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The COVID-19 pandemic accelerated the development of decentralized clinical trials (DCT). DCT’s are an important and pragmatic method for assessing health outcomes yet comprise only a minority of clinical trials, and few published methodologies exist. In this report, we detail the operational components of COVID-OUT, a decentralized, multicenter, quadruple-blinded, randomized trial that rapidly delivered study drugs nation-wide. The trial examined three medications (metformin, ivermectin, and fluvoxamine) as outpatient treatment of SARS-CoV-2 for their effectiveness in preventing severe or long COVID-19. Decentralized strategies included HIPAA-compliant electronic screening and consenting, prepacking investigational product to accelerate delivery after randomization, and remotely confirming participant-reported outcomes. Of the 1417 individuals with the intention-to-treat sample, the remote nature of the study caused an additional 94 participants to not take any doses of study drug. Therefore, 1323 participants were in the modified intention-to-treat sample, which was the a priori primary study sample. Only 1.4% of participants were lost to follow-up. Decentralized strategies facilitated the successful completion of the COVID-OUT trial without any in-person contact by expediting intervention delivery, expanding trial access geographically, limiting contagion exposure, and making it easy for participants to complete follow-up visits. Remotely completed consent and follow-up facilitated enrollment.
Government policy guidance in Victoria, Australia, encourages schools to provide affordable, healthy foods in canteens. This study analysed the healthiness and price of items available in canteens in Victorian primary schools and associations with school characteristics.
Dietitians classified menu items (main, snack and beverage) using the red, amber and green traffic light system defined in the Victorian government’s School Canteens and Other School Food Services Policy. This system also included a black category for confectionary and high sugar content soft drinks which should not be supplied. Descriptive statistics and regressions were used to analyse differences in the healthiness and price of main meals, snacks and beverages offered, according to school remoteness, sector (government and Catholic/independent) size, and socio-economic position.
State of Victoria, Australia
A convenience sample of canteen menus drawn from three previous obesity prevention studies in forty-eight primary schools between 2016 and 2019.
On average, school canteen menus were 21 % ‘green’ (most healthy – everyday), 53 % ‘amber’ (select carefully), 25 % ‘red’ (occasional) and 2 % ‘black’ (banned) items, demonstrating low adherence with government guidelines. ‘Black’ items were more common in schools in regional population centres. ‘Red’ main meal items were cheaper than ‘green’% (mean difference –$0·48 (95 % CI –0·85, –0·10)) and ‘amber’ –$0·91 (–1·27, –0·57)) main meal items. In about 50 % of schools, the mean price of ‘red’ main meal, beverages and snack items were cheaper than ‘green’ items, or no ‘green’ alternative items were offered.
In this sample of Victorian canteen menus, there was no evidence of associations of healthiness and pricing by school characteristics except for regional centres having the highest proportion of ‘black’ (banned) items compared with all other remoteness categories examined. There was low adherence with state canteen menu guidelines. Many schools offered a high proportion of ‘red’ food options and ‘black’ (banned) options, particularly in regional centres. Unhealthier options were cheaper than healthy options. More needs to be done to bring Victorian primary school canteen menus in line with guidelines.
The cornerstone of obesity treatment is behavioural weight management, resulting in significant improvements in cardio-metabolic and psychosocial health. However, there is ongoing concern that dietary interventions used for weight management may precipitate the development of eating disorders. Systematic reviews demonstrate that, while for most participants medically supervised obesity treatment improves risk scores related to eating disorders, a subset of people who undergo obesity treatment may have poor outcomes for eating disorders. This review summarises the background and rationale for the formation of the Eating Disorders In weight-related Therapy (EDIT) Collaboration. The EDIT Collaboration will explore the complex risk factor interactions that precede changes to eating disorder risk following weight management. In this review, we also outline the programme of work and design of studies for the EDIT Collaboration, including expected knowledge gains. The EDIT studies explore risk factors and the interactions between them using individual-level data from international weight management trials. Combining all available data on eating disorder risk from weight management trials will allow sufficient sample size to interrogate our hypothesis: that individuals undertaking weight management interventions will vary in their eating disorder risk profile, on the basis of personal characteristics and intervention strategies available to them. The collaboration includes the integration of health consumers in project development and translation. An important knowledge gain from this project is a comprehensive understanding of the impact of weight management interventions on eating disorder risk.
Our dominant food system is a primary driver of worsening human and planetary health. Held in March 2022, the Public Health Association of Australia’s Food Futures Conference was an opportunity for people working across the food system to connect and advocate for a comprehensive, intersectoral, whole-of-society food and nutrition policy in Australia to attenuate these issues. Conference themes included food systems for local and global good; ecological nutrition; social mobilisation for planetary and public good; food sovereignty and food equity. Students and young professionals are integral in transforming food systems, yet they are under-represented in the academic workforce, across publishing, scientific societies and conference plenaries. A satellite event was held to platform initiatives from early career researchers (ECR) in areas integral for improving planetary and public good. The research topics discussed in this commentary reflect sub-themes of the conference under investigation by ECR: food systems governance and regulation; local food policies; commercial determinants of health; sustainable healthy diets; and food equity and sovereignty.
Methicillin-resistant Staphylococcus aureus (MRSA) is an important pathogen in neonatal intensive care units (NICU) that confers significant morbidity and mortality.
Improving our understanding of MRSA transmission dynamics, especially among high-risk patients, is an infection prevention priority.
We investigated a cluster of clinical MRSA cases in the NICU using a combination of epidemiologic review and whole-genome sequencing (WGS) of isolates from clinical and surveillance cultures obtained from patients and healthcare personnel (HCP).
Phylogenetic analysis identified 2 genetically distinct phylogenetic clades and revealed multiple silent-transmission events between HCP and infants. The predominant outbreak strain harbored multiple virulence factors. Epidemiologic investigation and genomic analysis identified a HCP colonized with the dominant MRSA outbreak strain who cared for most NICU patients who were infected or colonized with the same strain, including 1 NICU patient with severe infection 7 months before the described outbreak. These results guided implementation of infection prevention interventions that prevented further transmission events.
Silent transmission of MRSA between HCP and NICU patients likely contributed to a NICU outbreak involving a virulent MRSA strain. WGS enabled data-driven decision making to inform implementation of infection control policies that mitigated the outbreak. Prospective WGS coupled with epidemiologic analysis can be used to detect transmission events and prompt early implementation of control strategies.
We compared the rates of hospital-onset secondary bacterial infections in patients with coronavirus disease 2019 (COVID-19) with rates in patients with influenza and controls, and we investigated reports of increased incidence of Enterococcus infections in patients with COVID-19.
Retrospective cohort study.
An academic quaternary-care hospital in San Francisco, California.
Patients admitted between October 1, 2019, and October 1, 2020, with a positive SARS-CoV-2 PCR (N = 314) or influenza PCR (N = 82) within 2 weeks of admission were compared with inpatients without positive SARS-CoV-2 or influenza tests during the study period (N = 14,332).
National Healthcare Safety Network definitions were used to identify infection-related ventilator-associated complications (IVACs), probable ventilator-associated pneumonia (PVAP), bloodstream infections (BSIs), and catheter-associated urinary tract infections (CAUTIs). A multiple logistic regression model was used to control for likely confounders.
COVID-19 patients had significantly higher rates of IVAC and PVAP compared to controls, with adjusted odds ratios of 4.7 (95% confidence interval [CI], 1.7–13.9) and 10.4 (95 % CI, 2.1–52.1), respectively. COVID-19 patients had higher incidence of BSI due to Enterococcus but not BSI generally, and whole-genome sequencing of Enterococcus isolates demonstrated that nosocomial transmission did not explain the increased rate. Subanalyses of patients admitted to the intensive care unit and patients who required mechanical ventilation revealed similar findings.
COVID-19 is associated with an increased risk of IVAC, PVAP, and Enterococcus BSI compared with hospitalized controls, which is not fully explained by factors such as immunosuppressive treatments and duration of mechanical ventilation. The mechanism underlying increased rates of Enterococcus BSI in COVID-19 patients requires further investigation.
Adequate dietary intake during pregnancy is vital for the health and nutritional status of both mother and fetus. The nutritional status of reproductive age women in Pakistan is poor, with 14 % being underweight (BMI < 18·5) and 42 % experiencing Fe deficiency anaemia. This may stem from beliefs, practices and other barriers influencing dietary intake. This qualitative study seeks to determine which factors impact dietary intake during pregnancy in rural Punjab.
In-depth interviews and focus group discussions were conducted and then analysed using thematic analysis.
Three purposively selected rural districts (Sahiwal, Okara and Pakpatan) with the highest prevalence of maternal and child malnutrition in the province of Punjab, Pakistan
Mothers with children under age two (n 29) and healthcare providers with at least 5 years of experience working in the district (n 12).
We identified a combination of physiological, socio-cultural and structural barriers that inhibited healthful dietary intake during pregnancy. The primary physiological barriers to optimal dietary intake and dietary practices included food aversions and food cravings. Food classification, fear of a difficult childbirth, fear of high blood pressure and household food politics were the principal socio-cultural barriers. Additionally, two structural barriers, inadequate antenatal counseling and a lack of affordable food options, were identified.
Our study demonstrates that complex barriers prevent pregnant women in the Punjab area from consuming adequate dietary intake and that antenatal health education programmes and structural interventions are needed to support healthful dietary practices during this critical period.
Emergency Medical Services (EMS) systems have developed protocols for prehospital activation of the cardiac catheterization laboratory for patients with suspected ST-elevation myocardial infarction (STEMI) to decrease first-medical-contact-to-balloon time (FMC2B). The rate of “false positive” prehospital activations is high. In order to decrease this rate and expedite care for patients with true STEMI, the American Heart Association (AHA; Dallas, Texas USA) developed the Mission Lifeline PreAct STEMI algorithm, which was implemented in Los Angeles County (LAC; California USA) in 2015. The hypothesis of this study was that implementation of the PreAct algorithm would increase the positive predictive value (PPV) of prehospital activation.
This is an observational pre-/post-study of the effect of the implementation of the PreAct algorithm for patients with suspected STEMI transported to one of five STEMI Receiving Centers (SRCs) within the LAC Regional System. The primary outcome was the PPV of cardiac catheterization laboratory activation for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). The secondary outcome was FMC2B.
A total of 1,877 patients were analyzed for the primary outcome in the pre-intervention period and 405 patients in the post-intervention period. There was an overall decrease in cardiac catheterization laboratory activations, from 67% in the pre-intervention period to 49% in the post-intervention period (95% CI for the difference, -14% to -22%). The overall rate of cardiac catheterization declined in post-intervention period as compared the pre-intervention period, from 34% to 30% (95% CI, for the difference -7.6% to 0.4%), but actually increased for subjects who had activation (48% versus 58%; 95% CI, 4.6%-15.0%). Implementation of the PreAct algorithm was associated with an increase in the PPV of activation for PCI or CABG from 37.9% to 48.6%. The overall odds ratio (OR) associated with the intervention was 1.4 (95% CI, 1.1-1.8). The effect of the intervention was to decrease variability between medical centers. There was no associated change in average FMC2B.
The implementation of the PreAct algorithm in the LAC EMS system was associated with an overall increase in the PPV of cardiac catheterization laboratory activation.
Whether maternal obesity and gestational weight gain (GWG) are associated with early-childhood development in low-income, urban, minority populations, and whether effects differ by child sex remain unknown. This study examined the impact of prepregnancy BMI and GWG on early childhood neurodevelopment in the Columbia Center for Children’s Environmental Health Mothers and Newborns study. Maternal prepregnancy weight was obtained by self-report, and GWG was assessed from participant medical charts. At child age 3 years, the Psychomotor Development Index (PDI) and Mental Development Index (MDI) of the Bayley Scales of Infant Intelligence were completed. Sex-stratified linear regression models assessed associations between prepregnancy BMI and pregnancy weight gain z-scores with child PDI and MDI scores, adjusting for covariates. Of 382 women, 48.2% were normal weight before pregnancy, 24.1% overweight, 23.0% obese, and 4.7% underweight. At 3 years, mean scores on the PDI and MDI were higher among girls compared to boys (PDI: 102.3 vs. 97.2, P = 0.0002; MDI: 92.8 vs. 88.3, P = 0.0001). In covariate-adjusted models, maternal obesity was markedly associated with lower PDI scores in boys [b = −7.81, 95% CI: (−13.08, −2.55), P = 0.004], but not girls. Maternal BMI was not associated with MDI in girls or boys, and GWG was not associated with PDI or MDI among either sex (all-P > 0.05). We found that prepregnancy obesity was associated with lower PDI scores at 3 years in boys, but not girls. The mechanisms underlying this sex-specific association remain unclear, but due to elevated obesity exposure in urban populations, further investigation is warranted.
Field identification of ST-elevation myocardial infarction (STEMI) and advanced hospital notification decreases first-medical-contact-to-balloon (FMC2B) time. A recent study in this system found that electrocardiogram (ECG) transmission following a STEMI alert was frequently unsuccessful.
Instituting weekly test ECG transmissions from paramedic units to the hospital would increase successful transmission of ECGs and decrease FMC2B and door-to-balloon (D2B) times.
This was a natural experiment of consecutive patients with field-identified STEMI transported to a single percutaneous coronary intervention (PCI)-capable hospital in a regional STEMI system before and after implementation of scheduled test ECG transmissions. In November 2014, paramedic units began weekly test transmissions. The mobile intensive care nurse (MICN) confirmed the transmission, or if not received, contacted the paramedic unit and the department’s nurse educator to identify and resolve the problem. Per system-wide protocol, paramedics transmit all ECGs with interpretation of STEMI. Receiving hospitals submit patient data to a single registry as part of ongoing system quality improvement. The frequency of successful ECG transmission and time to intervention (FMC2B and D2B times) in the 18 months following implementation was compared to the 10 months prior. Post-implementation, the time the ECG transmission was received was also collected to determine the transmission gap time (time from ECG acquisition to ECG transmission received) and the advanced notification time (time from ECG transmission received to patient arrival).
There were 388 patients with field ECG interpretations of STEMI, 131 pre-intervention and 257 post-intervention. The frequency of successful transmission post-intervention was 73% compared to 64% prior; risk difference (RD)=9%; 95% CI, 1-18%. In the post-intervention period, the median FMC2B time was 79 minutes (inter-quartile range [IQR]=68-102) versus 86 minutes (IQR=71-108) pre-intervention (P=.3) and the median D2B time was 59 minutes (IQR=44-74) versus 60 minutes (IQR=53-88) pre-intervention (P=.2). The median transmission gap was three minutes (IQR=1-8) and median advanced notification time was 16 minutes (IQR=10-25).
Implementation of weekly test ECG transmissions was associated with improvement in successful real-time transmissions from field to hospital, which provided a median advanced notification time of 16 minutes, but no decrease in FMC2B or D2B times.
The government publishes 3 different public report surgical site infection (SSI) metrics, all called standardized infection ratios (SIRs), that impact perceived hospital quality. We conducted a non-random cross-sectional observational pilot study of 20 California hospitals that voluntarily submitted colon surgery and SSI data. Discordant SIR values, leading to contradictory conclusions, occurred in 35% of these hospitals.
A case-control study was conducted to determine risk factors for hospital-onset Clostridium difficile infection among patients admitted to 2 surgical units. Ertapenem prophylaxis was significantly associated with C. difficile infection risk (odds ratio, 3.13 [95% CI, 1.13–8.68], P=.028) and may offer an antimicrobial stewardship target among surgical patients.
Infect. Control Hosp. Epidemiol. 2015;36(11):1351–1354
A radio survey at a frequency of 843 MHz of 36 square degrees containing the Small Magellanic Cloud (SMC) has been made with the Molonglo Observatory Synthesis Telescope (MOST). The angular resolution is around 45 arcsec and the rms noise is about 1 mJy per beam. The radio image of the region is presented showing over a thousand sources with a variety of angular sizes from unresolved to 10 arcmin. Most of the sources are presumed to be background objects but about 70 of the more extended sources are H II regions or supernova remnants within the SMC.
Central line-associated bloodstream infection (CLABSI) is a national target for mandatory reporting and a Centers for Medicare and Medicaid Services target for value-based purchasing. Differences in chart review versus claims-based metrics used by national agencies and groups raise concerns about the validity of these measures.
Evaluate consistency and reasons for discordance among chart review and claims-based CLABSI events.
We conducted 2 multicenter retrospective cohort studies within 6 academic institutions. A total of 150 consecutive patients were identified with CLABSI on the basis of National Healthcare Safety Network (NHSN) criteria (NHSN cohort), and an additional 150 consecutive patients were identified with CLABSI on the basis of claims codes (claims cohort). Ail events had full-text medical record reviews and were identified as concordant or discordant with the other metric.
In the NHSN cohort, there were 152 CLABSIs among 150 patients, and 73.0% of these cases were discordant with claims data. Common reasons for the lack of associated claims codes included coding omission and lack of physician documentation of bacteremia cause. In the claims cohort, there were 150 CLABSIs among 150 patients, and 65.3% of these cases were discordant with NHSN criteria. Common reasons for the lack of NHSN reporting were identification of non-CLABSI with bacteremia meeting Centers for Disease Control and Prevention (CDC) criteria for an alternative infection source.
Substantial discordance between NHSN and claims-based CLABSI indicators persists. Compared with standardized CDC chart review criteria, claims data often had both coding omissions and misclassification of non-CLABSI infections as CLABSI. Additionally, claims did not identify any additional CLABSIs for CDC reporting. NHSN criteria are a more consistent interhospital standard for CLABSI reporting.
One consequence of “high stakes testing” in Tuscaloosa area schools has been exclusion of materials science faculty from any meaningful participation in middle and high school classrooms. Beyond the loss of resources from the classroom that Materials Science faculty and their students represent, this also has negative consequences for faculty wanting to build ties to schools to address NSF’s “broader impact” criteria. A group of STEM and Education faculty at The University of Alabama have been testing a team based approach designed to overcome the systemic constraints that prevent effective STEM/K-12 collaboration. Teams consisting of a high school teacher, a STEM faculty member, and a STEM graduate student have spent three weeks during summer 2010 to identify/develop and implement an inquiry based science experiments. The experiments are being tested on science campers at McWane Science Center prior to being assessed in the teachers’ classrooms during the fall semester. The experiments were chosen by each team and represent significant advances over those currently available in the schools. By setting a problem that no team member is able to solve alone an environment was produced where success requires meaningful collaboration. Preliminary qualitative evaluation indicates deeper understanding of the school environment by the STEM faculty and greater respect for the skills teachers bring to this endeavor. Successes in this pilot program have generated credibility with the local school district, opening the door to scaling up the project, and developing further positive ties. Incorporation of lead teachers from Alabama Science in Motion also allows the experiments developed to be widely disseminated throughout Alabama, as well as providing a mechanism to identify existing experiments to enhance.
The term ‘field propagation and release’ refers to the breeding of captive adults in large field enclosures, allowing them to raise their young, and then releasing those young from that location. This technique is currently being implemented in Canada as one of several recovery tools for the endangered eastern loggerhead shrike Lanius ludovicianus migrans. During 2001–2007 a total of 360 shrike fledglings were produced in field propagation enclosures and 301 were released from these enclosures. Annual return rates of birds released since 2004 are 2–6.6%. Seventeen released birds have been re-sighted, including 10 birds that have returned to the breeding grounds the following season to produce young with wild mates. The high annual return rate of release birds and the successful integration of these birds into the wild breeding population represent important milestones for the recovery of this population. The management technique we describe here has the potential to be applicable to other species that require natural habitat for breeding and/or are reliant on a suite of parent-learned behaviours that cannot be accommodated for or adequately replicated within intensive close captive-breeding or hand-rearing conditions.
As new and more effective treatments for Alzheimer's disease (AD) emerge, the development of efficient screening strategies in educationally and racially diverse primary care settings has increased in importance. A set of candidate screening tests and an independent diagnostic assessment were administered to a sample of 318 patients treated at a geriatric primary care center. Fifty-six subjects met criteria for dementia. Exploratory analysis led to the development of three two-stage screening strategies that differed in the composition of the first stage or Rapid Dementia Screen, which is applied to all patients over the age of 65. The second stage, applied to those patients who screen positively for dementia, is accomplished with the Free and Cued Selective Reminding Test to detect memory impairment. Using clinical diagnosis as a gold standard, the strategies had high sensitivity and specificity for identifying dementia and performed better for identifying AD than non-AD dementias. Sensitivity and specificity did not differ by race or education. The strategies provide an efficient approach to screening for early dementia. (JINS, 2008, 14, 130–142.)