The outcomes of clinical trials are often affected by the diversity of the patient population studied.  Things like race and gender can make a real difference in the way drugs work– and yet women, minorities and older adults continue to be underrepresented in pivotal trials for new medications .  Two recent studies demonstrate that fact over the last several decades.  And although the proportion of these populations enrolled in clinical trials has increased, it is still well out of step with the number of patients affected by the diseases in question. Sr. Editor Gretchen Cuda Kroen spoke with Dr. Erin Michos,  co-author  on those studies about the origins of the disparity, and what what we can do about it.

Khan MS, Shahid I, Siddiqi TJ, et al. Ten-Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs. J Am Heart Assoc. 2020;9(11):e015594. 

Khan SU, Khan MZ, Raghu Subramanian C, et al. Participation of Women and Older Participants in Randomized Clinical Trials of Lipid-Lowering Therapies: A Systematic Review. JAMA Netw Open. 2020;3(5):e205202. Published 2020 May 1. 

Articles

Women, Minorities and Older Adults Still Underrepresented in Clinical Trials: Conversation with Erin Michos MD

New guidelines for glucose management in diabetic COVID patients were 

 in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.  

According to the report, more than 20 percent of COVID patients in the ICU are patients with diabetes, presenting challenges for the clinicians managing their care.  Diabetic patients with COVID-19 in the ICU need both complex medical management of their COVID disease, along with blood sugar control to minimize complications and mortality risk- and that can require multiple patient interactions that put the provider at risk.

“This manuscript provides guidance for healthcare providers caring for patients hospitalized for COVID-19 who also have a prior history of diabetes or who have high blood sugar levels at the time of hospitalization,” said lead author Mary T. Korytkowski, M.D., of the University of Pittsburgh School of Medicine in Pittsburgh, Pa. “These healthcare providers are at risk for contracting COVID-19, and while glycemic management in the hospital improves patient outcomes, it also intensifies the amount of time with direct patient contact.”

Clinicians may limit their risk of exposure by minimizing the use of IV insulin infusions and using remote glucose monitoring devices and non-insulin therapies when possible. Diabetes self-management by selected patients who are knowledgeable and capable of this in the hospital also can be considered as a way of limiting direct patient interactions. Clinicians should be aware that some medications used in treating COVID-19 patients, including glucocorticoids and hydroxychloroquine, can affect blood glucose levels.

Korytkowski M, Antinori-Lent K, Drincic A, et al. A Pragmatic Approach to Inpatient Diabetes Management during the COVID-19 Pandemic [published online ahead of print, 2020 Jun 4]. J Clin Endocrinol Metab. 2020;dgaa342. 

New Guidance for Treating Diabetic COVID-19 Patients in the ICU

Hypertensive patients have a two-fold increased risk of dying from the coronavirus COVID-19 compared to patients without high blood pressure, according to 

.  In addition, if the hypertension is untreated, the risk is greater.

But perhaps more significantly, the researchers found that those patients whose hypertension was treated with renin-angiotensin-aldosterone system inhibiting drugs ( which  includes  ACE2 inhibitors and ARB’s ) had lower mortality than those who were not, suggesting that these drugs may be protective in COVID-19 patients instead of detrimental as previously suggested.

The study examined data from 2866 patients with COVID-19 who were admitted to Huo Shen Shan hospital in Wuhan, China, between 5 February and 15 March 2020.  Of these patients, 29.5% (850) had a medical history of high blood pressure (hypertension).

Out of 850 hypertensive patients, 710 were being treated with medication and 140 were not.

In total, 34 of the 850 patients with hypertension (4%)  died of cornonavirus compared to 22 out of 2027 patients without hypertension (1.1%) - a 2.12-fold increased risk after adjustment for factors that could affect the results, such as age, sex and other medical conditions.

Among the patients with hypertension who were not taking medication for the condition, 11 out 140 (7.9%) died from coronavirus compared to 23 out of 710 (3.2%) of those who were taking medication - 2.17-fold increased risk after adjusting for confounding factors.

In a further meta-analysis, the researchers pooled the data from the Huo Shen Wan patients with data from nearly 2,300 patients in three other studies to investigate the death rates in patients being treated with drugs to control blood pressure levels by targeting the renin-angiotensin-aldosterone system (RAAS). These drugs include angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). Other, non-RAAS inhibiting drugs used for treating high blood pressure include beta blockers, calcium channel blockers (CCBs) or diuretics.

They found a lower risk of death among the 183 patients treated with RAAS inhibitors than in 527 patients treated with other drugs. However, the researchers say this result should be treated with caution as the number of patients in this analysis was small and so it could be due to chance.

Researchers emphasize the importance that hypertensive patients understand that they are at increased risk of COVID-19, and that they continue to take their medications as prescribed.

"Soon after we started to treat COVID-19 patients in early February in Wuhan, we noticed that nearly half of the patients who died had high blood pressure, which was a much higher percentage compared to those with only mild COVID-19 symptoms. At the same time, some researchers were raising concerns that RAAS inhibitors might be facilitating the entry of the coronavirus into cells and making people more susceptible to the disease,” said Professor Ling Tao of Xijing Hospital and one the paper’s authors.

"We were quite surprised that these results did not support our initial hypothesis; in fact, the results were in the opposite direction, with a trend in favour of ACE inhibitors and ARBs. We think this is exactly why practice based on clinical evidence is more vital than ever," Tao said.

The authors point out that this is a retrospective study with a relatively small sample size and so the results should be interpreted with caution.  However, it does support the initial recommendations of many societies that patient’s should not discontinue ACE’s and ARBs, and, a 


	has also suggested that antihypertensive medications, such as ACE inhibitors and ARBs are not associated with an increased risk of testing positive for COVID-19.

"Association of hypertension and antihypertensive treatment with COVID-19 mortality: a retrospective observational study", by Chao Gao et al. European Heart Journal. 

"Renin-angiotensin-aldosterone system blockers and the risk of COVID-19", by Giuseppe Mancia et al. New England Journal of Medicine, 1 May 2020. 

"Renin-angiotensin system inhibitors in the COVID-19 pandemic: consequences of antihypertensive drugs", by Luis M. Ruilope et al. European Heart Journal. 

Hypertensive patients have a two-fold increased risk of dying from the coronavirus COVID-19 compared to patients without high blood pressure, according to new research published in the European Heart Journal.  In addition, if the hypertension is untreated, the risk is greater.

ACE’s and ARBs Not Linked to COVID-19 Mortality But Hypertension Doubles Risk

When asked to elderly patients undergoing coronary artery calcium (CAC) scans, the results of a single question offer providers a better understanding of the individual’s risk of death: "On a scale of 1 - 10, how much do you exercise (0-none, 10-always)?"

As it turns out, Elderly patients with high levels of atherosclerosis detected by CAC scans, who reported very frequent exercise, had a lower mortality rate than patients who reported getting little or no exercise and a mortality rate similar to patients with low levels of atherosclerosis who exercised rarely or never.  In other words, regular exercise overcomes the negative impact of atherosclerotic disease – at least in terms of mortality.

Mayo Clinic Proceedings: Innovations, Quality & Outcomes

"Our study is the first to assess - and show - that this assessment of exercise activity in the elderly strongly influences the risk of death when significant atherosclerosis is detected on CAC scanning," explained lead investigator Alan Rozanski, MD, Professor of Medicine (Cardiology) at the Icahn School of Medicine at Mount Sinai, and Director of Nuclear Cardiology and Cardiac Stress Testing and Chief Academic Officer for the Department of Cardiology at Mount Sinai Morningside, New York, NY, USA.

"A notable aspect was that the use of just a single, self-reported question regarding exercise served to risk stratify older patients if they had elevated coronary artery calcium scores," said Rozanski.

The research examined data from  2,318 patients between the ages of 65 and 84 years who were referred for CAC screening between August 1998 and November 2016, and who died more than one year after the scan. The patients completed a questionnaire at the time of their scan, which asked about chest pain symptoms, cardiac risk factors, medication use, and physical activity. Patients self-reported their physical activity on a scale from 0-none to 10-always. Resting heart rate, blood pressure, height, and weight were recorded. Medical history of dyslipidemia, diabetes, hypertension, and smoking was identified.

The patients were followed for an average of 10.6 years to assess rates of death. During this time, 23 percent had died. For the entire cohort, the annualized mortality rate was 2.3 percent per year, with the highest mortality occurring among patients reporting low physical activity (2.9 percent per year) and the lowest mortality occurring among patients reporting high physical activity (1.7 percent per year).

Among patients with low CAC scores (0-99), survival was similar for each level of physical activity. In contrast, in patients with moderate CAC scores (100-399), the risk for all-cause mortality increased 2.07-fold among patients with low physical activity compared with patients with high physical activity. In patients with CAC scores over 400, all-cause mortality increased 2.35-fold for patients with low versus high activity.

Among all clinical parameters, age and the magnitude of CAC score were the most potent predictors of mortality. Notably, among all other variables, including chest pain symptoms, smoking, and obesity, physical activity was the next most potent predictor.

Dr. Rozanski and colleagues noted that there are several factors that could explain the observations of this study. For example, patients who reported high physical activity had better health profiles, with lower frequency of hypertension, smoking, and diabetes. Of patients reporting high physical activity, only 7.7 percent were obese, while more than 25 percent of patients reporting low physical activity were obese.

"Our results indicate that a simple assessment of self-reported daily-life physical activity can substantially improve the effectiveness of CAC scanning for risk stratifying older adults and is strongly encouraged," said Dr. Rozanski. "This is consistent with recent suggestions to make assessment of physical activity a 'fifth vital sign' that should be entered into patient electronic medical records, along with body temperature, pulse rate, respiration rate, and blood pressure."

"Associations Among Self-reported Physical Activity, Coronary Artery Calcium Scores, and Mortality Risk in Older Adults," by Alan Rozanski, MD; Yoav Arnson, MD; Heidi Gransar, MS; Sean W. Hayes, MD; John D. Friedman, MD; Louise E.J. Thomson, MBChB; Damini Dey, PhD; and Daniel S. Berman, MD (

https://doi.org/10.1016/j.mayocpiqo.2020.02.005

). It appears in Mayo Clinic Proceedings: Innovations, Quality & Outcomes volume 4, issue 3 (June 2020) published by Elsevier. It is openly available.

Mortality Estimates in Elderly Atherosclerosis Patients Improved By Knowledge of Exercise Habits

When antihypertensive medications are taken with regularity, life expectancy is increased says 

published in the American Heart Association Journal 

Although the conclusion at first seems obvious, researchers say that many clinical studies fail to include older patients who may be medically more frail, leaving clinicians to wonder if the benefits seen those studies are representative of their more fragile patients.

"We knew that high blood pressure medication was protective in general among older people, however, we focused on whether it is also protective in frail patients with many other medical conditions who are usually excluded from randomized trials," said Giuseppe Mancia, M.D., lead study author and professor emeritus at the University of Milano-Bicocca in Milan, Italy.

Researchers reviewed data on almost 1.3 million people aged 65 and older (average age 76) in the Lombardy region of northern Italy who had 3 or more high blood pressure medication prescriptions in 2011-2012. Examining the public health care database, researchers calculated the percentage of time over the next seven years (or until death) that each person continued to receive the medications. Because almost all medications are free or low-cost and dispensed by the public health service, this corresponds roughly to people's adherence in using the medication in Italy.

To look separately at outcomes among older people with various medical conditions, researchers used a previously developed score that accounts for 34 different health factors and has a close relationship with mortality.

Researchers compared roughly 255,000 people who died during the 7-year follow-up with age-, gender-, and health-status-matched controls who survived and divided them into four groups of health status: good, medium, poor or very poor.

The probability of death over 7-years was 16% for people rated in good health at the beginning of the study. Mortality probability increased progressively to 64% for those rated in very poor health.

Compared with people with very low adherence to blood pressure medications (dispensed pills covered less than 25% of the time period), people with high adherence to blood pressure medications (more than 75% of the time period covered) were 44% less likely to die if they started in good health and 33% less likely to die if they started in very poor health.

A similar pattern was seen with cardiovascular deaths. The greatest survival benefit was among the people who started in good health, and the most modest survival benefit was in those who started in very poor health.

"Our findings definitely suggest that even in very frail people, antihypertensive treatment reduces the risk of death; however, the benefits may be smaller in this group," Mancia said.
	No matter what a person's initial health status, survival benefits were greatest in those who received blood pressure medication to cover more than 75% of the follow-up period, compared with those with intermediate (25-75%) or low levels (less than 25%) of coverage, highlighting the importance of consistent use of blood pressure medications.

"Do your best to encourage and support patients to take their medications, because adherence is crucial to getting the benefits. Medications do nothing if people don't take them," Mancia said.

Prescription medications given to elderly people living in nursing homes or assisted-living homes in Italy are not included in the national database, so the study's results may only apply to elderly people living in the community. In addition, all data for this analysis are from Italy, where hospitalizations and blood pressure medications are available for free or at low cost, thus, the study's findings may not be generalizable to countries with a different health care system.

Federico Rea, Anna Cantarutti, Luca Merlino, Andrea Ungar, Giovanni Corrao, Giuseppe Mancia. Antihypertensive Treatment in Elderly Frail Patients. Hypertension, 2020; 

When antihypertensive medications are taken with regularity, life expectancy is increased says a new study published in the American Heart Association Journal Hypertension.

Diabetes and Heart Disease? Adherence to Antihypertensive Drugs Increase Life Expectancy in Frail Elderly Populations

Women exposed to Per- and polyfluoroalkyl substance (PFAS), a chemical commonly used in nonstick and waterproof products and firefighting foams, experience menopause earlier according to a study published in the Endocrine Society’s 

Journal of Clinical Endocrinology & Metabolism

Study of Women’s Health Across the Nation

 (SWAN), a 17-year-long prospective cohort study. Researchers examined1,120 midlife women and found that women with high PFAS levels in their blood samples reached menopause two years earlier than those with lower levels.

Early menopause can have an impact on the heart and bone health of women say the researchers. 

“Even menopause a few years earlier than usual could have a significant impact on cardiovascular and bone health, quality of life, and overall health in general among women,” said corresponding author Sung Kyun Park, Sc.D., M.P.H., of the University of Michigan School of Public Health.

The authors say this is a problem for human health because these chemicals persist in the environment and build up in the body, ultimately interfering with hormone regulation explains the study’s lead author Ning Ding, Ph.D., M.P.H., of the University of Michigan School of Public Health in Ann Arbor, Mich. “Because of their persistence in humans and potentially detrimental effects on ovarian function, it is important to raise awareness of this issue and reduce exposure to these chemicals.”

Associations of Perfluoroalkyl Substances with Incident Natural Menopause: The Study of Women’s Health Across the Nation.  Journal of Clinical Endocrinology & Metabolism.

Women exposed to Per- and polyfluoroalkyl substance (PFAS), a chemical commonly used in nonstick and waterproof products and firefighting foams, experience menopause earlier according to a study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.

Chemical Exposure May Cause Early Menopause

Several professional meetings are coming up this month that may be of interest to endocrinologists.

American Diabetes Association Virtual Scientific Sessions

ERA-EDTA (European Renal Association and European Dialysis and Transplant Association) Virtual Congress

SAVE THE DATES!!! 

The oral antiplatelet drug Ticagrelor (Brilinta, Astra Zeneca), was approved this week by the US Food and Drug Administration (FDA) for use in patients with coronary artery disease (CAD) who are at high risk for a first heart attack or stroke.  The change adds new treatment options to diabetic pateints at high risk for cardiac events.

The drug had previously been approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS), and in more than 70 countries for the secondary prevention of CV events among high-risk patients who have experienced a prior myocardial infarction.

This expands the current use to include aspirin plus Brilinta dual antiplatelet therapy in patients who have a high CV risk, but without a history of heart attack or stroke.

The FDA approval was based on positive results from the Phase III THEMIS trial, which demonstrated a statistically significant reduction of cardiovascular events at 36 months in patients with CAD and type-2 diabetes (T2D) at high-risk of a first heart attack or stroke who were treated with aspirin plus Brilinta 60mg versus aspirin alone. 

The data from the THEMIS trial and the THEMIS-PCI sub-analysis were published in 

The expansion of the drug approval has significant benefits for diabetic patients with heart disease, explained Gabriel Steg, MD, THEMIS trial Co-Chair and Professor at UniversitÃ© de Paris. 

“THEMIS for ticagrelor was a large, multi-national trial of more than 19,000 patients with coronary artery disease and type-2 diabetes. Around one third of patients with coronary artery disease have type-2 diabetes, putting them at higher risk of heart attack or stroke, than patients without diabetes,” said Steg. “Today’s approval brings new hope to patients at risk of experiencing a first heart attack or stroke.”

It also adds to the arsenal of treatment options for high risk heart disease patients without diabetes said Deepak L. Bhatt, THEMIS trial Co-Chair and Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital. 

“Coronary artery disease is a potentially life-threatening condition that causes significant morbidity in many people. The addition of ticagrelor to aspirin offers a new therapeutic option to decrease the likelihood of both heart attack and stroke, a significant advance in our ability to treat these high-risk patients.”

The THEMIS trial demonstrated the relative risk reduction of the composite endpoint of heart attack, stroke and CV death by 10% (absolute risk reduction; 0.8%, 7.7% vs 8.5%) with aspirin plus long-term Brilinta compared to aspirin alone in patients who had CAD and T2D without a history of heart attack or stroke. While this indication is not limited to this setting, the efficacy of Brilinta was established in a population with T2D in the THEMIS trial. The safety profile for Brilinta was consistent with the known profile of the medicine with an increased risk of bleeding events observed.

Regulatory submissions to expand the approved indication for Brilinta based on the THEMIS trial are also under regulatory review in the EU, Japan and China.

Ticagrelor Now For Use in Diabetic Patients Without History of MI or Stroke Says FDA

A common problem among diabetic patients is adherence to medications.  A new study has found that colorectal cancer patients who are compliant in taking oral diabetes drugs fare better than those who do not.

Cancer Epidemiology, Biomarkers & Prevention

 a journal of the American Association for Cancer Research.

The association between diabetes and increased incidence of colorectal cancer is well established, explained Sunho Choe. Further, one of the paper’s authors.  The use of the antidiabetic medication metformin has been repeatedly shown to improve colorectal cancer survival among those with diabetes, he said. "However, it is estimated that the majority of patients take additional antidiabetic medications along with metformin, and how the combination of these medications affects the prognosis of colorectal cancer remains underexplored," he added.

In their retrospective cohort study, the researchers used information from the National Health Information Database in Korea, from 2002 to 2016. Individuals who had diabetes and were diagnosed with colorectal cancer in this time frame were included in the study, resulting in a total study population of 33,841 participants. Patients were followed for an average of 4.7 years.

The researchers used prescription data to calculate the patients' proportion of days covered (PDC), which is defined as the number of days with medications on hand divided by the number of days in a specified time interval to estimate patients' adherence to their oral antidiabetic medications. Adherence to prescribed injectable medications, including insulin, was not measured. The researchers categorized oral medication adherence into two groups for comparison: patients with high adherence had a PDC of at least 80 percent, while patients with low adherence had a PDC of less than 80 percent.

The researchers found that over 80 percent of patients were taking more than one oral antidiabetic medication and fewer than 23 percent of patients were in the high-adherence category. Compared to patients with high adherence, those with low adherence to their oral antidiabetic medication had a nearly 20 percent increase in their risk of overall mortality, in both crude and adjusted models.

High adherence to oral antidiabetic medication was found to have a protective effect for all colorectal cancer subgroups, with the most pronounced effect observed among patients with distal colon cancer.

"Based on our data, less than 25 percent of patients were taking their diabetes medications as prescribed, suggesting that over 75 percent of diabetic patients with colorectal cancer could benefit by adhering to these prescriptions," said Senior author Aesun Shin.

The researchers did not have access to some clinical information, including cancer stage, which is an important factor in comparing prognoses between different groups. In lieu of cancer stage, the researchers stratified the study population based on type of cancer treatment received. Patients who had early-stage disease likely received surgery alone, while patients with late-stage disease likely received palliative therapy, such as chemotherapy or radiotherapy without surgery.


	Choe S, Lee J, Park JW, et al. Prognosis of Patients with Colorectal Cancer with Diabetes According to Medication Adherence: A Population-Based Cohort Study. Cancer Epidemiol Biomarkers Prev. 2020;29(6):1120â1127. doi:10.1158/1055-9965.EPI-19-1455

Oral Diabetes Drugs May Improve Survival In Diabetics With Colorectal Cancer

How good are your diagnostic skills?  Test them here with this month's Visual Dx quiz!

A 50-year-old man has arrives at urgent care complaining of nausea and vomiting. The doctor observes an altered mental state, shaking, and suspects long-term alcohol abuse based on the exam. The patient has a pruritic rash on both hands that look like “gloves” and around his neck in the shape of a necklace.


	A. Pellagra
	B. Hepatitis C
	C. Atopic dermatitis
	D. Hypereosinophilic syndrome

Image IQ: 50 year old man with nausea, vomiting, mental status change and rash 

This article was originally published on HCPLive.com.

In an effort to understand current trends in metabolic syndrome, a team of investigators provided an update on prevalence trends in the US from 2011-2016.

Robert Wong, MD, MS, and a colleague used data from the National Health and Nutrition Examination Survey to evaluate trends in metabolic syndrome prevalence among adults at least 20 years old. The survey data were cross-sectional, stratified, and a multistage probability sample of the US population taken from 2011-2016. The unweighted response rates ranged from 58.7-69.5%.

Metabolic syndrome was defined based on the National Cholesterol Education Program’s Adult Treatment Panel III. Patients needed to have at least 3 of the following: waist circumference greater than 102 cm in men or 88 cm in women, triglyceride level greater than 150 mg/dL, high-density lipoprotein cholesterol less than 40 mg/dL in men or less than 50 mg/dL in women, systolic blood pressure at least 130 mm Hg or diastolic blood pressure at least 85 mm Hg or taking hypertension medications, or fasting plasma glucose level at least 100 mg/dL or taking diabetes medications.

Wong and the team used weighted data to estimate the unadjusted prevalence of metabolic syndrome. They stratified the data by age group (20-39, 40-59, and at least 60 years old), sex, and race and ethnicity.

There were 17,048 total participants. The weighted metabolic syndrome prevalence was 34.7% (95% CI, 33.1-36.3). Prevalence was not significantly different among men and women (35.1% vs 34.3%; 

=.47) and was highest among “other” race/ethnicity (39%), followed by Hispanic (36.3%) and non-Hispanic white (36%) participants.

There was an increase in the overall crude metabolic syndrome prevalence from 2011-2012 to 2015-2016, but it did not meet statistical significance (from 32.5% [95% CI, 29-36.2] in 2011-2012 to 36.9% [95% CI, 33.9-39.9) in 2015-2016; 

=.07). Metabolic syndrome prevalence increased significantly among those in the youngest age cohort (20-39 years old) from 16.2% to 21.3% (

=.04), for Asian participants (from 19.9% to 26.2%; 

=.008), and Hispanic participants (from 32.9% to 40.4%; 

=.01).

There was a significant increase in prevalence with increasing age among all groups. The prevalence was 19.5% among those 20-39 years old and it increased to 48.6% among those at least 60 years old. There were no significant differences in metabolic syndrome prevalence between men and women in any age group. However, there were significant differences in prevalence among races/ethnicities for each age group. The highest prevalence was among participants who indicated “other” race/ethnicity who were at least 60 years old (64%), followed by Hispanic participants at least 60 years old (57.3%).

While the investigative team found the overall increase in prevalence did not meet statistical significance, there was a significant increase among young adults, and prevalence remained high for those at least 60 years old. The team noted the importance of implementing prevention strategies, including lifestyle modification and the use of medications targeted at those at the highest risk.

The study, “

Trends in the Prevalence of Metabolic Syndrome in the United States, 2011-2016

Although the investigative team found the overall increase in prevalence did not meet statistical significance, there was a significant increase among young adults, and prevalence remained high for those at least 60 years old. 

Prevalence of Metabolic Syndrome Among Young Adults on the Rise

An 18-year-old freshman college student was brought to the ED by 2 dormmates because she wasn’t acting like herself. They reported that she had been very stressed as her first papers were due in a few classes. They had also just gone to several campus parties and been drinking the weekend before. The patient told them it was her first time doing much drinking and she’d been drunk, but her friends had made sure she didn’t overdo it. The patient complained of abdominal pain and nausea and had vomited in the car on the way to the hospital. Her dormmates knew she hadn’t had diarrhea because she’d actually been complaining to them earlier that she felt constipated. She seemed agitated, but also exhibited weakness in her extremities, needing help to move around. The doctor noted tachycardia and dark urine output.

Image IQ: 18-Year-Old With Abdominal Pain, Nausea, and Weakness

 to read more from HCPLive's "Sudden Future" feature series. 

If you ask 10 doctors about their electronic health record (EHR) system, you might get 10 answers as to why they are a problem.

The one constant, however, would be that there are problems. And few things are stressed more by users than that the devices, designed to help streamline clinical data logging and access, take up valuable time and ultimately contribute to physician burnout.

A group of physicians from the Saint Louis University School of Medicine have taken the matter of realizing the streamline aspirations of EHR platforms to task: they created the means to have their institution-used system automatically populate necessary forms, reducing the time spent searching through the record system endlessly for the right set of notes.

Alexis McKee, MD, Endocrinology Diabetes & Metabolism, Internal Medicine, Chris Sallie, MD, Hospitalist, Pediatrics, Pediatrics, and Mark Eddy, MD, Pediatric Endocrinology, Pediatrics, explained in an interview with HCPLive® how tweaking their EHR system they were able to achieve big success.



The basis of the Saint Louis model is that the researchers are taking advantage of what the EHR already knows. To start, it knows the patient’s age and why they are visiting the doctor; this alone provides the doctor with all the appropriate forms needed automatically without a lengthy search through the system.

One of the main EHR complaints that McKee and Sallie have heard from their colleagues is that they are required to find the note name themselves.

“So, we tried to eliminate a lot of those steps to say, ‘I'm just going to bring you the appropriate thing for you to fill this out,’” Sallie said.

This stressor grew more apparent in March, as the coronavirus disease 2019 (COVID-19) pandemic began to ramp up, pushing many medical appointments to a virtual setting.

With the switch to telemedicine, doctors across the country were forced to use brand new forms when filing records following an appointment.

However, the EHR used by McKee’s group automatically populated the necessary consent and other forms needed for a telehealth visit.

Sallee explained how it took less than an hour to initially implement the new setting into the system, ultimately saving each doctor time on the backend.

The platform used by Missouri-based physicians is provided by Epic, provider of record-keeping systems for more than 50% of doctors across the country.

The doctors are using a program offered by Epic called Physician Builder, which allows providers to become amateur program developers to specify what they need to streamline their individual practices.

“What Chris, Mark, and I have learned to do, by going up and taking these Physician Builders courses is to manipulate the health record to work exactly the way we want it to work,” McKee said. “So, it's this intersection between tech, medicine, academic science, all coming together to improve quality of care and efficiency.”

What made the team’s use of this free application on the most popular EHR system in the country stand out, though, is its adoption in treating what was very recently the greatest public health concern in the US.

The Saint Louis doctors are now able to use their platform in alignment with the most recent guidelines and clinical research from the American Diabetes Association (ADA).

“If your patient has diabetes and heart failure you should be looking at an SGLT2 inhibitor unless they have contract indications X, Y, and Z,” McKee said. “And then that could just populate without doing anything.”

Implementing data-driven programs is not always easy, though.

“I think the problem is that diabetes is just a data-dense subspecialty,” Eddy said. “Trying to get the information into a node that we can bill and get our work done is a difficult endeavor with sort of the system that we have.”

While the system has had an impact on patient care, the doctors do have plans to upgrade the platform. Ultimately, they’d like to implement a “plug and play” model that would automatically upgrade the EHR’s data as new information is released by the ADA and other medical associations.

Even without the automatic updates, the new EHR has had an impact on Sallee’s clinic.

The endocrinologist said his clinic saw 10,700 patients in 2010 prior to implementing the streamlines platform. That number skyrocketed last year to more than 23,000 patients, without any significant increases in providers or space.

And yet, the time from when the patient signs in to when the notes are completed decreased by 91%.

The burnout problem could be alleviated by utilizing new technology to improve EHRs.

“Because if you have some stake in the game, you have some control over doing things, you're always going to feel better,” McKee said. “The definition of stress having no control over your environment. So, when you have this like terrible EHR, that you're spending your nights filling in this like crappy way. It's definitely frustrating.”

Whereas, he countered, if a physician felt as if they had more control over the EHR, it becomes the tool they always envisioned it to be. Burnout becomes benefit.


While the constant updates to guidelines and new clinical trials are daunting for medical professionals to learn, they make it nearly impossible for patients to learn about their treatments and conditions.

However, much like a streamlined EHR can aid doctors in improving patient care, online learning tools can help patients navigate text and clinical jargon and become better informed about treatment options.

Match Health Academy recently created a new set of online classes aimed at improving patient knowledge. In an interview with 

, Kavita Bouknight, founder and chief executive officer of Match Health Academy, explained the basis for the new health classes.

“It's essentially an online learning platform, which helps consumers better understand their health conditions, or that of loved ones,” she said. “And especially if you have little to no background in medicine, navigating through text and reading clinical lingo can really be overwhelming and often confusing.”

The new courses include comprehensive video courses where consumers can “take control” of their condition by using a combination of 3D animations and visual analogies to help break down more complex concepts to help make it easier to understand.

The program also includes all the different type of treatment options available for each patient.

Each video course is between 25-35 video modules with each module no more than 2 minutes long on average.

Bouknight said the project was in the works prior to the COVID-19 pandemic, but the developers sped up the project once the pandemic began. They also included a larger focus on respiratory conditions, with the first courses focusing on asthma, COPD, and sleep apnea.

The videos could aid doctors as well as patients.

“A lot of times not all physicians are going to be aware of all of the different treatment options depending on their specialty. And so, what we do is that we curate the different types of medical innovations that are available for a particular condition,” Bouknight said.

One of the reasons the new platform is necessary is there has been major advancements in medical research in recent years with more and more treatment options becoming available. With that said, the majority of the long-standing older treatments still can be effective for patients.

Along with pharmacological options, this platform also includes new technologies that come to market that could help treat various disease. For example, recently there has been a few sleep apnea technologies made available that go beyond CPAP machines.

“There's new advancements happening every day,” Bouknight said. “And that's the purpose of one of the purposes of our platform is to give consumers everything they need to know in one place, because it's incredibly difficult as a consumer to even know what to look for.”

Many tools are becoming available to physicians who need to strengthen their reach of care outside the office.

Sudden Future: Streamlined EHR Could Help Drive Better Patient Care

A weekly growth hormone injection could replace daily injections in children with growth hormone deficiencies.

A team, led by Aristides K. Maniatis, MD, Rocky Mountain Pediatric Endocrinology, evaluated children with growth hormone deficiency of a broad range of baseline demographics and treatment durations, who switched from daily injection therapies to once-weekly TransCon human growth hormone (hGH).

Maniatis explained in a presentation for the ENDO Online 2020 virtual conference that poor adherence is a major issue with the daily growth hormone regimen, with two-thirds of patients missing at least 1 injection per week.

TransCon hGH is an investigational long-acting prodrug consisting of hGH, an inert carrier that protects it, and a linker that temporarily binds the other 2 components. The unmodified treatment is gradually released in a predictable manner when inject into the body and physiologic pH and temperature.

In the study, all subjects initiated open-label once-weekly TransCon hGH 0.24 mg hGH/kg/week regardless of prior daily dosages. The 164 participants in the trial were between 3-17 years old who were previously either treatment-naïve or treated with daily hGH for ≤130 weeks. The mean age at baseline was 10.6 years old, with 97.9% of the participants coming off of a prior daily regimen of 0.29 mg/kg/week, with only 3 participants going in treatment naïve.

More than half of the subjects (56.8%) experienced a treatment-emergent adverse event, but only 4.1% experiencing an adverse event related to the study drug.

The investigators sought primary objectives of assessing the safety and tolerability over the course of 26 weeks. They included efficacy measures of annualized height velocity (AHV), height standard deviation scores (SDS), and insulin-like growth factor 1 (IGF-1) SDS.

The mean hemoglobin a1c remained 5.2% at baseline and week 26, while no neutralizing antibodies were detected.

Low-titer anti-hGH binding antibodies were found in 2.8% of the subjects. The growth outcomes were found as expected for the treatment-experienced heterogenous population, with a least-squares mean LSM) AHV of 8.7 cm/year (95% CI: 8.2, 9.2) at week 26 and LSM height SDS change from baseline to Week 26 of +0.25 (95% CI: 0.21, 0.29).

In the age-defined subgroups, the mean observed AHV at the conclusion of the trial ranged from 8.2-16.2 cm/year, while the mean observed height SDS change from baseline to week 26 ranged from +0.23 to +0.96.

The investigators also discovered the linear relationship between average IGF-1 SDS and TransCon hGH doses in previous treatment-naïve trials was preserved in the sample of treatment-experienced children who had dose titrations.

The investigators sought primary objectives of assessing the safety and tolerability over the course of 26 weeks. They included efficacy measures of annualized height velocity (AHV), height standard deviation scores (SDS), and insulin-like growth factor 1 (IGF-1) SDS.

“TransCon hGH treatment outcomes, including AHV and height SDS, were as expected across a diversity of ages, disease characteristics, and treatment experiences, reflective of a real-world setting,” the authors wrote. “Dose titrations of TransCon hGH demonstrated a predictable IGF-1 response. Switching to TransCon hGH resulted in a similar adverse event profile to daily hGH therapy.”

The investigators administered a questionnaire to the patients in the trial and found 83% of children and 88% of parents preferred the new treatment because of decreased frequency of injections.

The study, “

OR10-05 Phase 3 FliGHt Trial: Experience of Switching from Daily Growth Hormone Therapy to Once-Weekly TransCon HGH in Children with Growth Hormone Deficiency

A weekly growth hormone injection could replace daily injections in children with growth hormone deficiencies.

Weekly TransCon Hormone Injections Could Replace Daily Therapy

 was originally published on HCPLive.com.

Findings of recent research demonstrate an intervention program, Balance after Baby, is promising for decreasing diabetes risk factors in women with recent gestational diabetes.

The findings were presented as part of the American Diabetes Association’s (ADA’s) 80th Virtual Scientific Sessions.

Gestational diabetes complicates 3-7% of pregnancies, and the number is growing, Jacinda Nicklas, MD, MPH, MA, said during a presentation of her investigative team’s data and findings. What’s more, 30-70% of women with gestational diabetes develop type 2 diabetes within 10 years, and those with a history of gestational diabetes are more likely to retain and even gain weight postpartum. Obesity and weight gain are the strongest modifiable risk factors for type 2 diabetes.

Previous research found among women with a self-reported history of gestational diabetes in the Diabetes Prevention Program, those randomized to an intensive lifestyle program had a 53% risk reduction for type 2 diabetes.

Nicklas and a team of investigators adapted the Diabetes Prevention Program to help women overcome postpartum barriers through a web-based delivery intervention and remote coaching called Balance after Baby. As a pilot trial, the team conducted a randomized controlled trial at Brigham and Women’s Hospital of women with recent gestational diabetes from 6 week-12 months postpartum. The primary outcome was weight loss at 12 months from six-week weight and from pre-pregnancy weight.

The investigators noticed a significant change in weight for those randomized to the intervention (n=75 women). When the team looked from 6 weeks to 12 months, the control group gained almost 1 pound while the intervention group lost nearly 6 pounds (

=.0224).

There was also a difference in postpartum weight retention at 12 months. Women in the control group gained about 10 pounds while those in the intervention group lost slightly more than 1 pound (

=.0349).

Due to the success of the pilot trial, the investigators launched a more diverse study at 2 sites, 1 in Massachusetts and 1 in Colorado.

In total, 181 women were enrolled. The study population was enriched with Hispanic and low-income women. Women included met gestational diabetes criteria or had a clinician diagnosis, were 

45 years old, and had a BMI at randomization of 

24 kg/m2. The intervention was delivered in both English and Spanish. Participants were randomized to either the Balance after Baby intervention or the control group. Those in the control group had access to a website with knowledge links about how to prevent type 2 diabetes.

For the intervention, women were asked to complete a module every week for the first 12 weeks, with bonus modules available thereafter. The website had places for tracking weight and steps, an area to complete action plans, a place to contact their lifestyle coach, and a community forum to interact with other participants.

The primary outcomes were weight loss at 12 months from 6 weeks postpartum and weight loss at 12 months from pre-pregnancy weight. There was an additional outcome to assess weight at 24 months, however, governmental regulatory delays caused the study to stop early, Nicklas said during the presentation.

Overall, for change in weight from 6 weeks to 12 months, the control group gained 1.3 pounds, while the intervention group lost 1.8 pounds (difference, 3.1 pounds; 

=.09). When the team looked at weight retention at 12 months from pre-pregnancy weight, the control group gained 10.1 pounds while the intervention group gained 5.3 pounds (difference, 4.8 pounds; 

=.04). The intervention was ineffective for Hispanic women, which was backed by the literature of low-income Hispanic women being less likely to engage in interventions and being twice as likely to experience significant postpartum weight retention versus White non-Hispanic women.

“The web-based Balance after Baby, through its effect on postpartum weight retention, has potential to delay or prevent development of type 2 diabetes in postpartum women with recent (gestational diabetes),” Nicklas concluded.

The study, “

A Web-based Lifestyle Intervention To Reduce Postpartum Weight Retention In Women With Recent Gestational Diabetes: The Balance After Baby Intervention Trial

Findings of recent research demonstrate an intervention program, Balance after Baby, is promising for decreasing diabetes risk factors in women with recent gestational diabetes.