± 0.17; p = 0.003) were lower in women with GDM. These significant associations remained similar after additional adjustment for maternal weight status and its changes. No difference was found for milk IL-6, leptin, and adiponectin. There was no evidence of association between these milk bioactive compounds and 1 h non-fasting oral glucose challenge serum glucose in the women without GDM. This prospective study provides evidence that potentially bioactive elements of human milk composition are altered in women with GDM.
Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered ...multifactorial fall injury prevention strategy to an enhanced usual care.
Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 health care systems across United States. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by health care system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a comanagement model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (nonvertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control.
Trial enrolled 5,451 subjects in 20 months. Intervention and follow-up are ongoing.
The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults.
Diagnosing anal squamous cell carcinoma (SCC), which is often preceded by anal intraepithelial neoplasia (AIN), may be challenging in small biopsies. Cytokeratin 17 (CK17) is a basal/myoepithelial ...cell keratin induced in activated keratinocytes and associated with disease progression in SCC of the uterine cervix, esophagus, and oral cavity. We investigated the utility of CK17 in diagnosing invasion in anal squamous neoplastic lesions. Immunohistochemical staining for CK17 was evaluated in 11 AINs, 12 invasive SCCs, 8 invasive SCCs with basaloid features (BSCC), and 2 invasive pure basaloid carcinomas. The pattern of staining was scored as surface/central, peripheral/rim, diffuse, or absent. All cases of invasive SCC and BSCC stained positive for CK17. Eleven of 12 (92%) SCCs showed diffuse staining, and 1 of 12 (8%) showed peripheral staining. Six of 8 (75%) BSCCs showed diffuse staining, and 2 of 8 (25%) showed peripheral staining. Both pure basaloid carcinomas were negative for CK17. One of 11 (9%) AINs was diffusely positive for CK17; all other AINs had surface or absent CK17. Of the 6 patients with concurrent AIN and invasive carcinoma, superficial expression of CK17 was present in 1 AIN, whereas all invasive components showed diffuse staining. The sensitivity and specificity of CK17 for identifying invasion in SCC and BSCC was 100% and 91%, respectively. Peripheral or diffuse staining for CK17 is a useful marker of invasion in anal squamous neoplastic lesions. A potential pitfall in the utility of CK17 is that the pure basaloid variant of anal carcinoma is negative for CK17.
Conventional veterinary training emphasizes correct methodologies, potentially failing to exploit learning opportunities that arise as a result of errors. Error management training (EMT) encourages ...mistakes during low-stakes training, with the intention of modifying perceptions toward errors and using them to improve performance in unfamiliar scenarios (adaptive transfer). Herein, we aimed to determine the efficacy of EMT, supplemented by a metacognitive module, for veterinary students learning blood smear preparation and interpretation. Our hypothesis was that EMT and metacognition are associated with improved adaptive transfer performance, as compared with error avoidance training (EAT). A total of 26 students were prospectively enrolled in this double-blind study. Performance was evaluated according to monolayer area, smear quality, cell identification, calculated white blood cell differential counts, and overall application/interpretation. Students were trained with normal canine blood and static photomicrographs. Participants tested 72 hours after training demonstrated improved performance in a test that directly recapitulated training (Wilcoxon matched-pairs signed-rank test; two-tailed
all ≤ .001). There were no significant differences between EAT and EMT in this test (Mann-Whitney
test and Welch's
-test; two-tailed
.26) or in short- and long-term adaptive transfer tests (
.22). Survey data indicate that participants found errors to be a valuable element of training, and that many felt capable of accurately reflecting on their own performance. These data suggest that EMT might produce outcomes comparable to EAT as it relates to blood smear analysis.
BACKGROUND/OBJECTIVES
In the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to ...first serious fall injury but a significant 10% reduction in time to first self‐reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well‐being including concern about falling, anxiety, depression, physical function, and disability.
DESIGN
Pragmatic cluster‐randomized trial of 5,451 community‐living persons at high risk for serious fall injuries.
SETTING
A total of 86 primary care practices within 10 U.S. healthcare systems.
PARTICIPANTS
A random subsample of 743 persons aged 75 and older.
MEASUREMENTS
The well‐being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient‐Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late‐Life Function and Disability Instrument.
RESULTS
Participants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: −1.19 (99% confidence interval, −2.36 to −.02), with 3.5 points representing a minimally important difference.
CONCLUSIONS
STRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well‐being.
In response to the epidemic of falls and serious falls‐related injuries in older persons, in 2014, the Patient Centered Outcomes Research Institute (PCORI) and the National Institute on Aging funded ...a pragmatic trial, Strategies to Reduce Injuries and Develop confidence in Elders (STRIDE) to compare the effects of a multifactorial intervention with those of an enhanced usual care intervention. The STRIDE multifactorial intervention consists of five major components that registered nurses deliver in the role of falls care managers, co‐managing fall risk in partnership with patients and their primary care providers (PCPs). The components include a standardized assessment of eight modifiable risk factors (medications; postural hypotension; feet and footwear; vision; vitamin D; osteoporosis; home safety; strength, gait, and balance impairment) and the use of protocols and algorithms to generate recommended management of risk factors; explanation of assessment results to the patient (and caregiver when appropriate) using basic motivational interviewing techniques to elicit patient priorities, preferences, and readiness to participate in treatments; co‐creation of individualized falls care plans that patients’ PCPs review, modify, and approve; implementation of the falls care plan; and ongoing monitoring of response, regularly scheduled re‐assessments of fall risk, and revisions of the falls care plan. Custom‐designed falls care management software facilitates risk factor assessment, the identification of recommended interventions, clinic note generation, and longitudinal care management. The trial testing the effectiveness of the STRIDE intervention is in progress, with results expected in late 2019.
Abstract
To determine parity effects on late gestational uteroplacental blood flow, uterine artery hemodynamics were measured in 13 primiparous and 11 multiparous (parity 3 and 4) non-lactating, ...fall-calving crossbred females beginning 109 d prepartum. Females were nutritionally managed as one group to meet or exceed nutrient requirements. Transrectal color Doppler ultrasonography of the both uterine arteries was conducted 3 to 6 times per female across late gestation, ending at approximately 20 d prepartum. Data were analyzed with parity (primiparous vs. multiparous), day prior to calving, and their interaction in the model; day was a repeated effect. Dam BW was greater (P < 0.001) for multiparous than primiparous females, and increased (P = 0.004) as gestation progressed. Calf birth weight was unaffected (P = 0.87) by parity. The parity x day interaction tended to affect (P = 0.06) ipsilateral uterine artery blood flow (L/min), where multiparous cows had a greater increase per day. Total and contralateral uterine artery blood flow were unaffected (P ≥ 0.11) by parity, but increased (P < 0.001) with day of gestation. When expressed relative to dam BW, total and contralateral blood flow were greater (P ≤ 0.04) in primiparous than multiparous females; ipsilateral blood flow was unaffected (P ≥ 0.13) by parity, however. Ipsilateral pulsatility index and both resistance indices were unaffected (P ≥ 0.28) by parity and day, but day tended to affect (P = 0.07) contralateral pulsatility index. Parity did not affect (P ≥ 0.11) cross-sectional area, mean velocity, peak systolic velocity, and end diastolic velocity of either uterine artery, but all increased (P < 0.001) as gestation progressed. Heart rate was greater (P = 0.03) in primiparous than multiparous females. Data suggest that uterine artery blood flow and heart rate may be altered in primiparous females, even when birth weight is unaffected by parity.
Taverna is an application that eases the use and integration of the growing number of molecular biology tools and databases available on the web, especially web services. It allows bioinformaticians ...to construct workflows or pipelines of services to perform a range of different analyses, such as sequence analysis and genome annotation. These high-level workflows can integrate many different resources into a single analysis. Taverna is available freely under the terms of the GNU Lesser General Public License (LGPL) from http://taverna.sourceforge.net/.
Obesity has significant health and NHS cost implications. Relatively small reductions in weight have clinically important benefits, but long-term weight loss maintenance (WLM) is challenging. ...Behaviour change interventions have been identified as key for WLM. Motivation is crucial to supporting behaviour change, and motivational interviewing (MI) has been identified as a successful approach to changing health behaviours. The study was designed as an adequately powered, pragmatic randomised controlled trial (RCT); however, owing to recruitment issues, the study became a feasibility trial.
To assess recruitment, retention, feasibility, acceptability, compliance and delivery of a 12-month intervention to support WLM. Secondary objectives were to assess the impact of the intervention on body mass index (BMI) and other secondary outcomes.
Three-arm individually randomised controlled trial comprising an intensive arm, a less intensive arm and a control arm.
Community setting in South Wales and the East Midlands.
Individuals aged 18-70 years with a current or previous BMI of ≥ 30 kg/m(2) who could provide evidence of at least 5% weight loss during the previous 12 months.
Participants received individually tailored MI, which included planning and self-monitoring. The intensive arm received six face-to-face sessions followed by nine telephone sessions. The less intensive arm received two face-to-face sessions followed by two telephone sessions. The control arm received a leaflet advising them on healthy lifestyle.
Feasibility outcomes included numbers recruited, retention and adherence. The primary effectiveness outcome was BMI at 12 months post randomisation. Secondary outcomes included waist circumference, waist-to-hip ratio, physical activity, proportion maintaining weight loss, diet, quality of life, health service resource usage, binge eating and well-being. A process evaluation assessed intervention delivery, adherence, and participants' and practitioners' views. Economic analysis aimed to assess cost-effectiveness in terms of quality-adjusted life-years (QALYs).
A total of 170 participants were randomised. Retention was good (84%) and adherence was excellent (intensive, 83%; less intensive, 91%). The between-group difference in mean BMI indicated the intensive arm had BMIs 1.0 kg/m(2) lower than the controls 95% confidence interval (CI) -2.2 kg/m(2) to 0.2 kg/m(2). Similarly, a potential difference was found in weight (average difference of 2.8 kg, 95% CI -6.1 kg to 0.5 kg). The intensive arm had odds of maintaining on average 43% odds ratio(OR) 1.4, 95% CI 0.6 to 3.5 higher than controls. None of these findings were statistically significant. Further analyses controlling for level of adherence indicated that average BMI was 1.2 kg/m(2) lower in the intensive arm than the control arm (95% CI -2.5 kg/m(2) to 0.0 kg/m(2)). The intensive intervention led to a statistically significant difference in weight (mean -3.7 kg, 95% CI -7.1 kg to -0.3 kg). The other secondary outcomes showed limited evidence of differences between groups. The intervention was delivered as planned, and both practitioners and participants were positive about the intervention and its impact. Although not powered to assess cost-effectiveness, results of this feasibility study suggest that neither intervention as currently delivered is likely to be cost-effective in routine practice.
This is the first trial of an intervention for WLM in the UK, the intervention is feasible and acceptable, and retention and adherence were high. The main effectiveness outcome showed a promising mean difference in the intensive arm. Owing to the small sample size, we are limited in the conclusions we can draw. However, findings suggest that the intensive intervention may facilitate long-term weight maintenance and, therefore, further testing in an effectiveness trial may be indicated. Research examining WLM is in its infancy, further research is needed to develop our understanding of WLM and to expand theory to inform the development of interventions to be tested in rigorously designed RCTs with cost-effectiveness assessed.
Current Controlled Trials ISRCTN35774128.
This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 50. See the NIHR Journals Library website for further project information.
PDF
