Patrick Campbell

Data from a new analysis is reinforcing the heightened concern surrounding the detrimental impact use of the novel osteoporotic therapy romosozumab can have on cardiovascular health.   

Results of the statistical analysis, which included data from a pair of phase 3 clinical trials and the UK Biobank cohort, concluded patients whose DNA carried genetic markers mimicking the effects of the novel sclerostin inhibitor had an 18% greater chance of suffering a heart attack.

“Our findings support the warning labels issued by regulatory authorities such as the FDA and EMA, and suggest that the cardiovascular effects seen in some trials of this medicine are real,” said lead investigator Jonas Bovjin, MBChB, MSc, of the Big Data Institute at the University of Oxford, in a statement. “This emphasizes the importance of conducting further rigorous clinical studies to evaluate the cardiovascular safety of this class of medicines.”

A collaborative effort between investigators from Oxford, University of Tartu, Broad Institute, Massachusetts General Hospital, and the University of Bristol, the current study was designed to assess the potential for cardiovascular complications associated with romosozumab using data from clinical trials and the UK Biobank cohort in 2 separate analyses.

Articles

Data from a new analysis reinforces concerns surrounding the detrimental impact the novel osteoporotic therapy romosozumab can have on cardiovascular health.

Concerns Over Cardiovascular Risk From Treatment With Osteoporotic Therapy

New research suggests consuming more whole grains could lower a person’s risk of developing type 2 diabetes.

Presented at Nutrition Live Online 2020, a virtual conference hosted by the American Society for Nutrition (ASN), results of the analysis indicate substituting calories with high quality carbohydrates, such as those in whole grains, could reduce risk of developing type 2 diabetes while substitution with low quality carbohydrates, such as those from refined grains, sugary foods, and potatoes, was found to increase risk.

"These results highlight the importance of distinguishing between carbohydrates from high- and low- quality sources when examining diabetes risk," said lead investigator Kim Braun, PhD, a postdoctoral research fellow from Erasmus University Medical Center and Harvard T.H. Chan School of Public Health, in a statement. "Conducting similar studies in people with various socio-economic backgrounds, ethnicities and age will provide insight into how applicable these findings are for other groups."

With previous research indicating carbohydrate intake was associated with higher risk of type 2 diabetes, Braun and a team of colleagues sought to determine the specific effects of high and low quality carbohydrates on this association. Additionally, investigators hoped to evaluate whether overall macronutrient composition could have an impact on this effect.

For the purpose of analysis, investigators designed the current study to assess associations of isocalorically substituting high quality carbohydrates and low quality carbohydrates with other macronutrients on type 2 diabetes risk. Using the Nurses’ Health Study, Nurses’ Health Study 2, and the Health Professionals Follow-up Study, investigators identified cohorts of 69,949 women, 90,239 women, and 40,539, respectively.

Click to continue reading on HCP Live.com

Substituting calories with high quality carbohydrates, such as those in whole grains, could reduce risk of developing type 2 diabetes 

High Quality Carbohydrates May Reduce Type 2 Diabetes Risk

A recent study into the usability of Electronic Health Records (EHR) has found that basic enhancements to the EHR system could be associated with better physician cognitive workload and performance.

Investigators found that physicians who used a system with enhanced longitudinal tracking had appropriately managed significantly more abnormal test results compared with physicians using baseline EHRs.

Investigators from the University of North Carolina sent out invitations to all residents and fellows enrolled in the school of medicine at a large academic institution, stating the need for experience with using the Epic EHR software in reviewing test results to undergo the study’s simulated situations. Investigators offered a $100 gift card as an incentive for participation. A total of 40 individuals were recruited to participate, but 2 of them were excluded due to numerous cancellations. Between April 1, 2016 and Dec. 23, 2016, those 38 participants were enrolled and blindly allocated to a simulated EHR environment. Of those 38, 20 were assigned to use a baseline EHR and 18 were assigned to enhanced EHRs, which included changes intended to enhance longitudinal tracking of abnormal test results in the system.

The baseline EHR, which was currently being used at the study institution, displayed all new abnormal test results and identified critical test results for patients with no-show status in a general folder called “Results” and had basic sorting capabilities. The enhanced EHR automatically sorted all previously identified critical test results for patients with a no-show status in a dedicated folder called “All Reminders.”

Additionally, the enhanced EHR clearly displayed information regarding patient status and policy-based decision support instructions. The interventions were developed based on the classic theory of attention, which indicates that cognitive workload varies continuously during the course of a task and changes of cognitive workload may be attributed to adaptive interaction strategies.

Investigators found no statistically significant difference in perceived workload between the two groups. However, a statistically significant higher cognitive workload, as shown by the lower mean blink rate, was found in the baseline EHR group compared with the enhanced EHR group.

Investigators noted statistically significant poorer performance in the baseline EHR group compared with the enhanced EHR group. They attributed this to review of patients with a no-show status for a follow-up appointment. No difference between the groups was noted in terms of the time to complete simulated scenarios. Additionally, no statistically significant difference was noted in fatigue levels between baseline and enhanced EHR groups.

®, Lukasz Mazur, PhD, associate professor at the UNC School of Medicine and study author, stated the importance of studies like this cannot be understated as improving EHRs are imperative to a physician's performance. 

"There is a need to quantify, in a rigorous and scientific manner, the effect of usability on physicians’ mental workload and performance. Such evidence can help us create the ‘burning platform’ for the usability improvements within EHRs," Mazur said. "We can not expect physicians to do their job efficiently and effectively without properly designing their EHR-related workflows. I hope that our manuscript and findings can spearhead some policy changes aimed at making usability a centerpiece of next generation of EHRs."

Investigators concluded there were several limitations to their study. The size of their study meant they could not consider possible confounding factors and were unable to more accurately quantify the association of usability with cognitive workload and performance. The simulated environment, where the participants knew that their work was being assessed, may have impacted performance. The cognitive workload and performance scores were likely impacted by the setting and might not reflect the actual cognitive workload and performance in real clinical settings.

Investigators found that the intervention might have manipulated the ease of access to information through a reorganized display and learning because it provided a guide to action by clearly showing information on patients’ status and policy-based decision supports. Investigators noted that future research could more accurately quantify the association of usability and learning with cognitive workload and performance.

Association of the Usability of Electronic Health Records With Cognitive Workload and Performance Levels Among Physicians,”

Journal of the American Medical Association. 

This article was originally published by 

Physicians who used an electronic health record system found to have a better cognitive workload and performance.

Electronic Health Records Could Improve Caregiver Workload, Performance

A recent study has found that a person’s chance of developing multiple sclerosis (MS) later in life may be linked to their body mass index (BMI) at menarche.

While previous studies have suggested people who are younger when they enter puberty are more likely to develop MS, a study examining 329,245 women found a link between increased BMI and development of MS.

Investigators found a 1-year increase in genetically predicted age at puberty decreased odds of MS by 8%. A multivariable Mendelian randomization (MR) analysis showed that after accounting for effects on adult BMI, the association of age at puberty with MS susceptibility was reduced. Investigators obtained similar results when childhood BMI was incorporated. Sensitivity analyses provided no evidence of major bias from genetic pleiotropy.

"Previous studies have shown that children with higher body weight tend to enter puberty earlier than children with normal body weight, and increased BMI is also linked to a greater risk of MS," said study author J. Brent Richards, MD, MSc, of McGill University in Montreal, Canada. "It appears that earlier age at puberty is associated with an increased risk of MS, but this association is influenced by BMI. Our findings do not support a substantial role for the effect of the timing of puberty on the risk of MS independent of BMI."

Investigators reviewed a genome-wide association study of 329,245 women and 372 genetic variants that are associated with the age at menarche. Previous studies had shown that the genes related to the timing of puberty are well-correlated in girls and boys. The effect of pubertal timing on risk of MS was measured with summary statistics from a GWAS of 14,802 cases with MS and 26,703 controls, who did not have the disease, to examine whether age of puberty was associated with risk of MS.

Investigators found support for an association between higher age at puberty and decreased risk of MS with a significance comparable to that reported in observational studies. The effect appeared to be largely mediated by the strong association between age at puberty and obesity. Authors noted that a large cause effect of pubertal timing independent of BMI was unlikely, based upon results. 

Richards noted that while they did find that people with an earlier age of puberty were more likely to develop MS, but once they factored in BMI, the results were no longer significant.

One of the limitations of the study that researchers took note of was that they were unable to analyze results for men and women separately. 

"More research is needed to determine whether decreasing rates of obesity could help to reduce the prevalence of MS," Richards said. "If so, this could be another important reason for public health initiatives to focus on lowering obesity rates.”

This study, “Effect of age at puberty on risk of multiple sclerosis,” was published in 

®, the medical journal of the American Academy of Neurology. 

Higher body mass index at beginning of menstruation linked to greater risk of developing multiple sclerosis.