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"Carl, Lynette L"
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Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol
Background
Preterm birth contributes to 0.5 million deliveries in the United States (one of eight pregnancies) and poses a huge burden on public health with costs in the billions. Of particular concern is that the rate of earliest preterm birth (<34 weeks) (ePTB), which has decreased little since 1990 and has the greatest impact on the overall infant mortality, resulting in the greatest cost to society. Docosahexaenoic acid (DHA) supplementation provides a potential high yield, low risk strategy to reduce early preterm delivery in the US by up to 75%. We propose a Phase III Clinical Trial (randomized to low or high dose DHA, double-blinded) to examine the efficacy and safety of high dose DHA supplementation to reduce ePTB. We also plan for a secondary pregnancy efficacy analysis to determine if there is a subset of pregnancies most likely to benefit from DHA supplementation.
Methods
Between 900 and 1200 pregnant women who are ≥ 18 years old and between 12 and 20 weeks gestation will be recruited from three trial experienced academic medical institutions. Participants will be randomly assigned to two daily capsules of algal oil (totaling 800 mg DHA) or soybean and corn oil (0 mg DHA). Both groups will receive a commercially available prenatal supplement containing 200 mg DHA. Therefore, the experimental group will receive 1000 mg DHA/d and the control group 200 mg DHA/d. We will then employ a novel Bayesian response adaptive randomization design that assigns more subjects to the “winning” group and potentially allows for substantially smaller sample size while providing a stronger conclusion regarding the most effective group. The study has an overall Type I error rate of 5% and a power of 90%. Participants are followed throughout pregnancy and delivery for safety and delivery outcomes.
Discussion
We hypothesize that DHA will decrease the frequency of ePTB <34 weeks. Reducing ePTB is clinically important as these earliest preterm deliveries carry the highest risk of neonatal morbidity, as well as contribute significant stress for families and post a large societal burden.
Trial registration
This trial was registered with ClinicalTrials.gov (identifier:
NCT02626299
) on December 8, 2015. Additional summary details may be found in Table
1.
Journal Article
Prevalence of sexual dimorphism in mammalian phenotypic traits
The role of sex in biomedical studies has often been overlooked, despite evidence of sexually dimorphic effects in some biological studies. Here, we used high-throughput phenotype data from 14,250 wildtype and 40,192 mutant mice (representing 2,186 knockout lines), analysed for up to 234 traits, and found a large proportion of mammalian traits both in wildtype and mutants are influenced by sex. This result has implications for interpreting disease phenotypes in animal models and humans.
Systemic dissection of sexually dimorphic phenotypes in mice is lacking. Here, Karp and the International Mouse Phenotype Consortium show that approximately 10% of qualitative traits and 56% of quantitative traits in mice as measured in laboratory setting are sexually dimorphic.
Journal Article
Longitudinal Outcome of Programmatic Assessment of International Medical Graduates
Australia depends on international medical graduates (IMGs) to meet workforce shortages. The current standard assessment for IMGs is by clinical examination in observed structured clinical encounter (OSCE) format lasting 200 minutes. There are concerns about adequateness of this assessment as it does not test the qualities required to practice in a new country. We introduced a programmatic performance-based assessment for IMGs to prepare them to meet these challenges. The workplace-based assessment (WBA) program involves six-month longitudinal programmatic assessments comprising of 12 mini-clinical evaluation exercises (Mini-CEX), five case-based discussions (CBD), two in-training assessments (ITAs) and two sets of multisource feedback (MSF) assessments. We assessed 254 IMGs since 2010. We conducted a survey to evaluate the satisfaction with the program and the outcomes of these doctors.
We surveyed 254 candidates from 2010 to 2020. The survey used \"SelectSurvey\" tool with 12 questions and free-text comments. All candidates were sent the survey link to their last registered mobile phone using \"Telstra Instant Messaging Service\". We analysed the data using Microsoft \"Excel\".
We received 153 (60%) responses. Amongst them, 141 (92%) candidates did not require further supervised practice for general registration and 129 (84%) candidates hold general/specialist registration. The candidates found the program useful and felt well supported. They appreciated real patient encounters. The feedback with positive critiquing was helpful in improving their clinical practice. The negative themes were program costs and frustration with the length of the program.
Upon completion of the WBA program and obtaining the AMC certificate, most of the doctors were able to gain general registration. Seventy-eight (50%) candidates chose to continue their careers within the local area with 124 (80%) of them within the state. Our survey shows a comprehensive assessment program with immediate constructive feedback produces competent doctors to fill the medical workforce shortages.
Journal Article
Explaining Extreme Events of 2020 from a Climate Perspective
Editors note: For easy download the posted pdf of the Explaining Extreme Events of 2020 is a very low-resolution file. A high-resolution copy of the report is available by clicking here . Please be patient as it may take a few minutes for the high-resolution file to download.
Journal Article
Postexposure Immunoprophylaxis of Primary Isolates by an Antibody to HIV Receptor Complex
mAb B4 is a monoclonal antibody directed against HIV receptor complex. The antibody had broad neutralizing activity against HIV and provided postexposure prophylaxis to hu-peripheral blood leukocyte (PBL)-severe combined immunodeficient mice and chimpanzees. B4 recognized a complex receptor site for HIV on the T cell surface that includes CD4 and also may be influenced by interaction with HIV coreceptors. mAb B4 preferentially neutralized primary HIV-1 isolates compared with T cell line-adapted strains, including syncytium-inducing and non-syncytium-inducing phenotypes, representatives from HIV-1 subtypes A-G, as well as HIV-2, simian immunodeficiency virus, and chimeric simian/human immunodeficiency virus (SHIV). Neutralization was demonstrated in both pre- and postinfection models. The administration of mAb B4 after infectious challenge totally interrupted the infection of hu-PBL-severe combined immunodeficient mice by PBL-grown HIV-1 and the infection of chimpanzees by chimp-adapted HIV-1. This mode of protection suggested that the anti-HIV receptor antibody is efficacious for prophylaxis after exposure to HIV and for prevention of maternal transmission and may be an effective antiretroviral agent for treatment.
Journal Article
Critical Perspectives on International Education
To respond to these emerging learning and living contexts of our world, this book brings together some of the most active and established scholars in the field. As such, the book represents important epistemic interventions that analyze and critique the institutional, socio-economic, linguistic and pedagogical platforms of international education.
eBook
Correlations between rapid germination and seedling vigor in the common zucchini (Cucurbita pepo)
During the spring of 1985, we compared, through a series of experiments, the germination and growth of zucchini seeds. Our analyses of these data reveal that rapid seedling emergence is significantly negatively correlated with a variety of later growth measurements even when seed size is controlled. These findings have important implications for plant scientists who must rapidly assess offspring performance with limited greenhouse or experimental garden space.
Journal Article