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Alcohol use in women increases dramatically
AUSTRALIAN researchers say they have unique evidence that alcohol use among women in Australia has increased during the past 3 decades. The research, published in JAMA Psychiatry, observed a dramatic increase between two generations of women which was more pronounced at higher levels of drinking. The researchers used data from the Mater University Study of Pregnancy, a prospective prebirth cohort study that recruited all pregnant mothers attending a Brisbane hospital between 1981 and 1983. The alcohol use analyses were restricted to 1053 mothers aged 18‒25 years at baseline and their daughters who were between the same ages when assessed 21 years later. They found that daughters had more than five times the odds of consuming the highest recorded level of alcohol (more than 30 glasses of alcohol per month) and 2.8 times the odds of consuming the next highest level of alcohol (7‒30 glasses per month) than their mothers at the same age. In both generational cohorts, increased use of alcohol was associated with not having a dependent child, which the authors speculated was likely due to increasing opportunities to consume alcohol by lengthening the time spent socialising with friends without parental responsibilities. However, the authors admitted limitations to their research, particularly the fact that the mothers were recruited while pregnant, while daughters were recruited because they were the biological children of mothers in the study. “Future research is urgently needed to confirm the possibility that the recent increase in female drinking in wealthy countries is perhaps higher than previously thought”, they wrote. In a separate study published in the Australian and New Zealand Journal of Public Health researchers found rates of any drinking and at-risk drinking (>14 US standard drinks/week) in middle-aged and older adults were higher for males than females in Australia, the US and Korea. They also found that in Australia, at-risk drinking was associated with higher income.
Call to prolong AF monitoring after unexplained stroke
PROLONGED monitoring of heart rhythm should become part of standard care of patients with cryptogenic stroke, according to an editorial published in the New England Journal of Medicine. The editorial was commenting on two studies that showed prolonged rhythm monitoring identified atrial fibrillation (AF) “that would not have otherwise declared itself”. Both studies enrolled patients with recent cryptogenic stroke or transient ischaemic attack (TIA) and no history of AF. Before enrolment, patients underwent at least 24 hours of continuous rhythm monitoring without evidence of AF. One randomised controlled study included 441 patients aged 40 years and older and assessed whether long-term monitoring with an insertable cardiac monitor (ICM) was more effective than conventional follow-up for detecting AF in patients with cryptogenic stroke. It found that by 6 months, AF had been detected in 8.9% of patients in the ICM group (19 patients) and 1.4% of patients in the control group (3 patients). By 12 months, AF had been detected in 12.4% of patients in the ICM group (29 patients) and 2.0% of patients in the control group (4 patients). The second study included 572 patients aged 55 years or older without known AF who had a cryptogenic ischaemic stroke or TIA within the previous 6 months, with the cause undetermined after standard tests, including 24-hour electrocardiography (ECG). They were randomly assigned to undergo additional non-invasive ambulatory ECG monitoring with either a 30-day event-triggered recorder or a conventional 24-hour monitor. AF lasting 30 seconds or longer was detected in 45 of 280 patients (16.1%) in the intervention group and nine of 277 (3.2%) in the control group. AF lasting 2.5 minutes or longer was present in 28 of 284 patients (9.9%) in the intervention group and seven of 277 (2.5%) in the control group. By 90 days, oral anticoagulant therapy had been prescribed for more patients in the intervention group (52 of 280 patients [18.6%]) than in the control group (31 of 279 [11.1%]). The editorial author wrote that the weight of current evidence suggested subclinical AF was a modifiable risk factor for stroke recurrence, and its presence should be ruled out in this high-risk population. “Therefore, most patients with cryptogenic stroke or transient ischemic attack should undergo at least several weeks of rhythm monitoring”, he wrote.
Telemedicine detects retinopathy in premmie babies
US research provides “strong support” for using a telemedicine system including trained non-physician imagers and readers to detect retinopathy of prematurity (ROP) that requires referral in infants at risk. The research, published in JAMA Ophthalmology, included 1257 infants (mean birth weight, 864 g; mean gestational age, 27 weeks) in 13 North American neonatal intensive care units who underwent regularly scheduled diagnostic examinations by an ophthalmologist and digital imaging by non-physician staff using a wide-field digital camera. Ophthalmologists documented findings consistent with referral-warranted (RW) ROP. The researchers found that when image-set grading of an eye was compared with diagnostic examination, the sensitivity for detection of RW-ROP was 81.9%, with a specificity of 90.1%. When both eyes of an infant were considered, the sensitivity increased to 90.0%, with specificity of 87.0%. “Importantly, among infants treated for ROP, the sensitivity of image grading increased to 98.2%”, the researchers wrote. “When compared with the criterion standard diagnostic examination, these results provide strong support for the validity of remote evaluation by trained nonphysician readers of digital retinal images taken by trained nonphysician imagers from infants at risk for RW-ROP”, they wrote.
Pertussis identified in school children with persistent cough
PERTUSSIS has been found in a fifth of UK school-aged children who presented to primary care with persistent cough, according to research published in the BMJ. The recruited cohort included 279 children aged 5‒15 years who presented with persistent cough of 2‒8 weeks’ duration. Among these, the researchers found more than 90% coverage with complete primary pertussis vaccinations and about 80% coverage with the preschool booster vaccination. The study excluded cough likely to be caused by a serious underlying medical condition, known immunodeficiency or immunocompromise, and receipt of the preschool pertussis booster vaccination within the previous year. The researchers found 56 children (20%) had evidence of recent pertussis infection, of whom 39 had been fully vaccinated. In children who had received the preschool pertussis booster vaccination 7 years or more previously, the risk of pertussis was more than three times higher than in those who had received it less than 7 years previously. Of six children with laboratory-confirmed pertussis who had cough frequency measured, four coughed more than 400 times in 24 hours. “Our findings show that a significant burden of illness associated with pertussis remains among school age children who present in UK primary care with persistent cough, even after implementation of the preschool pertussis booster vaccination and despite high levels of vaccination coverage”, the researchers wrote.
Research violations exposed
A RETROSPECIVE review of 84 warning letters sent by the US Food and Drug Administration (FDA) to research stakeholders — clinical investigators, institutional review boards (IRBs) and sponsors — about violations has found these related to a variety of failures, including failure to protect participant safety, report adverse events to IRBs and personally supervise a study. The analysis, published in the Journal of Medical Ethics, found nine specific violations from warning letters sent over 2 years (2011‒2012) to clinical investigators and 10 violations in letters to IRBs, and 8 years of data (2005‒2012) for sponsors, relating to 22 specific violations. Of the 20 letters sent to clinical investigators, 19 related to the violation of deviation from the investigational plan (95%). The researchers also found that study supervision by investigators had significantly worsened when compared with previous similar studies. However, they did find non-significant improvements with maintenance of adequate and accurate case records and histories, retention of and production of records for inspection, issues relating to informed consent and violations related to the investigational product. They found two new violations compared with previous studies — failure to obtain IRB approval and submission of false information to the FDA and sponsors. “The two pillars of good clinical practice are independent review of a protocol and the informed consent document; if these are bypassed, study integrity is compromised”, the researchers wrote. “The provision of false information to the FDA is research fraud.” They wrote that the violations by clinical research stakeholders had happened despite stringent regulation in the US. “In order to curb the frequency of violations in the USA and worldwide, regulations must be enforced through timely and proper monitoring of all stakeholder sites. Every research participant is responsible for adhering to uniform standards and maintaining ethical principles”, they wrote.
Indoor dogs may reduce diabetes risk
CHILDREN exposed to an indoor dog had a reduced odds of developing preclinical type 1 diabetes compared with otherwise similar children without indoor dog exposure, according to research published in JAMA Pediatrics. The study included 3143 consecutively born children at two hospitals in Finland between 1996 and 2004. Included children had HLA antigen-DQB1-conferred susceptibility to type 1 diabetes measured in cord blood samples, had not received a clinical diagnosis of type 1 diabetes at age 5 years, and returned an allergy questionnaire. Follow-up for development of clinical and pre-clinical type 1 diabetes (defined as repeated positivity for islet-cell antibodies plus at least 1 of 3 other diabetes-associated autoantibodies) was available until 1 January 2013. The allergy questionnaire, completed when the child was aged 5 years, covered several farming- and animal contact-related factors, day care attendance, and antibiotic use during early infancy. Preclinical type 1 diabetes was present in 5.5% of the children (173 of 3143) and clinical type 1 diabetes in 1.6% (51 of 3143) in the complete case dataset. The median follow-up was 10 years for preclinical and 12.2 years for clinical type 1 diabetes. Of nine early microbial exposures studied, only indoor dog exposure was inversely associated with subsequent development of preclinical type 1 diabetes. In children exposed to indoor dogs the adjusted odds ratio (OR) for developing preclinical type 1 diabetes was 0.47 and for developing clinical type 1 diabetes the OR was 0.40. All other microbial exposures studied were not associated with preclinical or clinical diabetes — ORs ranged from 0.74 to 1.58. “This association was consistently seen in both complete case and multiple imputation data analyses”, the researchers wrote. They found outdoor dog exposure showed a non-significant OR of 1.14 with preclinical diabetes outcome. “Dog contact may affect the human immune system in many ways”, they wrote. “In addition to affecting adaptive immune responses, early exposure to dogs may reduce innate immunity responses.”