Parenteral nutrition and cyclosporine: do lipids make a difference? A prospective randomized crossover trial

AIMS: This prospective, controlled, randomized crossover trial was conducted to assess the effects of parenteral nutrition, with or without lipids, in cyclosporine (CyA) pharmacokinetics. METHODS: 10 adult patients were randomized on the day of allogeneic bone marrow transplantation to receive isocaloric and isonitrogenous parenteral nutrition admixtures without (regimen A) or with lipids (regimen B). Admixtures were started on average by day + 7.4; 5 patients received regimen A followed by B, 5 in reverse order. Blood samples were collected at day 4 after transplantation, under oral diet, and 4 days after the initiation of each regimen as the sole nutrition support. At each time point, 8 whole blood samples were analysed for CyA to evaluate: area under the curve (AUC), trough concentration and systemic clearance. Clinical/laboratory events were recorded until 31 months of follow-up. RESULTS: There was no evidence of a period or treatment-by period interaction, thus results were combined for further analysis. There were no statistically significant differences between regimens in any CyA pharmacokinetic parameters; there were no significant differences from baseline values, except for a higher systemic clearance of CyA with regimen A (0.40+/-0.09 vs 0.29+/-0.06 L/Kg/h, p=0.03). CONCLUSIONS: The provision of 0.8 g/Kg/d of a 50:50 mixture of medium and long chain triglycerides did not affect CyA parameters, which were closer to baseline. In the short or long term there were no attributable side effects.     

Improving on‐time performance in health care organizations: a case study

In this paper, we propose a strategy to build a measurement system that helps improve ontime performance in health care organizations. We analyze the measurement system for monitoring the performance of daily start times of first surgeries in a U.S. hospital. Although surgeons appear to be the main cause of delay, efforts to improve their ontime performance alone are not sufficient to improve ontime performance for first surgeries. Therefore, working on the main source of delay to improve performance, as the Pareto principle suggests, does not always work in the health care context. Rather, we found that ameliorating the hospital's overall ontime performance achieves the desired result of improving surgeons' performance through a snowball effect (a selfreinforcing effect) and, consequently, the ontime performance for first surgeries also improves.     

Polydextrose: its impact on short-term food intake and subjective feelings of satiety in males—a randomized controlled cross-over study

Purpose

Polydextrose is a low-calorie highly branched-chain glucose polymer that is poorly digested in the upper gastrointestinal tract and therefore demonstrates fibre-like properties. Fibre has been shown to increase satiety and possibly reduce food intake. Therefore, the objective of the current study was to examine the effects of polydextrose on short-term satiety and energy intake.

Methods

In a repeated-measures randomized blind cross-over design, 26 healthy males consumed a 400-g fruit smoothie containing 12 g (3 %) of polydextrose, and a buffet lunch 60 min after the smoothie. Motivational ratings for satiety and palatability and lunch energy intake were measured. The effects of the polydextrose-containing smoothie were compared against a polydextrose-free control smoothie.

Results

Polydextrose did not significantly alter the taste and palatability of the fruit smoothie. Consuming the polydextrose-containing smoothie resulted in a significantly lower energy intake at lunch (102 kcal less) compared to the control.

Conclusion

Polydextrose may be a good fortificant for reducing short-term food intake.     

Take a walk in the park? A cross-over pilot trial comparing brisk walking in two different environments: Park and urban

ObjectiveThe objective of the present study is to investigate whether differences exist between a 30 minute brisk walk taken in two different environments in order to determine which environment best facilitates current physical activity guidelines: park or urban.MethodsIn this randomised cross-over pilot study, participants performed a self-timed 30 minute brisk walk in two different environments, park and urban, in Glasgow, Scotland (October 2009 to January 2010). Cadence, recorded using the activPAL? activity monitor, was used to measure intensity. Outcome measures were: mean cadence; moderate-to-vigorous physical activity time accumulated in bouts lasting ≥ 10 min; number of walking breaks; and duration.ResultsA convenience sample of 40 healthy adults was recruited: 16 males, 24 females, mean age 22.9 (5.5) years. The mean cadence for the whole walk was higher in the park: 119.3 (8.3) vs. 110.9 (8.9) steps/min. Participants accumulated more moderate‐to‐vigorous physical activity in ≥ 10 minute bouts during park walks: 25.5 (9.6) [median (interquartile range)] vs. 14.0 (20.3) min. There was no difference in self-timed duration between locations.ConclusionParticipants accumulated more moderate‐to‐vigorous physical activity in bouts ≥ 10 min in duration on park walks due to the lack of interruptions in walking. Hence the park environment better facilitated the achievement of current physical activity guidelines. Further research involving a larger, more heterogeneous sample is recommended.     

The effect of a “training on work readiness” program for workers with musculoskeletal injuries: A randomized control trial (RCT) study

Background: This is a clinical randomized trail (RCT) to investigate the effects of a three-week training program on work readiness designed for musculoskeletal injured workers with long-term sick leave who had difficulties resuming their work role. The program was planned to help injured workers overcome the psychological and psychosocial problems and to facilitate their Work Readiness on Return to Work (RTW) based on the Employment readiness model. Methodology: A total of 64 injured workers were recruited and randomly assigned into the training (T) and control (C) groups. Observations were blinded between service providers and evaluators. A three-week intensive training on work readiness program was given to the T group while subjects in the C group were given advice on job placement by social workers in a community work health center. The training program was comprised of individual vocational counseling and group therapy using cognitive behavioral approach to alleviate symptoms of stress, pain and anxiety. The Chinese Lam Assessment of Stages of Employment Readiness (C-LASER), the Chinese State Trait and Anxiety Inventory (C-STAI) and the Short form of Health Survey (SF-36) were used to evaluate all subjects’ psychological health status and behavioral changes on job readiness before and after the intervention. Results: Subjects in the T group showed significant improvement in their work readiness (p < 0.05), level of anxiety (p < 0.05) and their self perception of health status measured by SF-36 (p < 0.02) when compared with subjects in the C group. Control of chronic pain, negative motivation, and anxiety level were some of the key behavioral changes found from the study. Conclusion: The TWR program appeared to improve injured workers’ motivation and employment readiness. Further study on the employment outcomes of subjects is recommended.     

Immunogenicity and safety of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, compared with Hiberix™ in Korean infants and children: a randomized trial

Background

The World Health Organization (WHO) recommends that all countries adopt Haemophilus influenzae type b (Hib) vaccine into routine child immunization programs to protect children from the significant burden of life-threatening pneumonia and meningitis.

Methods

In this blind, comparative, randomized, phase-III Korean multicenter study, we assessed immunogenicity and safety following primary vaccination of a new H. influenzae type b tetanus toxoid conjugate vaccine, LBVH0101 (LG Life Sciences, Ltd., Seoul, Korea) compared with Hiberix™ (GSK, Rixensart, Belgium) in Korean children at 2, 4 and 6 months of age followed by a booster vaccination at 12–15 months. Serum anti-PRP IgG concentration and bactericidal activity were determined. Local/systemic symptoms were assessed after vaccination. Serious adverse events were recorded throughout the study.

Results

A total of 185 infants were included in immunogenicity evaluations. After the second and third doses of LBVH0101, 90.32% and 100% of infants achieved an antibody level ≥1 μg/mL, respectively, compared with 78.26% and 96.74% of those who received Hiberix™. After the second vaccination, the geometric mean concentration (GMC) of LBVH0101 recipients was 7.34 μg/mL and was higher than that of Hiberix™ recipients (3.55 μg/mL). After the third vaccination, the GMCs were 14.59 μg/mL and 12.15 μg/mL in the LBVH0101 and Hiberix™ recipients, respectively. The booster dose produced higher antibody concentrations: 30.25 μg/mL and 71.64 μg/mL for LBVH0101 and Hiberix™ recipients, respectively. Bactericidal capacity and antibody potency of anti-PRP IgG induced by LBVH0101 was 35.05 and 116.27 after the second and third vaccinations, respectively, compared with 53.76 and 79.64 for Hiberix™. Anti-PRP IgG seroprotection rate and GMC were similar post-primary immunization between the groups; both showed functional maturation and similar booster responses. LBVH0101 had comparable safety results as the control vaccine, Hiberix™, as most of the solicited adverse events and unsolicited adverse events upon LBVH0101 administration were mild in severity. No serious vaccination-related adverse reactions were observed.

Conclusions

LBVH0101 showed a good immunogenicity and safety profile in infants and children. The two-dose infant-priming schedule with a booster dose may suffice for Hib immunization in Korean infants (Clinical trial registration numbers: NCT01019772 and NCT01251133).     

A randomized trial of the impact of a specific care plan in 1120 Alzheimer’s patients (PLASA study) over a two-year period: Design and baseline data

Objectives: To describe the design and baseline patient characteristics of a multicomponent specific care and assistance plan (PLASA) study in Alzheimer’s Disease (AD). The study is designed to evaluate the effect of PLASA in AD primarily looking at change in functional capacity.Design: Two-years prospective cluster randomized controlled trial comparing PLASA and usual care. Setting: Forty-nine hospitals in France.Participants: 1120 community-dwelling AD.Intervention: Patients in the intervention group are evaluated bi-annually using a standardized comprehensive global assessment. In the case of decline in any one domain a standardized study protocol recommends specific physician directed intervention in addition to information and training for the caregiver.Measurements: Alzheimer Disease Cooperative Study-Activities of Daily Living scale, Resource Utilization in Dementia scale, Clinical Global Impression of Change.Results: At baseline, the two groups were similar regarding patient and caregiver characteristics. The mean patient age was 79.61 + 5.72 years and the mean MMSE 19.73 + 4.01 for the whole cohort. Time since dementia diagnosis was about 1.37 + 1.65 years in the whole cohort. Almost a third of the patients lived alone at baseline. Mean monthly time spent in caregiving in the whole cohort was 52.70 + 71.83 hours for instrumental activities and 17.73 + 51.38 hours for basic activities.Conclusion: Persons with dementia suffer different losses at different stages of the disease and therefore accurate assessment of abilities and losses is critical to assist the person in planning for their future and for care needs. The PLASA intervention study is ongoing with 2 year follow-up to be completed in 2007. This research was supported by French Ministry of Health Grant: PHRC 02-006-01. Trial registration: clinicaltrials.gov Identifier: NCT 00480220.     

Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

Background  

Declining physical activity is associated with a rising burden of global disease. There is little evidence about effective ways to increase adherence to physical activity. Therefore, interventions are needed that produce sustained increases in adherence to physical activity and are cost-effective. The purpose is to assess the effectiveness of a primary care physical activity intervention in increasing adherence to physical activity in the general population seen in primary care.     

An energy-restricted high-protein diet supplemented with β-cryptoxanthin alleviated oxidative stress and inflammation in nonalcoholic fatty liver disease: a randomized controlled trial

The efficacy of β-cryptoxanthin (BCX), a high-protein diet (HPD), or both in reducing oxidative stress and inflammation in nonalcoholic fatty liver disease (NAFLD) has never been examined within a randomized controlled trial (RCT). Thus, we aimed to assess the efficacy of an energy-restricted HPD supplemented with BCX in alleviating these conditions in NAFLD in an RCT design. We hypothesized that this combination may improve oxidative stress and inflammation in NAFLD as compared to a standard energy-restricted diet. Ninety-two ultrasonographically confirmed overweight/obese adult NAFLD patients attending an outpatient clinic in Ahvaz, Iran, were recruited for this 12-week, single-center, parallel-group, double-blind RCT from 2017 to 2018. Subjects were randomized into 4 equal groups (n = 23): HPD-BCX (energy-restricted HPD + BCX), HPD (energy-restricted HPD + placebo), BCX (standard energy-restricted diet + BCX), and control (standard energy-restricted diet + placebo). Serum levels of oxidative stress– and inflammation-related markers, as primary outcome measures, were determined at baseline and at the study end point. The 1-way analysis of covariance models in the intention-to-treat population (N = 92) showed that the HPD-BCX group achieved greater 12-week reductions in malondialdehyde, high-sensitivity C-reactive protein, interleukin-6, and total cytokeratin-18 (CK18-M65) but higher increases in total antioxidant capacity and adiponectin compared to the control group (mean differences for malondialdehyde, high-sensitivity C-reactive protein, interleukin-6, total cytokeratin-18, total antioxidant capacity, and adiponectin were −1.9 nmol/mL, −1.0 mg/L, −2.0 ng/L, −270.9 ng/L, 2.5 U/mL, and 1.9 mg/L, respectively; all P < .001). These results show that an energy-restricted HPD supplemented with BCX more efficaciously alleviates oxidative stress and inflammation in NAFLD as compared to a standard energy-restricted diet.