“Optimal surfactant delivery protocol using the bovine lipid extract surfactant: a quality improvement study”
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ABSTRACT:
SUBMITTER: Germain A
PROVIDER: S-EPMC7532933 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo compare the efficacy and safety of poractant alfa and bovine lipid extract surfactant in preterm infants.Study designRandomized, partially-blinded, multicenter trial. Infants <32 weeks needing surfactant before 48 hours were randomly assigned to receive poractant alfa or bovine lipid extract surfactant. The primary outcome was being alive and extubated at 48 hours post-randomization. Secondary outcomes included need for re-dosing, duration of respiratory support and oxygen, bronchopulmonary dysplasia, mortality and complications during administration.ResultsThree centers recruited 87 infants (mean 26.7 weeks and 906 grams) at a mean age of 5.9 hours, between March 2013 and December 2015. 21/42 (50%) were alive and extubated at 48 hours in the poractant alfa group vs 26/45 (57.8%) in the bovine lipid extract surfactant group; adjusted OR 0.76 (95% CI 0.30-1.93) (p = 0.56). No differences were observed in the need to re-dose. Duration of oxygen support (41.5 vs 62 days; adjusted OR 1.69 95% CI 1.02-2.80; p = 0.04) was reduced in infants who received poractant alfa. We observed a trend in bronchopulmonary dysplasia among survivors (51.5% vs 72.1%; adjusted OR 0.35 95%CI 0.12-1.04; p = 0.06) favoring poractant alfa. Twelve infants died before discharge, 9 in the poractant alfa group and 3 in the bovine lung extract group. Severe airway obstruction following administration was observed in 0 (poractant alfa) and 5 (bovine lipid extract surfactant) infants (adjusted OR 0.09 95%CI <0.01-1.27; p = 0.07).ConclusionNo statistically significant difference was observed in the proportion of infants alive and extubated within 48h between the two study groups. Poractant alfa may be more beneficial and associated with fewer complications than bovine lipid extract surfactant. However, we observed a trend towards higher mortality in the poractant alfa group. Larger studies are needed to determine whether observed possible benefits translate in shorter hospital admissions, or other long term benefits and determine whether there is a difference in mortality.
| S-EPMC5417427 | biostudies-literature
Project description:ObjectiveTo test a multifaceted collaborative quality improvement intervention designed to promote evidence based surfactant treatment for preterm infants of 23-29 weeks' gestation.DesignCluster randomised controlled trial.Setting and participants114 neonatal intensive care units (which treated 6039 infants of 23-29 weeks gestation born in 2001).Main outcome measuresProcess of care measures: proportion of infants receiving first surfactant in the delivery room, proportion receiving first surfactant more than two hours after birth, and median time from birth to first dose of surfactant. Clinical outcomes: death before discharge home, and pneumothorax.InterventionMultifaceted collaborative quality improvement advice including audit and feedback, evidence reviews, an interactive training workshop, and ongoing faculty support via conference calls and email.ResultsCompared with those in control hospitals, infants in intervention hospitals were more likely to receive surfactant in the delivery room (adjusted odds ratio 5.38 (95% confidence interval 2.84 to 10.20)), were less likely to receive the first dose more than two hours after birth (adjusted odds ratio 0.35 (0.24 to 0.53)), and received the first dose of surfactant sooner after birth (median of 21 minutes v 78 minutes, P < 0.001). The intervention effect on timing of surfactant was larger for infants born in the participating hospitals than for infants transferred to a participating hospital after birth. There were no significant differences in mortality or pneumothorax.ConclusionA multifaceted intervention including audit and feedback, evidence reviews, quality improvement training, and follow up support changed the behaviour of health professionals and promoted evidence based practice.
| S-EPMC524548 | biostudies-literature
Project description:IntroductionLocal institutional echocardiogram protocols reflect standard measurements as per national guidelines, but adherence to measurements was inconsistent. This inconsistency led to variability in reporting and impacted the use of serial measurements for clinical decision-making. Therefore, we aimed to improve complete adherence to universal and protocol-specific measures for echocardiograms performed for first-time or cardiomyopathy studies from 60% to 90% from July 2019 to February 2020.MethodsWe included all sonographer-performed echocardiograms for first-time or cardiomyopathy protocol studies. We reviewed universal measures and protocol-specific measures for all included studies. We created a scoring system reflecting measurement completion. We used a control chart to measure compliance and established a baseline over 2 months. PDSA cycles over 5 months included interventions such as sonographer education, technical improvements to the measurement toolbar, and group and individual performance feedback.ResultsWe reviewed over 4000 studies-the reporting of complete universal measures improved significantly from a median score of 60% to 93%. Protocol-specific measures for first-time studies also showed significant improvement from 62% to 90% adherence. Cardiomyopathy-specific measures demonstrated 87% adherence at baseline, which improved to 95% but then returned to baseline. Sonographer education and toolbar adjustment prompted special cause variation with further improvement following performance feedback. The universal and first-time protocol measures reached 90% adherence with sustained improvement for over 9 months.ConclusionsWe employed quality improvement methodology to improve complete adherence to echocardiographic protocol measurements, thereby facilitating echocardiographic quality and reporting consistency. We plan to spread these interventions to improve adherence to other protocols.
| S-EPMC8782111 | biostudies-literature
Project description:The nematode worm Caenorhabditis elegans (C. elegans) is a versatile and widely used animal model for in vivo studies of a broad range of human diseases, in particular for understanding their genetic origins and for screening drug candidates. Nevertheless, the challenges associated with the administration of native proteins to C. elegans have limited the range of applications of this animal model in protein-based drug discovery programs. Here, we describe a readily usable protocol for the transduction of native proteins in C. elegans, which is based on the encapsulation of the proteins of interest within cationic lipid vesicles, prior to their administration to worms. This procedure limits the degradation of the proteins in the guts of the animals, and promotes their adsorption into body tissues. To illustrate the efficacy of this approach we apply it to deliver an antibody designed to inhibit α-synuclein aggregation, and show that it can lead to the rescue of the disease phenotype in a C. elegans model of Parkinson's disease. As this transduction protocol is fast and inexpensive, we anticipate that it will be readily applicable to protein-based drug discovery studies that utilize C. elegans as a model organism.
| S-EPMC5678089 | biostudies-literature
Project description:High-quality fat (HQF) contains a higher proportion of stromal vascular fraction, adipose-derived stem cells, and extracellular matrix components, surpassing the effectiveness of the traditional Coleman fat grafting method and improving volumetric filling. However, this high-quality fat strategy inevitably leads to a significant amount of unused fat being wasted. CEFFE, a cell-free extract derived from autologous fat tissue, is enriched with bioactive molecules. In this study, we further process the remaining fat from preparing HQF into CEFFE to promote the survival of transplanted fat. Our study introduces CEFFE, from the remaining fat from preparing HQF, as a promising adjunct to HQF grafting, showcasing notable enhancements in graft survival, adipose tissue integrity, and angiogenesis. The observed positive effects on ADSCs, including augmented stemness and adipogenic differentiation potential, further contribute to the overall improvement in fat graft outcomes. While these findings present a novel strategy for addressing the limitations of traditional fat grafting, additional research and clinical studies are imperative to validate the long-term efficacy, safety, and broader applicability of CEFFE in enhancing fat graft survival and promoting tissue regeneration.
2024-01-16 | GSE253141 | GEO
Project description:DNA vaccination has been extensively studied as a promising strategy for tumor treatment. Despite the efforts, the therapeutic efficacy of DNA vaccines has been limited by their intrinsic poor cellular internalization. Electroporation, which is based on the application of a controlled electric field to enhance DNA penetration into cells, has been the method of choice to produce acceptable levels of gene transfer in vivo. However, this method may cause cell damage or rupture, non-specific targeting, and even degradation of pDNA. Skin irritation, muscle contractions, pain, alterations in skin structure, and irreversible cell damage have been frequently reported. To overcome these limitations, in this work, we use a microfluidic platform to generate DNA-loaded lipid nanoparticles (LNPs) which are then characterized by a combination of dynamic light scattering (DLS), synchrotron small-angle X-ray scattering (SAXS), and transmission electron microscopy (TEM). Despite the clinical successes obtained by LNPs for mRNA and siRNA delivery, little is known about LNPs encapsulating bulkier DNA molecules, the clinical application of which remains challenging. For in vitro screening, LNPs were administered to human embryonic kidney 293 (HEK-293) and Chinese hamster ovary (CHO) cell lines and ranked for their transfection efficiency (TE) and cytotoxicity. The LNP formulation exhibiting the highest TE and the lowest cytotoxicity was then tested for the delivery of the DNA vaccine pVAX-hECTM targeting the human neoantigen HER2, an oncoprotein overexpressed in several cancer types. Using fluorescence-activated cell sorting (FACS), immunofluorescence assays and fluorescence confocal microscopy (FCS), we proved that pVAX-hECTM-loaded LNPs produce massive expression of the HER2 antigen on the cell membrane of HEK-293 cells. Our results provide new insights into the structure-activity relationship of DNA-loaded LNPs and pave the way for the access of this gene delivery technology to preclinical studies.
| S-EPMC9416266 | biostudies-literature
Project description:BackgroundDissemination is a critical facet of implementing quality improvement in organizations. As a field, addiction treatment has produced effective interventions but disseminated them slowly and reached only a fraction of people needing treatment. This study investigates four methods of disseminating quality improvement (QI) to addiction treatment programs in the U.S. It is, to our knowledge, the largest study of organizational change ever conducted in healthcare. The trial seeks to determine the most cost-effective method of disseminating quality improvement in addiction treatment.MethodsThe study is evaluating the costs and effectiveness of different QI approaches by randomizing 201 addiction-treatment programs to four interventions. Each intervention used a web-based learning kit plus monthly phone calls, coaching, face-to-face meetings, or the combination of all three. Effectiveness is defined as reducing waiting time (days between first contact and treatment), increasing program admissions, and increasing continuation in treatment. Opportunity costs will be estimated for the resources associated with providing the services.OutcomesThe study has three primary outcomes: waiting time, annual program admissions, and continuation in treatment. Secondary outcomes include: voluntary employee turnover, treatment completion, and operating margin. We are also seeking to understand the role of mediators, moderators, and other factors related to an organization's success in making changes.AnalysisWe are fitting a mixed-effect regression model to each program's average monthly waiting time and continuation rates (based on aggregated client records), including terms to isolate state and intervention effects. Admissions to treatment are aggregated to a yearly level to compensate for seasonality. We will order the interventions by cost to compare them pair-wise to the lowest cost intervention (monthly phone calls). All randomized sites with outcome data will be included in the analysis, following the intent-to-treat principle. Organizational covariates in the analysis include program size, management score, and state.DiscussionThe study offers seven recommendations for conducting a large-scale cluster-randomized trial: provide valuable services, have aims that are clear and important, seek powerful allies, understand the recruiting challenge, cultivate commitment, address turnover, and encourage rigor and flexibility.Trial registrationClinicalTrials. govNCT00934141.
| S-EPMC3108336 | biostudies-literature
Project description:OBJECTIVE:To assess whether a multiphase, departmental quality improvement effort decreases opioid prescribing and increases multimodal analgesic use after cesarean delivery. METHODS:This is a prospective quality improvement study. In phase 1 of the protocol, discharge providers implemented counseling regarding expectations for pain, typical need for opioids, and importance of multimodal nonopioid analgesic use and used shared decision-making to determine the number of opioids prescribed. Patients could select up to a maximum of 30 tablets of 5 mg oxycodone (or equivalent opioid), lower than the previous routine discharge prescription of 40 opioid tablets. The primary outcome was the mean (SD) number of opioid tablets prescribed on discharge with secondary outcomes including opioid refill rate within 30 days of discharge and rates of nonopioid analgesic prescriptions on discharge. In phase 2, using these results, we adjusted the protocol's maximum opioid prescription to 25 opioid tablets, but no other aspects of the protocol were changed. All data were analyzed with t test and ? analyses. RESULTS:Data from 624 women who underwent cesarean deliveries were analyzed. Opioids, most commonly oxycodone, were prescribed after 95% of all cesarean deliveries. The mean (SD) number of opioid tablets prescribed decreased from 33.2 (9.3) to 26.5 (6.7; P<.01) with the implementation of phase 1 having no effect on the opioid refill rate, 8.9% vs 8.1% (P=.79). These results allowed adjustment of the maximum recommended prescription to 25 opioid tablets, introducing phase 2 of the study, during which the mean (SD) number of opioid tablets prescribed further decreased from 24.9 (7.5) to 21.5 (6.3; P<.01) with no effect on the opioid refill rate, 6.3% vs 5.1% (P=.72). Overall, this represents a 35% decrease in opioid prescribing (P<.01). Rates of ibuprofen prescribing were 98% or higher throughout the study, but rates of acetaminophen prescribing increased from 32.6% before phase 1 to 92.0% after phase 2 (P<.001). CONCLUSION:Implementation of a multiphase quality improvement protocol to decrease opioid prescribing, combined with iterative review of discharge data, resulted in a significant decrease in the number of opioid tablets prescribed after cesarean delivery.
| S-EPMC6105442 | biostudies-literature
Project description:BACKGROUND:Improvement work can be used in preschools to enrich outdoor environment for children's better health. Effective improvement work can facilitate the necessary changes, but little is known about professionals' experiences of participation in improvement interventions. The aim was to evaluate how preschool staff experience quality improvement work, using the Breakthrough Series Collaborative improvement programme, to enhance outdoor environments. METHODS:An improvement intervention using a breakthrough collaborative was performed at 9 preschools in Sweden and examined with a longitudinal mixed method design. Staff completed questionnaires on 4 occasions (n=45 participants) and interviews took place after the intervention (n=16 participants). RESULTS:The intervention was successful in the sense that the staff were content with the learning seminars, and they had triggered physical changes in the outdoor environment. They integrated the quality improvement work with their ordinary work and increasingly involved the children. The staff tested improvement tools but did not find them entirely appropriate for their work, because they preferred existing methods for reflection. CONCLUSIONS:The challenges in quality improvement work seem to be similar across contexts. Using the Breakthrough Series Collaborative in a public health intervention is promising but needs to be integrated with preunderstandings, current reflections and quality tools and models.
| S-EPMC7445333 | biostudies-literature
Project description:Platelets are natural delivery vehicles within the blood, carrying and releasing their contents at sites of vasculature damage. Investigating the biology of platelets, and modifying them for new therapeutic uses, is limited by a lack of methods for efficiently transfecting these cells. The ability of four different classes of lipid nanoparticles (LNPs) to deliver mRNA to platelets was compared using confocal microscopy, flow cytometry and quantitative PCR. The amount of mRNA delivered, mechanism of uptake, and extent of platelet activation depended on the LNP formulation and platelet storage conditions. Cationic LNPs (cLNPs) delivered mRNA to the largest percentage of platelets but induced platelet activation. Ionizable cationic LNPs (icLNPs) delivered mRNA to fewer platelets and did not induce activation. Furthermore, mRNA delivered using icLNPs and cLNPs was stable in resting platelets and was released in platelet microparticles under specific conditions. The results demonstrate that mRNA can be delivered to platelets using cLNPs and icLNPs without impairing platelet aggregation or spreading. Optimizing the LNP formulations used here may lead to a transfection agent for platelets that allows for de novo synthesis of exogenous proteins in the future.
| S-EPMC6345896 | biostudies-other