Repeat prenatal corticosteroid prior to preterm birth: a systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: assessing the effects using the best level of evidence) - study protocol

Background The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol. Methods/Design The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia). Discussion Data analyses are expected to commence in 2011 with results publicly available in 2012

Effects of repeat prenatal corticosteroids given to women at risk of preterm birth: An individual participant data meta-analysis

BACKGROUND:Infants born preterm compared with infants born at term are at an increased risk of dying and of serious morbidities in early life, and those who survive have higher rates of neurological impairments. It remains unclear whether exposure to repeat courses of prenatal corticosteroids can reduce these risks. This individual participant data (IPD) meta-analysis (MA) assessed whether repeat prenatal corticosteroid treatment given to women at ongoing risk of preterm birth in order to benefit their infants is modified by participant or treatment factors. METHODS AND FINDINGS:Trials were eligible for inclusion if they randomised women considered at risk of preterm birth who had already received an initial, single course of prenatal corticosteroid seven or more days previously and in which corticosteroids were compared with either placebo or no placebo. The primary outcomes for the infants were serious outcome, use of respiratory support, and birth weight z-scores; for the children, they were death or any neurosensory disability; and for the women, maternal sepsis. Studies were identified using the Cochrane Pregnancy and Childbirth search strategy. Date of last search was 20 January 2015. IPD were sought from investigators with eligible trials. Risk of bias was assessed using criteria from the Cochrane Collaboration. IPD were analysed using a one-stage approach. Eleven trials, conducted between 2002 and 2010, were identified as eligible, with five trials being from the United States, two from Canada, and one each from Australia and New Zealand, Finland, India, and the United Kingdom. All 11 trials were included, with 4,857 women and 5,915 infants contributing data. The mean gestational age at trial entry for the trials was between 27.4 weeks and 30.2 weeks. There was no significant difference in the proportion of infants with a serious outcome (relative risk [RR] 0.92, 95% confidence interval [CI] 0.82 to 1.04, 5,893 infants, 11 trials, p = 0.33 for heterogeneity). There was a reduction in the use of respiratory support in infants exposed to repeat prenatal corticosteroids compared with infants not exposed (RR 0.91, 95% CI 0.85 to 0.97, 5,791 infants, 10 trials, p = 0.64 for heterogeneity). The number needed to treat (NNT) to benefit was 21 (95% CI 14 to 41) women/fetus to prevent one infant from needing respiratory support. Birth weight z-scores were lower in the repeat corticosteroid group (mean difference -0.12, 95%CI -0.18 to -0.06, 5,902 infants, 11 trials, p = 0.80 for heterogeneity). No statistically significant differences were seen for any of the primary outcomes for the child (death or any neurosensory disability) or for the woman (maternal sepsis). The treatment effect varied little by reason the woman was considered to be at risk of preterm birth, the number of fetuses in utero, the gestational age when first trial treatment course was given, or the time prior to birth that the last dose was given. Infants exposed to between 2-5 courses of repeat corticosteroids showed a reduction in both serious outcome and the use of respiratory support compared with infants exposed to only a single repeat course. However, increasing numbers of repeat courses of corticosteroids were associated with larger reductions in birth z-scores for weight, length, and head circumference. Not all trials could provide data for all of the prespecified subgroups, so this limited the power to detect differences because event rates are low for some important maternal, infant, and childhood outcomes. CONCLUSIONS:In this study, we found that repeat prenatal corticosteroids given to women at ongoing risk of preterm birth after an initial course reduced the likelihood of their infant needing respiratory support after birth and led to neonatal benefits. Body size measures at birth were lower in infants exposed to repeat prenatal corticosteroids. Our findings suggest that to provide clinical benefit with the least effect on growth, the number of repeat treatment courses should be limited to a maximum of three and the total dose to between 24 mg and 48 mg.Caroline A. Crowther, Philippa F. Middleton, Merryn Voysey, Lisa Askie, Sasha Zhang, Tanya K. Martlo

Repeat prenatal corticosteroid prior to preterm birth: a systematic review and individual participant data meta-analysis for the PRECISE study group

The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol. The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia). Data analyses are expected to commence in 2011 with results publicly available in 2012

Multiple vs. single courses of antenatal corticosteroids for preterm birth

grantor: University of TorontoA single course of antenatal corticosteroids (ACS) decreases the risk of death, respiratory distress syndrome (RDS) and possibly intraventricular hemorrhage in babies at risk of preterm delivery. The effects on RDS are most significant if babies are born between 24 hours and 7-10 following treatment. As a result, many centers repeat courses of ACS every 7-10 days. Systematic reviews of studies in humans and animals show some benefits and risks for multiple courses of ACS. I designed multi-center randomized controlled trial to assess the effects of multiple vs. single courses of ACS on neonatal outcomes. A pilot study of this trial suggests a multi-center trial is feasible, but care should be given to the strategy for recruiting pregnant women.M.Sc

Vitamin D during Pregnancy

Vitamin D plays an important role in promoting healthy pregnancy and fetal development. There is a lack of knowledge on (1) the effect of vitamin D deficiency/ insufficiency on pregnancy and neonatal outcomes, (2) the association between maternal plasma vitamin D concentration and dietary intake, and (3) the prevalence of vitamin D deficiency/ insufficiency during pregnancy and the contribution of vitamin D metabolites to estimate vitamin D. This dissertation attempts to address these knowledge gaps about vitamin D during pregnancy. In a systematic review and meta-analysis of observational studies, low maternal 25(OH)D concentrations were found to be associated with higher risks of gestational diabetes (pooled OR 1.49, 95% CI: 1.18 to 1.89), preeclampsia (pooled OR 1.79, 95% CI: 1.25 to 2.58), small for gestational age (SGA) (pooled OR 1.85, 95% CI: 1.52 to 2.26) and lower birth weight (weighted mean difference: -130.92 g (95% CI: -186.69 to -75.14). However, that quality of individual studies was not always optimal due to inconsistent reporting on confounding factors. The two studies in this work involved pregnant women from a large Alberta cohort study to measure vitamin D. 3-epi-25(OH)D3 was found in all of the pregnant women’s blood in mid-pregnancy, at the time of delivery and in cord blood. When the 3-epimer was included in the estimation of status, the prevalence of vitamin D <75 nmol/L was significantly lower (P<0.005). A significant relationship between maternal reported dietary vitamin D intake and plasma 25(OH)D and 3-epi-25(OH)D3 concentration were identified. Consuming the Recommended Dietary Allowance (RDA) (600 IU/ day) was found to be insufficient to achieve vitamin D <75 nmol/L in half of participants. This research highlighted the potentially important association between maternal vitamin D status and pregnancy health and the variability that can arise in study results when different measures of vitamin D status are used. In addition, it extends the literature suggesting that current RDA may not be adequate to ensure that Canadian pregnant women achieving vitamin D status. Furthermore, this research showed that the method employed to measure vitamin D in pregnant women and cord blood can influence the estimates of status

Both Mother and Infant Require a Vitamin D Supplement to Ensure That Infants' Vitamin D Status Meets Current Guidelines

We examined the association between maternal vitamin D intake during breastfeeding with their infants' vitamin D status in infants who did or did not receive vitamin D supplements to determine whether infant supplementation was sufficient. Using plasma from a subset of breastfed infants in the APrON (Alberta Pregnant Outcomes and Nutrition) cohort, vitamin D status was measured by liquid chromatography-tandem mass spectrometry. Maternal and infants' dietary data were obtained from APrON's dietary questionnaires. The median maternal vitamin D intake was 665 International Units (IU)/day, while 25% reported intakes below the recommended 400 IU/day. Of the 224 infants in the cohort, 72% were exclusively breastfed, and 90% were receiving vitamin D supplements. Infants' median 25(OH)D was 96.0 nmol/L (interquartile ranges (IQR) 77.6-116.2), and 25% had 25(OH)D < 75 nmol/L. An adjusted linear regression model showed that, with a 100 IU increase in maternal vitamin D intake, infants' 25(OH)D increased by 0.9 nmol/L controlling for race, season, mid-pregnancy maternal 25(OH)D, birthweight, and whether the infant received daily vitamin D supplement (β = 0.008, 95% confidence interval (CI) 0.002, 0.13). These results suggest that, to ensure infant optimal vitamin D status, not only do infants require a supplement, but women also need to meet current recommended vitamin D intake during breastfeeding

Relationship Between Visual Constructive Abilities and Activity of Daily Living in Home Dwelling Elderly Population

Objectives:&nbsp;Increasing life expectancy and decreasing birthrates have significantly contributed to an increased aging population throughout the world. This sudden change is a global phenomenon often resulting in biological changes that may have various consequences, such as reduced life power and coping skills in the elderly population. Cognitive deficits are one of the most severe impairments in the elderly people. Deficits in cognitive abilities, especially visual constructive skills, can have a considerable impact on the independency of the daily living skills of the elderly people. Self-care by individuals to maintain their life and wellbeing is a key element for their independency. The activity of daily living (ADL) can support personal life independency, and is considered as a morbidity index. In the present cross-sectional study, we assessed the visual abilities and ADL in older subjects to determine whether cognitive impairment is associated with changes in self-care behavior. Methods & Materials:&nbsp;This study employed random sampling technique to select and recruit forty seven individuals aged between 60 to 80 years from Jahandidegan club in Shiraz, Iran. They were evaluated through &quot;visual constructive ability&quot; sub-scale from Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) battery and &quot;Katz Index&quot;, which were used to assess their associated skill and ADL, respectively. Data was collected through observation and interviews. Data analysis was performed through Pearson's correlation test using SPSS. Results: The mean age of the participants (9 women and 38 men) was 69.94&plusmn;4.66 years. Lower scores in cognitive domains predicted functional decline in some scales. There was a significant correlation&nbsp;between visual constructive ability and eating; however, no significant correlation was found between this sub-scale with bathing, moving, toileting, and bowel control. Conclusion:&nbsp;In summary, a significant correlation was noted between visual constructive abilities and dressing and eating activities. A weak correlation was observed between cognition and personal independency that may result from the less demanding cognitive processing tasks

Thinking and Enacting the Patient Medical Home Under Pandemic Conditions: A Qualitative Study From Primary Care in Alberta, Canada

Background: The COVID-19 (C19) pandemic shocked primary care systems around the world. Those systems responded by supporting patients in the community, and acute care facilities in crisis. In Canada, the Patient Medical Home (PMH) is a widely adopted care model that aims to operationalize the tenets and principles of Primary Health Care (PHC) as developed since the Alma-Ata Declaration. This paper describes how personnel working in and with Primary Care Networks (PCNs) in Alberta, Canada deployed the PMH model and its underlying PHC principles to frame and respond to the C19 shock. Methods: Using purposive and snowball sampling techniques, we interviewed 57 participants who worked in public health and primary care, including community-based family physicians. We used interpretive description to analyze the interviews. Results: PCN staff and physicians described how the PMH model was foundational to normal operations, and how C19 responses were framed by the patient-centric, team-delivered, and continuous care principles the model shares with PHC. Specifically, participants described ensuring access to care, addressing the social determinants of health, being patient centered, and redeploying and expanding PHC teams to accomplish these goals. Discussion: Delivering PHC through the PMH allowed physicians and allied health staff to deliver patient-centered, team-based, holistic bio-medical services to Albertans. In tailoring services to meet the specific social and health needs of the populations served by each PCN, healthcare providers were able to ensure relevant support remained available and accessible

Evaluating effectiveness of small group literacy instruction for Undergraduate Medical Education students using a pre-post survey study design

The purpose of our study was to determine if librarian-led small group information literacy instruction, closely integrated with course content and faculty participation, but without a hands on component, was an effective means to convey evidence based information literacy skills including clinical question formation, resource selection and online searching confidence. Five 15 minute evidence based information literacy sessions were delivered by three librarians to 12 practicing physician-led small groups of 15 students. Students were asked to complete an online survey before and after the lecture and seminar series. Data analysis was through simple descriptive statistics, reporting proportions for question responses. Instruction in a small group environment without a mandatory hands on component had a positive impact on student’s evidence based information literacy skills. Students were more likely to consult a librarian, and had increased confidence in their abilities to search and find relevant information.Ye