eSource Data in Clinical Investigations Meeting – May 2-3, 2016

 

Another must meeting: eSource Data in Clinical Investigations May 2-3, 2016, Wyndham Philadelphia Historic District, Philadelphia, PA. This meeting will focus on industry models for implementation, streamlined data processes and change management to enable eSource adoption. For a discount on the registration fee, use the Promo Code UNJ227.

 

Our friend and colleague Imogene Dunn, PhD will present on the topic: “Build Consensus and Acceptance for eSource Implementation.“ She will address the concept that while leveraging technological advancements has been widely accepted in theory, transforming the theory into practice requires buy-in, first, with the clinical development team, and secondly, with the site personnel who actually use the tools.

 

Jules Mitchel, PhD, President of Target Health will present on the topic “Gaining Critical Insight into the First FDA Product Approval Where Direct Data Entry Occurred at the Time of the Clinic Visit. The presentation will use results and experiences during the clinical development of an FDA-granted de novo 510(k) device, and will take a deep-dive into the processes that were used, including how to:

 

1. Involve regulators as partners

2. Educate and train the clinical research sites

3. Integrate eSource processes with risk-based monitoring

4. Evaluate the impact on the clinical research enterprise

 

And finally, Dr. Mitchel will join Leonard Chuck, Ph.D., M.D., Medical Director, Diablo Clinical Research and Erica Lawson, Senior Manager, Clinical Management, Otsuka Pharmaceutical Development and Commercialization on a panel addressing “How to Streamline the eSource Workflow.“ Topics will include assessing what each key stakeholder faces that causes disruption within the workflow process, examining the challenges with the workflow process at the sites and between monitoring and data management, and how do one helps to take these people out of their silos and work together.

 

Springtime in NY

 

 

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Spring is here! Ducks Doing Their Thing in Central Park ©Target Health Inc. 2016

 

ON TARGET is the newsletter of Target Health Inc., a NYC – based, full – service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.

 

For more information about Target Health contact Warren Pearlson (212 – 681 – 2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

QUIZ

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Climate Change and Public Health

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2015 – Warmest Global Year on Record (since 1880) – Colors indicate temperature anomalies (NASA/NOAA; 20 January 2016); NASA Scientific Visualization StudioGoddard Space Flight Center

 

Meetings in Davos this year 2016, focused attendees on a Fourth Industrial Revolution, the previous ones outstripping our planet’s ability to sustain itself, consuming and dumping millions of tons of fossil 1) ___ into our fragile ecosystem. This Fourth Industrial Revolution, would supposedly bring shared abundance for all global citizens. The looming catastrophe, lurking in the background of all endeavors, is climate change. And, will there even be a viable world left, due to the hellish ravages of global destruction, due to the nightmare-ish examples that we see each week, around the planet. Man-made greenhouse gas emissions have increased since the pre-industrial era, driven largely by our economic and population growth. This has led to the highest atmospheric concentrations of carbon dioxide, 2) ___ and nitrous oxide in at least the last 800,000 years.

 

 

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Source: IPCC

 

Several reports published by the Intergovernmental Panel for Climate Change (IPCC) have, year after year, demonstrated successive record breaking events across a range of geological parameters. In the last century, the world has warmed by approximately 0.75 degrees Celsius, with each of the last three decades being successively warmer than any preceding decade since 1850. Since the beginning of the industrial era, oceanic uptake of carbon dioxide has resulted in its acidification; with a 0.1 pH decrease of ocean surface water corresponding to a 26% increase in acidity. 3) ___ warming has dominated the increase in energy stored in the climate system, accounting for more than 90% of the energy accumulated between 1971-2010. The annual mean sea-ice extent has been reducing at a rate of 3.5-4.1% per decade in the Arctic and 1.2-1.8% per decade in the Antarctic. Arctic sea-ice extent has decreased in every season and in every successive decade since 1979. Over the period 1901 to 2010, the global mean sea level has risen by an average of 19 centimeters.

 

 

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Source: IPCC

 

If we don’t act now, in 2016, current levels of greenhouse 4) ___ emissions will continue, causing further warming and long-lasting changes in all components of the climate system, increasing the likelihood of severe, pervasive and irreversible impacts for people and ecosystems, with uneven distributions, generally greater for disadvantaged people and communities. Many very intelligent, but ill-informed regarding climate change, people view climate change as a geographic and physical phenomenon, but thinking like this is not even reaching the tip of the iceberg (sorry for the unfortunate pun). Climate change is an extremely serious, real human and biological event, speeding forward, with a host of related public health issues. If left unchecked, global warming will cause hundreds of millions of deaths across the world in this and coming decades (decades, not centuries). Some scientists think we might not even make it to the year 2100 and that the species, homo sapiens could become extinct. According to the World Health Organization, taking into account only a subset of the possible health impacts, and assuming continued economic growth and progress in public health, climate change is expected to cause approximately 250,000 additional deaths per year between 2030 to 2050; 38,000 due to heat exposure in the elderly; 48,000 due to diarrhea; 60,000 due to malaria; and 95,000 due to malnutrition in children. These figures are probably low. This does not include the immeasurable deaths that will occur due to extreme climate events (flooding, tornedoes, wildfires, droughts, earthquakes, etc.) and forced migration. Broadly speaking, the effects on our health can be divided into four main categories.

 

1. Heat stroke and cardiovascular disease

Extreme weather events will affect rates of cardiovascular diseases (CVD) in several ways. Directly, the stress of an extreme event or anxiety over its recurrence is associated with increased 5) ___ infarctions (or heart attack) and sudden cardiac death. Indirectly, the displacement caused by a disaster is frequently associated with interruptions of medical services putting populations with chronic conditions at risk. Cities and urban sprawl are more exposed to this risk due to the ?Urban Heat Island’ (UHI) effect. High concentrations of buildings cause the generation and absorption of heat, making the urban center as much as 3-5 degrees Celsius warmer than surrounding areas. This places added strain on the temperature regulating components of the body, principal of which are vasculature tone and body fluid content, influencing 6) ___ pressure control, cardiac output through fluid redistribution and kidney function. Prolonged exposure can cause heat cramps and exhaustion leading to heat stroke and death; exacerbating pre-existing chronic conditions such as various cerebral and cardiovascular diseases, particularly in the elderly and frail. In the absence of any adaptation of the population, modeling done by the London School of Hygiene & Tropical Medicine has reported that heat-related deaths would be expected to rise by around 257% by the 2050s from its current annual baseline in the UK as a surrogate for the developed world. An international study conducted in China, meanwhile, looked at population risk to CVD with changing temperature rather than just its rise. The study found those to be at the greatest risk were individuals who were subjected to fluctuating temperatures (both a rise and fall in ambient temperature), with cold effects lasting longer than hot effects.

 

2. Air pollutants and respiratory disorders

With a rise in air allergens, decrease in air quality and rising ozone levels, respiratory conditions – which already affect 334 million people with asthma globally and 210 million people with Chronic Obstructive Pulmonary Disease (COPD) – will be exacerbated. Climate change has the potential to impact airway diseases by increasing ground level ozone and fine particle concentrations in the air. Air pollution is able to overcome the mucosal barrier in the lungs by inducing airway inflammation, resulting in allergen-induced respiratory responses. In addition, air pollutants fewer than 2.5 micrometers in diameter (PM2.5) and ozone may alter the allergenicity of aeroallergens like pollen, thereby promoting further airway sensitization. These microscopic droplets lodge deep into 7) ___ tissue, causing serious health problems. Inhaling them triggers a variety of reactions including chest pain, coughing, throat irritation, and congestion; and worsens allergies, bronchitis and emphysema, by reducing lung function and inflaming the linings of the lungs – repeated exposure of which can permanently scar lung tissue. A study by the European Respiratory Society estimated that there would be 1,500 more annual ozone associated deaths by the year 2020 in the UK alone.

 

3. Vector-born and zoonotic diseases (VBZD)

VBZDs are 8) ___ diseases, the transmission of which involves either animal hosts or vectors serving as zoonotic reservoirs for human pathogens or as a means in which they move between species. We are seeing an increasing emergence in zoonotic disease outbreaks with the majority of recent major human infectious disease outbreaks worldwide such as SARS, MERS and HIV/AIDS, originating in animals. The link between malaria and extreme climatic events has long been studied. In India, excessive monsoon rainfall and high humidity has been identified to enhance mosquito breeding and survival. Recent analyses have also shown that the malaria epidemic risk increases five-fold in the year immediately after an El Nino event. The use of a meteorological model and biological data regarding the brown dog tick, Rhipicephalus sanguineus, clearly indicates the climatic zone favorable for this tick species reproduction has expanded by 669% since the 1960s in Europe alone. By observing the activity of such tick vectors, over relatively short periods of time, provides evidence towards this growing problem. The same being true of other vectors like sandflies, mosquitoes, fleas, larvae, worms, insects, snails or other cold-blooded animals. Clearly, there will be a global rise in disease due to more favorable conditions brought about by climate change.

 

4. Malnutrition through food and water, as well as toxicity

According to the United Nations Development Program, some 3.7 billion people worldwide are currently malnourished. Extreme weather events and changes in temperature and precipitation patterns will directly damage or destroy crops and other food supplies, as well as interrupt transportation chains. Indirectly, there is potential for harm and sickness, from 9) ___ resulting from damage to agricultural crops and related trade, economic, and social instability; diversion of staple crops for use in biofuels, impaired ability to grow crops due to changing environmental conditions and water availability; and the reduced availability and nutritional quality of protein from fisheries, aquaculture, and other marine-based foods. Food and water can also be a source of exposure to illnesses, resulting from the ingestion of microbes, chemical residues (such as pesticides, biotoxins) or other toxic substances. With a rise in the number of natural disasters and changing weather patterns, there will be a reduction in the supply of fresh drinking 10) ___. The WHO already estimates there are approximately 760,000 child deaths annually due to diarrheal diseases, and this huge number will only be compounded by the rise in floods, droughts and famines that climate change will bring.

 

The people of the world expressed some hope, this past December 2015, in Paris, as 157 world leaders along with 40,000 delegates from 196 countries, came together to craft a legally binding climate accord, which could once and for all address the impact of climate change on our planet. It won’t be easy to achieve these goals; however, if we work together cooperating in order to survive, perhaps we can begin creating a remedial response to the damage of the last few centuries. This would mean a complete change from our current unsustainable way of life to adapting to a world in which we are not dependent on oil, coal or natural gas and where we live within our means.

 

Update summary of IPCC research on climate change

 

This video is a must see. It’s a compilation of well-known climate scientists, with top credentials, from around the world. If you disagree with what you hear, that’s fine, start a discussion, read more and come to your own conclusions, but don’t sit back and do nothing. If you do agree with the video above, go ahead and pass it on to others who haven’t had time to think about these issues.

 

You can either take action, or you can hang back and hope for a miracle. Miracles are great, but they are so unpredictable. (Peter F. Drucker)

 

ANSWERS: 1) fuels; 2) methane; 3) Ocean; 4) gas; 5) myocardial; 6) blood; 7) lung; 8) infectious; 9) malnutrition; 10) water

 

Public Health

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The primitive nature of medieval medicine rendered Europe helpless to the onslaught of the Black Death in the 14th century. Fragment of a miniature from “The Chronicles of Gilles Li Muisis“ (1272-1352). Bibliotheque royale de Belgique, MS 13076-77, f. 24v.

 

Public health has early roots in antiquity. From the beginnings of human civilization, it was recognized that polluted water and lack of proper waste disposal spread communicable diseases (theory of miasma). Early religions attempted to regulate behavior that specifically related to health, from types of food eaten, to regulating certain indulgent behaviors, such as drinking alcohol or sexual relations. Leaders were responsible for the health of their subjects to ensure social stability, prosperity, and maintain order. By Roman times, it was well understood that proper diversion of human waste was a necessary tenet of public health in urban areas. The ancient Chinese medical doctors developed the practice of variolation following a smallpox epidemic around 1000 BCE. An individual without the disease could gain some measure of immunity against it by inhaling the dried crusts that formed around lesions of infected individuals. Also, children were protected by inoculating a scratch on their forearms with the pus from a lesion.

 

In 1485 the Republic of Venice established a Permanent Court of supervisors of health with special attention to the prevention of the spread of epidemics in the territory from abroad. The three supervisors were initially appointed by the Venetian Senate. In 1537 it was assumed by the Grand Council, and in 1556 added two judges, with the task of control, on behalf of the Republic, the efforts of the supervisors. However, according to Michel Foucault, the plague model of governmentality was later controverted by the cholera model. A Cholera pandemic devastated Europe between 1829 and 1851, and was first fought by the use of what Foucault called “social medicine“, which focused on flux, circulation of air, location of cemeteries, etc. All those concerns, born of the miasma theory of disease, were mixed with urbanistic concerns for the management of populations, which Foucault designated as the concept of “biopower“. The German conceptualized this in the Polizeiwissenschaft (“Police science“). The 18th century saw rapid growth in voluntary hospitals in England. The latter part of the century brought the establishment of the basic pattern of improvements in public health over the next two centuries: a social evil was identified, private philanthropists brought attention to it, and changing public opinion led to government action.

 

 

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1802 caricature of Edward Jenner vaccinating patients who feared it would make them sprout cowlike appendages.

 

 

The practice of vaccination became prevalent in the 1800s, following the pioneering work of Edward Jenner in treating smallpox. James Lind’s discovery of the causes of scurvy amongst sailors and its mitigation via the introduction of fruit on lengthy voyages was published in 1754 and led to the adoption of this idea by the Royal Navy. Efforts were also made to promulgate health matters to the broader public; in 1752 the British physician Sir John Pringle published Observations on the Diseases of the Army in Camp and Garrison, in which he advocated for the importance of adequate ventilation in the military barracks and the provision of latrines for the soldiers. With the onset of the Industrial Revolution, living standards amongst the working population began to worsen, with cramped and unsanitary urban conditions. In the first four decades of the 19th century alone, London’s population doubled and even greater growth rates were recorded in the new industrial towns, such as Leeds and Manchester. This rapid urbanization exacerbated the spread of disease in the large housing complexes that built up around the workhouses and factories. These settlements were cramped and primitive with no organized sanitation. Disease was inevitable and its incubation in these areas was encouraged by the poor lifestyle of the inhabitants. Unavailable housing led to the rapid growth of slums and the per capita death rate began to rise alarmingly, almost doubling in Birmingham and Liverpool. Thomas Malthus warned of the dangers of overpopulation in 1798. His ideas, as well as those of Jeremy Bentham, became very influential in government circles in the early years of the 19th century.

 

 

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Sir Edwin Chadwick was a pivotal influence on the early public health campaign.

 

The first attempts at sanitary reform and the establishment of public health institutions were made in the 1840s. Thomas Southwood Smith, physician at the London Fever Hospital, began to write papers on the importance of public health, and was one of the first physicians brought in to give evidence before the Poor Law Commission in the 1830s, along with Neil Arnott and James Phillips Kay. Smith advised the government on the importance of quarantine and sanitary improvement for limiting the spread of infectious diseases such as cholera and yellow fever. The Poor Law Commission reported in 1838 that “the expenditures necessary to the adoption and maintenance of measures of prevention would ultimately amount to less than the cost of the disease now constantly engendered“. It recommended the implementation of large scale government engineering projects to alleviate the conditions that allowed for the propagation of disease. The Health of Towns Association was formed in Exeter on 11 December 1844, and vigorously campaigned for the development of public health in the United Kingdom. Its formation followed the 1843 establishment of the Health of Towns Commission, chaired by Sir Edwin Chadwick, which produced a series of reports on poor and insanitary conditions in British cities. These national and local movements led to the Public Health Act, finally passed in 1848. It aimed to improve the sanitary condition of towns and populous places in England and Wales by placing the supply of water, sewerage, drainage, cleansing and paving under a single local body with the General Board of Health as a central authority. The Act was passed by the Liberal government of Lord John Russell, in response to the urging of Edwin Chadwick. Chadwick’s seminal report on The Sanitary Condition of the Laboring Population was published in 1842 and was followed up with a supplementary report a year later.

 

Vaccination for various diseases was made compulsory in the United Kingdom in 1851, and by 1871 legislation required a comprehensive system of registration run by appointed vaccination officers. Further interventions were made by a series of subsequent Public Health Acts, notably the 1875 Act. Reforms included latrinization, the building of sewers, the regular collection of garbage followed by incineration or disposal in a landfill, the provision of clean water and the draining of standing water to prevent the breeding of mosquitoes. The Infectious Disease (Notification) Act 1889 mandated the reporting of infectious diseases to the local sanitary authority, which could then pursue measures such as the removal of the patient to hospital and the disinfection of homes and properties.

 

In the U.S., the first public health organization based on a state health department and local boards of health was founded in New York City in 1866. The science of epidemiology was founded by John Snow’s identification of a polluted public water well as the source of an 1854 cholera outbreak in London. Dr. Snow believed in the germ theory of disease as opposed to the prevailing miasma theory. He first publicized his theory in an essay, On the Mode of Communication of Cholera, in 1849, followed by a more detailed treatise in 1855 incorporating the results of his investigation of the role of the water supply in the Soho epidemic of 1854. By talking to local residents (with the help of Reverend Henry Whitehead), he identified the source of the outbreak as the public water pump on Broad Street (now Broadwick Street). Although Snow’s chemical and microscope examination of a water sample from the Broad Street pump did not conclusively prove its danger, his studies of the pattern of the disease were convincing enough to persuade the local council to disable the well pump by removing its handle. Snow later used a dot map to illustrate the cluster of cholera cases around the pump. He also used statistics to illustrate the connection between the quality of the water source and cholera cases. He showed that the Southwark and Vauxhall Waterworks Company was taking water from sewage-polluted sections of the Thames and delivering the water to homes, leading to an increased incidence of cholera. Snow’s study was a major event in the history of public health and geography. It is regarded as the founding event of the science of epidemiology.

 

With the pioneering work in bacteriology of French chemist Louis Pasteur and German scientist Robert Koch, methods for isolating the bacteria responsible for a given disease and vaccines for remedy were developed at the turn of the 20th century. British physician Ronald Ross identified the mosquito as the carrier of malaria and laid the foundations for combating the disease. Joseph Lister revolutionized surgery by the introduction of antiseptic surgery to eliminate infection. French epidemiologist Paul-Louis Simond proved that plague was carried by fleas on the back of rats, and the Americans Walter Reed and James Carroll, demonstrated that mosquitoes carry the virus responsible for yellow fever. With onset of the epidemiological transition and as the prevalence of infectious diseases decreased through the 20th century, public health began to put more focus on chronic diseases such as cancer and heart disease. Previous efforts in many developed countries had already led to dramatic reductions in the infant mortality rate using preventative methods. In Britain, the infant mortality rate fell from over 15% in 1870 to 7% by 1930.

 

 

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Seal of the United States Public Health Service

 

In the administration of the second president of the United States John Adams, the Congress authorized the creation of hospitals for mariners. As the U.S. expanded, the scope of the governmental health agency expanded.

 

 

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Public health nursing made available through child welfare services in U.S. (c. 1930s)

 

 

In the United States, public health worker Sara Josephine Baker, M.D. established many programs to help the poor in New York City keep their infants healthy, leading teams of nurses into the crowded neighborhoods of Hell’s Kitchen and teaching mothers how to dress, feed, and bathe their babies. Another key pioneer of public health in the U.S. was Lillian Wald, who founded the Henry Street Settlement house in New York. The Visiting Nurse Service of New York was a significant organization for bringing health care to the urban poor. Dramatic increases in average life span in the late 19th century and 20th century, is widely credited to public health achievements, such as vaccination programs and control of many infectious diseases including polio, diphtheria, yellow fever and smallpox; effective health and safety policies such as road traffic safety and occupational safety; improved family planning; tobacco control measures; and programs designed to decrease non-communicable diseases by acting on known risk factors such as a person’s background, lifestyle and environment. Another major public health improvement was the decline in the “urban penalty“ brought about by improvements in sanitation. These improvements included chlorination of drinking water, filtration and sewage treatment which led to the decline in deaths caused by infectious waterborne diseases such as cholera and intestinal diseases. The federal Office of Indian Affairs (OIA) operated a large-scale field nursing program. Field nurses targeted native women for health education, emphasizing personal hygiene and infant care and nutrition.

 

 

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Elena Arizmendi Mejia and volunteers of the Mexican Neutral White Cross, 1911

 

Public health issues were important for the Spanish empire during the colonial era. Epidemic disease was the main factor in the decline of indigenous populations in the era immediately following the sixteenth-century conquest era and was a problem during the colonial era. The Spanish crown took steps in eighteenth-century Mexico to bring in regulations to make populations healthier. In the late nineteenth century, Mexico was in the process of modernization, and public health issues were again tackled from a scientific point of view.  Even during the Mexican Revolution (1910-20), public health was an important concern, with a text on hygiene published in 1916. During the Mexican Revolution, feminist and trained nurse Elena Arizmendi Mejia founded the Neutral White Cross, treating wounded soldiers no matter for what faction they fought. In the post-revolutionary period after 1920, improved public health was a revolutionary goal of the Mexican government. Public health was important elsewhere in Latin America in consolidating state power and integrating marginalized populations into the nation-state. In Colombia, public health was a means for creating and implementing ideas of citizenship. In Bolivia, the push came after their 1952 revolution.

 

Eye Cells May Use Math to Detect Motion

 

NMDA receptors are proteins that generate electrical signals in response to the neurochemicals glutamate and glycine. When activated, they allow electrically charged ions to flow in and out of cells like water through an unlocked canal. In the early 1980s, studies in France and at the NIH showed that magnesium blocks the flow until the neuron is strongly activated and its electrical state rises above a certain voltage. This regulation is thought to be critical for certain types of learning and memory, and in amplifying signals in neurons.

 

Vision begins when light enters the eye and hits the retina, which lines the back of the eyeball. Neurons in the retina convert light into nerve signals which are then sent to the brain. Eyes constantly send bits of information to our brains where the information is assembled into objects we recognize. Along the way, a series of neurons in the eye uses electrical and chemical signals to relay the information. In a study of mice, reported online in the journal Neuron (3 March 2016). it was demonstrated how one type of neuron may do this to distinguish moving objects. The study suggests that the NMDA receptor may help neurons in the eye and the brain relay that information.

 

Using retinas isolated from mice, the study evaluated neurons called directionally selective retinal ganglion cells (DSGCs), which are known to fire and send signals to the brain in response to objects moving in specific directions across the eye. Electrical recordings showed that some of these cells fired when a bar of light passed across the retina from left to right, whereas others responded to light crossing in the opposite direction. Previous studies suggested these unique responses are controlled by incoming signals sent from neighboring cells at chemical communication points called synapses. In this study, it was discovered that the activity of NMDA receptors at one set of synapses may regulate whether DSGCs sent direction-sensitive information to the brain. Further experiments by examined how magnesium’s control of NMDA receptors may regulate the firing of DSGCs. To mimic realistic conditions, the authors passed bars of light across retinas while exposing them to various background lights. The results suggested that the variable magnesium block that ensured the cells consistently sent information to the brain in response to the passing bars of light despite the distracting incoming stream of signals generated by the background lights. The NMDA receptors did this by amplifying the cells’ responses to the bars in a process called multiplicative scaling.

 

Air Pollution Linked to Higher Risk of Preterm Birth for Mothers with Asthma

 

Preterm birth is a major public health problem affecting more than 1 in 10 infants born in the United States According to the CDCasthma is a lung disease that affects an estimated 9% of women of reproductive age in the United States. Maternal asthma is associated with a higher risk of pregnancy complications and health problems for infants.

 

According to a study published online in the Journal of Allergy and Clinical Immunology (1 March 2016), pregnant women with asthma may be at greater risk of preterm birth when exposed to high levels of certain traffic-related air pollutants. The study observed an increased risk associated with both ongoing and short-term exposure to nitrogen oxides and carbon monoxide, particularly when women were exposed to those pollutants just before conception and in early pregnancy. For example, an increase of 30 parts per billion in nitrogen oxide exposure in the three months prior to pregnancy increased preterm birth risk by nearly 30% for women with asthma, compared to 8% for women without asthma. Greater carbon monoxide exposure during the same period raised preterm birth risk by 12% for asthmatic women, but had no effect on preterm birth risk for non-asthmatics. The last six weeks of pregnancy was another critical window for women with asthma, according to the study. Exposure to high levels of particulate matter, very small particles of substances like acids, metals, and dust in the air, also was associated with higher preterm birth risk.

 

While prior studies have examined the effects of various air pollutants on preterm birth risk, the authors said that its study is the first to examine whether exposure to air pollution before conception might affect later pregnancy. The authors hypothesized that early exposure to air pollution may set off inflammation or other internal stresses that interfere with embryo implantation or placental development, and that those disruptions could lead to preterm delivery. The authors added that more research will help us to better understand the potential impact of air pollution in the months surrounding conception.”

 

For the study, data were analyzed from a national sample of 223,502 singleton pregnancies (pregnancies with a single fetus), delivered at 19 hospitals around the country from 2002 to 2008. Electronic medical records of the women included their asthma status and date of delivery. The authors matched that data with daily measures of air quality from the regions surrounding each of the hospitals to assess the potential effects of air pollution, week by week, on preterm birth risk. Six pollutants were studied and accounted for such factors as location, age, race and ethnicity, pre-pregnancy weight, smoking and alcohol use, and chronic maternal health conditions.

 

The authors hope that studies like this one will one day improve the care of pregnant women with asthma and reduce their risk for preterm birth. Meanwhile, people with asthma who are concerned about exposures to air pollution may want to limit their outdoor activity during periods when the air quality is forecast to be unhealthy for sensitive groups.  Air quality data are available from theEnvironmental Protection Agency.

 

New Device Senses Optimal Time to Check Patient’s Eye Pressure

 

Glaucoma is a leading cause of vision loss and affects an estimated 3 million Americans. Many patients have no symptoms until significant vision has been lost, and this loss is irreversible. Intraocular pressure (IOP) varies throughout the day and may not be abnormally high when the patient is at an eye care professional’s office having an eye exam. For example, it is common for IOP to increase during sleep when the patient is lying down. Elevated IOP is often associated with the optic nerve damage that is characteristic of glaucoma

 

The FDA has allowed marketing of a one-time use contact lens that may help practitioners identify the best time of day to measure a patient’s IOP. The Triggerfish has a sensor embedded in a soft silicone contact lens that detects tiny changes or fluctuations in an eye’s volume. The device is worn for a maximum of 24 hours, transmitting data wirelessly from the sensor to an adhesive antenna worn around the eye. A portable data recorder worn by the patient receives information from the antenna and can transfer the data via Bluetooth to the clinician’s computer, which shows the range of time during the day the pressure of the eye may be increasing. The device does not actually measure IOP, is not intended to be a diagnostic tool and is not used to correct vision.

 

The Triggerfish is indicated for use in adults age 22 and older under the direction and supervision of a health care professional. Clinical data supporting the marketing authorization of the Triggerfish included several studies of the safety and tolerability of the contact lenses and the effectiveness of the device measurement. The effectiveness of the device was demonstrated by showing an association between the Triggerfish device output and IOP fluctuation. The most common temporary side effects were pressure marks from the contact lens, ocular hyperemia (red eyes) and punctate keratitis (irritation of the cornea). The FDA reviewed the data for the Triggerfish through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.

 

The Triggerfish is manufactured by Sensimed AG of Lausanne, Switzerland.

 

Parmesan Zucchini Savory Pudding, Appetizer or Side

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A Spring holiday delight! You won’t believe how fabulous the flavor is! A warm and wonderful appetizer, that melts in your mouth. Mmmmm! ©Joyce Hays, Target Health Inc.

 

After much experimentation with the ingredients, I’m extremely pleased with how this zucchini pudding came out. ©Joyce Hays, Target Health Inc.

 

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Prediction: These won’t last long! ©Joyce Hays, Target Health Inc.

 

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This portion size, will make a nice veggie side dish with any fish, seafood or poultry. ©Joyce Hays, Target Health Inc.

 

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To cut this triangle shape, you have to wait for the zucchini pudding to cool down a bit, or it will not hold together well. ©Joyce Hays, Target Health Inc.

 

 

Ingredients

 

4 zucchini, don’t peel. Clean and slice very thinly

1 cup almond flour

1 large onion, finely chopped

1/2 cup Parmesan cheese, freshly grated

3 Tablespoons fresh parsley, chopped well

Pinch chili flakes

Pinch salt

1 container Tofutti (non-dairy, soy cream cheese)

1 teaspoon fresh oregano leaves, well chopped

Pinch black pepper

six fresh garlic cloves, finely chopped (not squeezed)

1 generous Tablespoon of white truffle oil

1/2 cup extra virgin olive oil

4 eggs, slightly beaten, with 2 Tablespoons almond milk

 

 

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Simple, fresh ingredients ©Joyce Hays, Target Health Inc.

 

 

Directions

 

Heat oven to 350oF. Grease bottom and sides of a square or rectangular pan.

 

 

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Slice the zucchini as thinly as you can, preferably with a mandolin. ©Joyce Hays, Target Health Inc.

 

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Chopping the onion and garlic at the same time. ©Joyce Hays, Target Health Inc.

 

In a mixing bowl, add the Tofutti, almond flour, onion, Parmesan, chopped parsley, all seasonings, all herbs, chopped garlic, olive oil.

 

 

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Chopping the parsley and oregano at the same time. ©Joyce Hays, Target Health Inc.

 

 Stir all ingredients together, very well, by hand, not electric beaters.

 

 

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All ingredients are stirred together, except for the eggs and the zucchini. ©Joyce Hays, Target Health Inc.

 

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Don’t forget to buy and include the truffle oil or truffle-flavored olive oil. ©Joyce Hays, Target Health Inc.

 

 

Next, slowly add the eggs, stir together so all ingredients are well combined. If this mixture is too dry, add 1 teaspoon of olive oil.

Still dry? Add some plain Greek yogurt, start with 1 teaspoon.

 

 

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Just added the whisked eggs to the mixing bowl. ©Joyce Hays, Target Health Inc.

 

 

Finally, add the zucchini last and stir it into all other ingredients. When everything is well mixed, pour into baking pan, spread it out.

 

 

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The zucchini slices are added last to the other ingredients in mixing bowl. Now mix them in, so that everything is well combined. ©Joyce Hays, Target Health Inc.

 

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About to pour into the baking pan. ©Joyce Hays, Target Health Inc.

 

 

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Going into the oven now. ©Joyce Hays, Target Health Inc.

 

 

Bake about 30 to 40 minutes, depending on your oven, or until golden brown. Keep your eye on the oven for the last 10 minutes, so you don’t get too much brown on top. Look at the photos; you want a golden to light brown, and then you’ll know they’re done.

 

 

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Just coming out of the oven. ©Joyce Hays, Target Health Inc.

 

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Cool a little before you start cutting. There’s a reason I decided to call them zucchini savory pudding. They will hold their shape better, if they cool down, but still warm. ©Joyce Hays, Target Health Inc.

 

 

Cut into 2-inch squares or for an elegant look, cut the squares diagonally (in half), so they look like triangles.

 

 

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For sure, I’ll be making these zucchini savory puddings again. The next time, I’m going to bake them in individual ramekins and serve them as a side dish. ©Joyce Hays, Target Health Inc.

 

 

So, here we are (above), starting out with chilled glasses of Sauvignon Blanc and the de-lish appetizer, warm, melt in your mouth, zucchini pudding. It was so-o good, we almost decided to eat this for the whole meal. Next, came a new green bean salad, that will be shared soon, and warm kale/mushroom patties with broccoli stuffed potatoes. For dessert our favorite jello cake with cool whip.

 

This weekend we saw a wonderful play by John Patrick Shanley, winner of numerous awards and author of Doubt. His new play is, Prodigal Son, starring the extremely talented young actor, Timothee Chalamet, who is headed for a brilliant career. This play and this actor, directed by Shanley, is what New York theater is all about. The production is at one of the theater clubs we contribute to, Manhattan Theater Club and runs until March 27th. If you love good theater and don’t know what to see, run to see this play, Prodigal Son, at Stage One (next to NY City Center) and you’ll be talking about it for a long time. We promise that you will NOT be disappointed.

 

Nearby is a good Greek restaurant, Molyvos, and legendary Carnegie Deli.

 

 

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We enjoyed one of our favorite chilled whites, Stag’s Leap Cellars, Sauvignon Blanc, this weekend.

 

 

From Our Table to Yours !

 

Bon Appetit!