new research offers proof

A new study on the Mediterranean diet offers the strongest proof yet that it’s associated with healthy brain aging

Adhering to the Mediterranean diet as one ages appears to reduce the risk of cognitive decline, finds yet another study —one scientists say provides the strongest proof yet of its benefits.

Researchers from the University of Barcelona in Spain followed nearly 850 French citizens over the age of 65 for more than a decade. Participants were split fairly evenly between women and men, and all were dementia-free at the start of the study. They monitored a panel of biomarkers—like healthy omega-3 fatty acids EPA and DHA, found in foods consumed on the diet—every few years and performed five neuropsychological evaluations on each participant during the course of the study.

Those who closely followed the plant-based diet, rich in healthy fats—as evidenced by results of blood tests, not participant-completed food diaries or questionnaires—were less likely to experience cognitive decline as they aged.

Previous studies have examined the relationship between the diet and cognitive decline and produced mixed results, perhaps because participants didn’t accurately recall and/or report what they ate, researchers hypothesized. That’s why they opted to monitor diet adherence with biomarkers—an objective, versus subjective, approach.

The new research is “a step forward towards the use of more accurate dietary assessment methodologies,” Mercè Pallàs, professor of pharmacology at the university’s Neurosciences Institute, said in a news release about the findings, published in October in Molecular Nutrition & Food Research .

The study indeed “echoes previous studies that have shown that following a Mediterranean style diet is associated with healthy brain aging,” Caroline Susie , a registered dietitian, tells Fortune. “While there is no proven way to prevent dementia and cognitive decline, following this diet is associated with lower risk of cognitive decline.”

What is the Mediterranean diet?

This plant-based way of eating—with roots in ancient Roman and Greek tradition and the cuisine of the Middle Ages—was studied and solidified in the 1950s. It focuses on consuming a variety of healthy foods , including:

• Whole grains
• Extra virgin olive oil, a healthy fat
• Herbs and spices (in lieu of salt)

The following foods are allowed in low to moderate amounts:

• Fish, which contain healthy omega-3 fatty acids
• Wine with meals (if you don’t drink, don’t start)

The following foods are to be avoided:

• Red, fatty, and/or processed meats
• Highly processed foods
• Refined carbohydrates
• Saturated fats
• Sugary drinks

While dubbed a “diet,” it focuses on general guidelines as opposed to a strict method of eating and should be accompanied by daily physical exercise. Sharing meals with family and friends is also encouraged.

Those who choose to go Mediterranean should “opt for fruits, vegetables, nuts, seeds, olive oil, beans, whole grains, and olive oil,” Susie says. They should also aim for two servings of fish per week, and to keep active.

What are the benefits of a Mediterranean diet?

In addition to apparently lowering the risk of cognitive decline with age, the diet offers a wide variety of health benefits, including:

• Lowering the risk of heart disease, metabolic syndrome, and some cancers
• Supporting healthy body weight, blood sugar, blood pressure, and cholesterol
• Balancing gut microbiota
• Increasing life expectancy

That’s because of its numerous healthy aspects, including:

• Limited saturated and trans fats
• Limited sodium
• Limited sugar
• Increased healthy unsaturated fats
• Increased fiber and antioxidants

Micronutrients are ‘strikingly lower’ in Alzheimer’s brains

Levels of five micronutrients often found in Mediterranean diet foods are “strikingly lower” in the brains of those who have Alzheimer’s disease, compared with those who don’t, according to a study published this fall that analyzed the brains of 31 donors, the average age of which was 75 years. 

Most, but not all, had died with Alzheimer’s disease. Compared with unaffected brains, the researchers found that brains of those with the disease had around half the level of the following micronutrients—vitamins and minerals critical to the body’s function, but needed in only small amounts:

•  Lycopene : An antioxidant that could help protect cells from damage, lycopene gives some fruits and vegetables—like tomatoes, watermelon, red oranges, pink grapefruits, apricots, and guavas—their red hue.

• Retinol : A form of Vitamin A that helps the immune system work properly, retinol helps you see in dim lighting and keeps skin healthy. It’s found in foods like cheese, eggs, oily fish, milk, yogurt, and liver. Indirect sources include yellow, red, and green leafy vegetables like spinach, carrots, sweet potatoes, and red peppers, in addition to yellow fruits like mangoes, papaya, and apricots.

• Lutein : Often referred to as the “eye vitamin,” lutein is thought to protect eye tissue from sun damage. You can find it in foods like egg yolks, spinach, kale, corn, orange peppers, kiwis, grapes, zucchinis, and squash.

• Zeaxanthin : An antioxidant, zeaxanthin is known to protect eye tissues from the sun. It’s found in eggs, oranges, grapes, corn, goji berries, mangoes, and orange peppers.

• Vitamin E : Also an antioxidant, Vitamin E keeps free radicals in check, improves immune function, and can prevent clots from forming in the arteries of the heart. It can be found in plant-based oils, nuts, seeds, fruits, and vegetables like sunflower oil, soybean oil, almonds, peanuts, spinach, pumpkin, red bell peppers, asparagus, mangoes, and avocados. 

Multiple studies have also found that those who follow MIND (Mediterranean/ Dietary Approaches to Stop Hypertension Diet Intervention for Neurodegenerative Delay)—which emphasizes the consumption of antioxidant-rich fruits, vegetables, legumes, nuts, and fish with very little meat, dairy, and sweets—had a lower risk of developing Alzheimer’s disease, better cognitive function prior to death, and fewer signs of Alzheimer’s disease in those who did develop the condition.

“This study, for the first time, demonstrates deficits in important dietary antioxidants in Alzheimer’s brains,” Virginia Tech Carilion School of Medicine professor C. Kathleen Dorey said at the time, in a news release about the study .

“We believe eating carotenoid-rich diets will help keep brains in top condition at all ages,” she added.

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No more Fridays

A real-world experiment just proved that we should all shift to a four-day workweek

The results are in: It's time for your company to stop working on Fridays (or Mondays).

The latest, perhaps most convincing evidence yet for the shift to a four-day workweek comes from a six-month trial which began in February 2022 in which 33 companies with employees in six countries decreased their employees' workload to four days, or 32 hours, a week. Organized by 4 Day Week Global, the real-world experiment sought to see whether the employees could be just as productive in 80% of the time — all for the same pay. The results were overwhelmingly positive: Companies in the program reported increased revenue and improved employee health and well-being, and had a positive impact on the environment. And after the success, a hundred more companies that together employ thousands of people are considering or are already implementing the same approach.

So if you've ever tried to persuade your boss to shift to a four-day workweek, this is the best evidence yet that it can work. The results of the new report were unequivocal: The four-day workweek was better for everyone.

'It probably sounds crazy, but it works' 

At the outset of the trial, employees at Soothing Solutions, a Dundalk, Ireland-based company that makes cough lozenges for children, were skeptical that a four-day working week would be feasible, let alone profitable. But the founders Sinéad Crowther and Denise Lauaki had high hopes. When the company was founded in 2017, the duo wanted to establish a people-focused culture, so when Crowther learned about 4 Day Week's program in 2021, she saw it as a way to attract and retain talent.

Since Soothing Solutions hired its first employees last year, no staff members have left the company, and Crowther told me the anecdotal feedback about the four-day week had been so glowing that it almost moved her to tears. "One of our employees has an elderly parent who was terminally ill, and she got to spend three, four days a week with them," she told me. "She said nothing can give her that time back. She wouldn't have got to do that in any other job." Another worker has been able to pursue her passion for photography in her time off, Crowther said, adding that "it turns out, she's a fantastic photographer!"

Because Soothing Solutions started operations using the four-day week, the founders don't have anything to compare their business growth to, but Crowther isn't worried about any negative impact a four-day week might have on business, even as the company grows. When we spoke, Soothing Solutions had just launched on Amazon and had its first UK sale. Its products are available in Ireland, Northern Ireland, Cyprus, and Scotland, with plans to expand further. "We have absolutely no concerns," she said. "It probably sounds crazy, but it works."

4 Day Week Global is a nonprofit community platform that promotes the four-day workweek by helping companies implement it and by funding research into the future of work. The organization was established after the success of a landmark trial program at its cofounder Andrew Barnes' New Zealand company Perpetual Guardian . To conduct trials at companies and analyze their results, the group has partnered with academics at Harvard Business School, Oxford University, and the University of Pennsylvania.

The four-day-week movement has been gaining momentum on the heels of the Great Resignation and the push from employees to rethink the way we work. The tech startup Bolt became the first unicorn to trial it in 2021, finding it so successful that it implemented it after three months. Other trials of shorter weeks have found success as well: A 2021 trial in Iceland found positive results, and a 2019 research paper by Henley Business School found that two-thirds of businesses operating on a four-day week saw employee productivity increase. 

There is some pushback , though. A shorter week could mean employees' workload increases each day, causing more stress rather than less. For companies that experience significantly busier periods around holidays or during the summer, it may not be possible to extend the program across the whole year. And many companies, such as banks or insurance companies that require around-the-clock customer service or news organizations that follow a 24-hour news cycle, aren't able to shutter for even one day each week. But in those cases, companies could approach the four-day week the way they already handle weekends: Simply arrange teams' schedules so there are always people working.

No downsides

The ongoing push for a four-day workweek isn't the first time there's been a movement to upend the traditional model of work. Until 1926, the standard US workweek lasted six days. Then, Henry Ford reduced the workweek at his namesake company down to five days. He believed an extra day off would increase workers' productivity and give workers more leisure time to spend more money — hopefully on Ford cars. The trend caught on, and, after organizing by workers in favor of the shift, the Fair Labor Standards Act set the standard for the workweek at 44 hours; an amendment in 1940 set the now-standard 40-hour week. Fast forward to today, and our norms appear ripe for a shake-up once again.

Barry Prost, a cofounder of the Irish company Rent a Recruiter, a specialist talent-acquisition service, took part in the six-month 4 Day Week trial with the goal of addressing staff turnover — a problem for many businesses since the coronavirus pandemic. When the pandemic began, Rent a Recruiter was already moving to a permanent remote-work model, and after hearing about the program the company decided to try the four-day week as well. To Prost, it was particularly important to ensure the switch didn't hurt clients. Despite these reservations, Prost told me that not only had customers been supportive of the modified schedule, but some had even asked about implementing the policy themselves.

Crucially, the new approach has brought huge gains to the small startup, which employs 20 people. Over the six-month trial period, Rent a Recruiter doubled its gross profits and calculated that its staff's productivity doubled over that time as well. And though it wasn't the initial motivation, Prost told me the benefits had shown up in more than just the company's bottom line. "Anecdotally, we have a manager who's also a psychotherapist — she's now able to spend more time on her therapy practice," he said. "We've got mums and parents who are able to drop off and pick up their kids on a Friday, which they wouldn't have been able to do otherwise."

While staff well-being and retention are important, the trial also was associated with a revenue boost among the participating companies. Among the 16 companies in the trial that provided revenue data, combined revenue for the companies, weighted by size, increased by 8.14%, which for some companies was nearly 40% higher than revenue growth during the same six-month period of the previous year.

The companies that took part in the trial have reported almost no downsides. None of the 27 companies that filled out a final survey for participants said they had any plans to return to a five-day week. And nearly all of the 495 employees involved in the trial wanted to maintain the four-day working week. According to the post-trial surveys, everyone from CEOs and managers to junior employees noticed far-reaching benefits, and a new UK-wide trial is now underway.

Fewer work hours may also help the environment and gender inequality

While adopters of a four-day workweek might be primarily seeking a business impact — in revenue or employee well-being — there could also be less-obvious benefits.

For one thing, less time working correlates with lower carbon emissions — people are commuting less, and businesses use less energy. The 4 Day Week trial found that participants spent an hour less time commuting than before the trial. And as Orla Kelly, an environmental sociologist at University College Dublin who was the lead researcher for the 4 Day Week trial, told me, the shorter workweek also helps people make more pro-environmental choices. "When people are working longer hours, they tend to be in this kind of work-spend cycle where consumption patterns tend to be quite intensive," Kelly said. With less free time, people are more likely to buy food in disposable plastic packaging, drive to work instead of walking or taking public transportation, and spend more money on material goods. Kelly tells me that because this is hard to measure, the research is still in its early stages, but she hopes to dive deeper into the idea and provide more concrete evidence of the environmental benefits of a shorter working week.

A four-day week also provides vast improvements in well-being, life satisfaction, and sleep for women . Since women tend to take on more caring responsibilities, the extra day off work was most beneficial for them, allowing the extra load of emotional labor to be spread more evenly. In Ireland, where many of the companies in the trial were based, 70% of part-time workers are women . "Women tend to often be in jobs that pay less, so they tend to be the ones that move to part time, even if they don't want to," Kelly told me. In the past few years especially, women have been leaving the workforce in droves , or cutting back hours, over burnout or a lack of childcare options. "This can be problematic for their long-term career trajectory, their pension contributions, and the dynamics of power within the household," Kelly said. Cutting back working hours for everyone helps women stay in their full-time jobs and not feel as if they're getting pushed out of the workforce. 

It's unlikely that the world will shift to a four-day week overnight, but the trial produced real benefits and found it's possible for many different kinds of corporations, as long as they are willing, to make the change. As companies continue to grapple with attracting and retaining staff, the four-day week could be a relatively simple solution. And after the latest trial, there aren't many excuses not to try it out.

Molly Lipson  is a freelance writer and an organizer from the UK.

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Don’t say ‘prove’: How to report on the conclusiveness of research findings

This tip sheet explains why it's rarely accurate for news stories to report that a new study proves anything — even when a press release says it does.

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This work is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License .

by Denise-Marie Ordway, The Journalist's Resource February 13, 2023

This <a target="_blank" href="https://journalistsresource.org/media/dont-say-prove-research-tip-sheet/">article</a> first appeared on <a target="_blank" href="https://journalistsresource.org">The Journalist's Resource</a> and is republished here under a Creative Commons license.<img src="https://journalistsresource.org/wp-content/uploads/2020/11/cropped-jr-favicon-150x150.png" style="width:1em;height:1em;margin-left:10px;">

When news outlets report that new research studies prove something, they’re almost certainly wrong.

Studies conducted in fields outside of mathematics do not “prove” anything. They find evidence — sometimes, extraordinarily strong evidence.

It’s important journalists understand that science is an ongoing process of collecting and interrogating evidence, with each new discovery building on or raising questions about earlier discoveries. A single research study usually represents one small step toward fully understanding an issue or problem.

Even when scientists have lots of very strong evidence, they rarely claim to have found proof because proof is absolute. To prove something means there is no chance another explanation exists.

“Even a modest familiarity with the history of science offers many examples of matters that scientists thought they had resolved, only to discover that they needed to be reconsidered,” Naomi Oreskes , a professor of the history of science at Harvard University, writes in a July 2021 essay in Scientific American. “Some familiar examples are Earth as the center of the universe, the absolute nature of time and space, the stability of continents, and the cause of infectious disease.”

Oreskes points out in her 2004 paper “ Science and Public Policy: What’s Proof Got To Do With It? ” that “proof — at least in an absolute sense — is a theoretical ideal, available in geometry class but not in real life.”

Math scholars routinely rely on logic to try to prove something beyond any doubt. What sets mathematicians apart from other scientists is their use of mathematical proofs, a step-by-step argument written using words, symbols and diagrams to convince another mathematician that a given statement is true, explains Steven G. Krantz , a professor of mathematics and statistics at Washington University in St. Louis.

“It is proof that is our device for establishing the absolute and irrevocable truth of statements in our subject,” he writes in “ The History and Concept of Mathematical Proof .” “This is the reason that we can depend on mathematics that was done by Euclid 2300 years ago as readily as we believe in the mathematics that is done today. No other discipline can make such an assertion.”

If you’re still unsure how to describe the conclusiveness of research findings, keep reading. These four tips will help you get it right.

1. Avoid reporting that a research study or group of studies “proves” something — even if a press release says so.

Press releases announcing new research often exaggerate or minimize findings, academic studies have found . Some mistakenly state researchers have proven something they haven’t.

The KSJ Science Editing Handbook urges journalists to read press releases carefully. The handbook, a project of the Knight Science Journalism Fellowship at MIT , features guidance and insights from some of the world’s most talented science writers and editors.

“Press releases that are unaccompanied by journal publications rarely offer any data and, by definition, offer a biased view of the findings’ value,” according to the handbook, which also warns journalists to “never presume that everything in them is accurate or complete.”

Any claim that researchers in any field outside mathematics have proven something should raise a red flag for journalists, says Barbara Gastel , a professor of integrative biosciences, humanities in medicine, and biotechnology at Texas A&M University.

She says journalists need to evaluate the research themselves.

“Read the full paper,” says Gastel, who’s also director of Texas A&M University’s master’s degree program in science and technology journalism . “Don’t go only on the news release. Don’t go only on the abstract to get a full sense of how strong the evidence is. Read the full paper and be ready to ask some questions — sometimes, hard questions — of the researchers.”

2. Use language that correctly conveys the strength of the evidence that a research study or group of studies provides.

Researchers investigate an issue or problem to better understand it and build on what earlier research has found. While studies usually unearth new information, it’s seldom enough to reach definitive conclusions.

When reporting on a study or group of studies, journalists should choose words that accurately convey the level of confidence researchers have in the findings, says Glenn Branch , deputy director of the nonprofit National Center for Science Education , which studies how public schools, museums and other organizations communicate about science.

For example, don’t say a study “establishes” certain facts or “settles” a longstanding question when it simply “suggests” something is true or “offers clues” about some aspect of the subject being examined.

Branch urges journalists to pay close attention to the language researchers use in academic articles. Scientists typically express themselves in degrees of confidence, he notes. He suggests journalists check out the guidance on communicating levels of certainty across disciplines offered by the Intergovernmental Panel on Climate Change , created by the United Nations and World Meteorological Organization to help governments understand, adapt to and mitigate the impacts of climate change.

“The IPCC guidance is probably the most well-developed system for consistently reporting the degree of confidence in scientific results, so it, or something like it, may start to become the gold standard,” Branch wrote via email.

Gastel says it is important journalists know that even though research in fields outside mathematics do not prove anything, a group of studies, together, can provide evidence so strong it gets close to proof.

It can provide “overwhelming evidence, particularly if there are multiple well-designed studies that point in the same direction,” she says.

To convey very high levels of confidence, journalists can use phrases such as “researchers are all but certain” and “researchers have as much confidence as possible in this area of inquiry.”

Another way to gauge levels of certainty: Find out whether scholars have reached a scientific consensus ,  or a collective position based on their interpretation of the evidence.

Independent scientific organizations such as the National Academy of Sciences, American Association for the Advancement of Science and American Medical Association issue consensus statements on various topics, typically to communicate either scientific consensus or the collective opinion of a convened panel of subject experts.

3. When reporting on a single study, explain what it contributes to the body of knowledge on that given topic and whether the evidence, as a whole, leans in a certain direction. 

Many people are unfamiliar with the scientific process, so they need journalists’ help understanding how a single research study fits into the larger landscape of scholarship on an issue or problem. Tell audiences what, if anything, researchers can say about the issue or problem with a high level of certainty after considering all the evidence, together.

A great resource for journalists trying to put a study into context: editorials published in academic journals. Some journals, including the New England Journal of Medicine and JAMA , the journal of the American Medical Association, sometimes publish an editorial about a new paper along with the paper, Gastel notes.

Editorials, typically written by one or more scholars who were not involved in the study but have deep expertise in the field, can help journalists gauge the importance of a paper and its contributions.

“I find that is really handy,” Gastel adds.

4. Review headlines closely before they are published. And read our tip sheet on avoiding mistakes in headlines about health and medical research.

Editors, especially those who are not familiar with the process of scientific inquiry, can easily make mistakes when writing or changing headlines about research. And a bad headline can derail a reporter’s best efforts to cover research accurately.

To prevent errors, Gastel recommends reporters submit suggested headlines with their stories. She also recommends they review their story’s headline right before it is published.

Another good idea: Editors, including copy editors, could make a habit of consulting with reporters on news headlines about research, science and other technical topics. Together, they can choose the most accurate language and decide whether to ever use the word ‘prove.’

Gastel and Branch agree that editors would benefit from science journalism training, particularly as it relates to reporting on health and medicine. Headlines making erroneous claims about the effectiveness of certain drugs and treatments can harm the public. So can headlines claiming researchers have “proven” what causes or prevents health conditions such as cancer, dementia and schizophrenia.

Our tip sheet on headline writing addresses this and other issues.

“’Prove’ is a short, snappy word, so it works in a headline — but it’s usually wrong,” says Branch. “Headline writers need to be as aware of this as the journalists are.”

About The Author

Denise-Marie Ordway

New Research Offers The Best Argument Yet For A Four-Day Work Week

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Morning commuters cross London Bridge in the City of London, U.K. on Monday, March 14, 2022. A small pilot study of workers at companies based in the U.S., Ireland and Australia reported better employee well-being and other apparent benefits at companies that instituted a four-day work week. Photographer: Jason Alden/Bloomberg

W ork just four days a week but get paid for five? That may sound too good to be true, but new research says it may not be: More than two dozen companies that instituted a four-day week in a pilot project saw boosted sales, lower burnout and improved absenteeism, a new report finds.

The study , released Wednesday and conducted by researchers at Boston College, University College Dublin and Cambridge University, tracked employers in a small pilot research study. Companies in the research reported revenues that rose 8% over the study period, burnout scores that fell for two-thirds of employees and an amount of sick or personal leave time that declined by roughly a couple of hours a month.

“The results are pretty remarkable,” says Boston College professor Juliet Schor of the research, which involved 33 companies located in the U.S. and Ireland, as well as one headquartered in Australia. (Some employees were based globally; 27 of the 33 companies participated in the study). “I see this kind of trial as proof of concept. It shows that companies can succeed with this schedule and with this model.”

The study examines results from the first of several pilot studies being coordinated by an advocacy group, 4 Day Week Global , which promotes the idea of employees working 80% of their traditional hours for 100% of their original pay while still producing 10o% of their prior output.

“I see this kind of trial as proof of concept. It shows that companies can succeed with this schedule and with this model.” —Boston College professor and lead researcher Juliet Schor

While the group recruited the companies for the study and helped design the finished report, 4 Day Week Global was not involved in the data collection or analysis, and the research was funded by independent sources, says Schor.

The results follow a mid-point report of the group’s pilot program in the U.K., as well as a growing interest in the concept as burnout and mental health rise, technology expands working hours exponentially and expectations about work-life balance evolve following a global pandemic, generational shifts and a tight labor market that, until recently, has given workers more power.

“The combination of workplaces that were already too demanding and then the pandemic on top of that—it’s just brought too many people to where it’s too hard to cope with the levels of work time that are expected,” says Schor.

The not-for-profit group was launched by Charlotte Lockhart and Andrew Barnes , an entrepreneur who instituted a four-day week at his New Zealand company, Perpetual Guardian, and provides a platform for those interested in a four-day week practices.

Lockhart said in an interview that she often gets the question “if you’re going to squeeze all of that into four days, aren’t your people going to burn out?” But she believes the results help bolster why that doesn’t happen: By becoming more productive, cancelling unnecessary meetings, redesigning work practices and cutting out wasted time, she says, “I think the results back up what Andrew and I have been saying all of this time.”

Full results for the pilot of U.K. companies, which reported mid-point results in September and includes some 70 companies, are due in February, Lockhart says.

The pilot study for the U.S. and Ireland, which included 903 employees from the participating companies, 495 of which responded to the researchers’ surveys, is small. Still, it offers a snapshot of how workers feel about the approach: They reported greater control over their schedules, higher levels of productivity and a greater sense of how well they were doing their jobs.

Schor is careful to note that while improved employee well-being scores are plausibly tied to a four-day week model, it’s unclear whether the company’s results, such as increased revenues, can be attributed to shorter work hours. Many are small companies that were already growing quickly, and the study only had one “control” employer working traditional hours.

But none of the 27 companies that participated said they were planning to end the approach, says Schor, who has researched long work hours in America since the early 1990s . “I am not saying that every company can succeed tomorrow with this model. ... But what I think is going to happen is it’s going to be viable for more and more companies.”

“We’re no longer the crazy people in the room. The conversation seems to have shifted from why should we reduce work time to how can we reduce work time.” —Charlotte Lockhart, founder and managing director, 4 Day Week Global

Lockhart and Barnes say that even with slowing hiring , mounting layoffs and the threat of a recession, they see increasing interest in the approach, including from larger companies that have not been as involved in early trials.

Unilever, for instance, said recently that it was expanding its four-day week trial in New Zealand to Australia after encouraging results.

“Even with a slowing economy, what we’re seeing is a tight labor market,” Barnes says. A four-day model that requires the same amount of output can help increase focus on productivity and reduce commuting and energy costs, as well as wage inflation, Barnes argues.

“We’re no longer the crazy people in the room,” Lockhart says. “The conversation seems to have shifted from why should we reduce work time to how can we reduce work time.”

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A blood test for long Covid is possible, a study suggests

More than three years into the pandemic, the millions of people who have suffered from long Covid finally have scientific proof that their condition is real.

Scientists have found clear differences in the blood of people with long Covid — a key first step in the development of a test to diagnose the illness.

The findings, published Monday in the journal Nature , also offer clues into what could be causing the elusive condition that has perplexed doctors worldwide and left millions with ongoing fatigue, trouble with memory and other debilitating symptoms.

The research is among the first to prove that "long Covid is, in fact, a biological illness," said David Putrino, principal investigator of the new study and a professor of rehabilitation and human performance at the Icahn School of Medicine at Mount Sinai in New York.

Dr. Marc Sala, co-director of the Northwestern Medicine Comprehensive Covid-19 Center in Chicago, called the findings "important." He was not involved with the new research.

"This will need to be investigated with more research, but at least it's something because, quite frankly, right now we don't have any blood tests" either to diagnose long Covid or help doctors understand why it's occurring, he said.

Putrino and his colleagues compared blood samples of 268 people. Some had Covid but had fully recovered, some had never been infected, and the rest had ongoing symptoms of long Covid at least four months after their infection.

Several differences in the blood of people with long Covid stood out from the other groups.

The activity of immune system cells called T cells and B cells — which help fight off germs — was "irregular" in long Covid patients, Putrino said. One of the strongest findings, he said, was that long Covid patients tended to have significantly lower levels of a hormone called cortisol.

A major function of the hormone is to make people feel alert and awake. Low cortisol could help explain why many people with long Covid experience profound fatigue, he said.

"It was one of the findings that most definitively separated the folks with long Covid from the people without long Covid," Putrino said.

The finding likely signals that the brain is having trouble regulating hormones. The research team plans to dig deeper into the role cortisol may play in long Covid in future studies.

Meanwhile, doctors do not recommend simply boosting a person's cortisol levels in an attempt to "fix" the problem.

"There is no evidence that replacing cortisol in someone with long Covid would be a safe or effective thing to do," Sala said.

The study also found that dormant viruses , such as the one that causes mononucleosis, Epstein-Barr, come alive again in long Covid patients. It's unclear, however, whether those old viruses are causing symptoms or flagging a problem within the immune system.

"We were looking for signals, and we found them," said Akiko Iwasaki, one of the researchers and a professor of immunobiology and molecular, cellular and developmental biology at the Yale School of Medicine. "Now what we need to do is home in on each of these signals and understand better how the disease has been driven by these signals."

The investigators did not find significant evidence that long Covid is the result of an autoimmune disorder, in which the body attacks itself.

Dr. Clinton Wright, director of the National Institute of Neurological Disorders and Stroke's division of clinical research, said additional studies will be necessary to find other ways Covid may lead to long-term symptoms. One theory is that the virus is hiding in brain tissue or other organs.

"We're really interested in whether the virus still exists in reservoirs in the body," he said. "It's really hard to do that by measuring blood." He was not involved with the new study.

Long Covid affects 1 in 13 U.S. adults , or 7.5%, according to the Centers for Disease Control and Prevention.

The findings offer hope to patients like Joshua Roman, 39, of New York City, who participated in the study.

"We're in such a mysterious swamp of symptoms," he said. "My long Covid treatment is just management of symptoms ."

Roman, a professional musician who plays the cello, takes daily medication to ease the lingering physical trembling that affects his ability to perform.

"It would be great if we could get to the thing that's causing me to shake in the first place, but we still don't know exactly what that is," he said.

Follow  NBC HEALTH  on  Twitter  &  Facebook .

Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."

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October 24, 2022

Study offers new, sharper proof of early plate tectonics, flipping of geomagnetic poles

by Juan Siliezar, Harvard University

New research analyzing pieces of the most ancient rocks on the planet adds some of the sharpest evidence yet that Earth's crust was pushing and pulling in a manner similar to modern plate tectonics at least 3.25 billion years ago. The study also provides the earliest proof of when the planet's magnetic north and south poles swapped places.

The two results offer clues into how such geological changes may have resulted in an environment more conducive to the development of life on the planet.

The work, described in PNAS and led by Harvard geologists Alec Brenner and Roger Fu, focused on a portion of the Pilbara Craton in western Australia, one of the oldest and most stable pieces of the Earth's crust. Using novel techniques and equipment, the researchers show that some of the Earth's earliest surface was moving at a rate of 6.1 centimeters per year and 0.55 degrees every million years.

That speed more than doubles the rate the ancient crust was shown to be moving in a previous study by the same researchers. Both the speed and direction of this latitudinal drift leaves plate tectonics as the most logical and strongest explanations for it.

"There's a lot of work that seems to suggest that early in Earth's history plate tectonics wasn't actually the dominant way in which the planet's internal heat gets released as it is today through the shifting of plates," said Brenner, a Ph.D. candidate in the Graduate School of Arts and Sciences and member of Harvard's Paleomagnetics Lab. "This evidence lets us much more confidently rule out explanations that don't involve plate tectonics."

For example, the researchers can now argue against phenomena called " true polar wander " and "stagnant lid tectonics," which can both cause the Earth's surface to shift but aren't part of modern-style plate tectonics. The results lean more toward plate tectonic motion because the newly discovered higher rate of speed is inconsistent with aspects of the other two processes.

In the paper, the scientists also describe what's believed to be the oldest evidence of when Earth reversed its geomagnetic fields, meaning the magnetic North and South Pole flipped locations. This type of flip-flop is a common occurrence in Earth's geologic history with the pole's reversing 183 times in the last 83 million years and perhaps several hundred times in the past 160 million years, according to NASA .

The reversal tells a great deal about the planet's magnetic field 3.2 billion years ago. Key among these implications is that the magnetic field was likely stable and strong enough to keep solar winds from eroding the atmosphere. This insight, combined with the results on plate tectonics, offers clues to the conditions under which the earliest forms of life developed.

"It paints this picture of an early earth that was already really geodynamically mature," Brenner said. "It had a lot of the same sorts of dynamic processes that result in an Earth that has essentially more stable environmental and surface conditions, making it more feasible for life to evolve and develop."

Today, the Earth's outer shell consists of about 15 shifting blocks of crust, or plates, which hold the planet's continents and oceans. Over eons the plates drifted into each other and apart, forming new continents and mountains and exposing new rocks to the atmosphere, which led to chemical reactions that stabilized Earth's surface temperature over billions of years.

Evidence of when plate tectonics started is hard to come by because the oldest pieces of crust are thrust into the interior mantle, never to resurface. Only 5 percent of all rocks on Earth are older than 2.5 billion years old, and no rock is older than about 4 billion years.

Overall, the study adds to growing research that tectonic movement occurred relatively early in Earth's 4.5-billion-year history and that early forms of life came about in a more moderate environment. Members of the project revisited the Pilbara Craton in 2018, which stretches about 300 miles across. They drilled into the primordial and thick slab of crust there to collect samples that, back in Cambridge, were analyzed for their magnetic history.

Using magnetometers, demagnetizing equipment, and the Quantum Diamond Microscope—which images the magnetic fields of a sample and precisely identifies the nature of the magnetized particles—the researchers created a suite of new techniques for determining the age and way the samples became magnetized. This allows the researchers to determine how, when, and which direction the crust shifted as well as the magnetic influence coming from Earth's geomagnetic poles.

The Quantum Diamond Microscope was developed in a collaboration between Harvard researchers in the Departments of Earth and Planetary Sciences (EPS) and of Physics.

For future studies, Fu and Brenner plan keep their focus on the Pilbara Craton while also looking beyond it to other ancient crusts around the world. They hope to find older evidence of modern-like plate motion and when the Earth's magnetic poles flipped.

"Finally being able to reliably read these very ancient rocks opens up so many possibilities for observing a time period that often is known more through theory than solid data," said Fu, professor of EPS in the Faculty of Arts and Sciences. "Ultimately, we have a good shot at reconstructing not just when tectonic plates started moving, but also how their motions—and therefore the deep-seated Earth interior processes that drive them—have changed through time."

Journal information: Proceedings of the National Academy of Sciences

Provided by Harvard University

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Perspective

Facing cancer here's when to consider experimental therapies, and when not to.

Jeff Stewart

Experimental therapies for cancer can be tempting when you're sick, but many fail to offer any benefit. Cavan Images/Getty Images/Cavan Images RF hide caption

Experimental therapies for cancer can be tempting when you're sick, but many fail to offer any benefit.

Note: Molecular biologist and author Jeff Stewart has worked more than 15 years as a consultant to drugmakers, scrutinizing data on new treatments to fight cancer. Last July, the 50-year-old father of seven was diagnosed with stomach cancer himself. He spent much of the next 10 months in treatment, while also writing the newly published Living: Inspiration from a Father with Cancer.

His book is a compilation of life lessons and reflections that "helped me endure hard times and avoid harder ones," he says. Framed as a life guide for his kids, it also includes insider advice for anyone facing a cancer diagnosis. The following excerpts have been edited for length and clarity. --Editors

As a cancer patient, I'm getting forwarded many, many articles about early stage cancer treatments and alternative therapies. I think every cancer patient gets these. I'm public about my cancer, so I'm getting these from more than friends and family. I'm getting these also from people I've never met but who are trying to help.

Cancer treatments are not just a personal interest. Part of my job for over 15 years has been to advise pharma companies on cancer drugs. My clients have included big pharma and small biotechs. You'd know the big-pharma names. I've interviewed hundreds of oncologists over the years. Figuring out the scientific and commercial potential of a cancer drug is a normal day on the job for me.

Shots - Health News

Crispr gene-editing may boost cancer immunotherapy, new study finds, how to assess experimental treatments follow the evidence.

Basic rule of cancer treatments: Evidence wins. We need evidence to believe anything works. That's especially true for cancer.

Step one: Is the drug FDA-approved?

Step two: If the drug is approved, is the drug also recommended in cancer guidelines? If the approved drug is not in cancer guidelines, insurance companies aren't going to pay.

Step three: If the drug is neither approved nor in guidelines, is the drug in late-stage clinical trials? That usually means phase III . If so, then maybe a cancer patient can join those. If not in late-stage clinical trials, the drug is too early in testing to help most people who have cancer now.

Amazing result in a test tube? Talk to me in 15 years if I'm still here. Just started phase I clinical trials in people? Still too early to help me. Cures mice? Of all the oncologists I've interviewed about mouse data, I've been told by at least a quarter of them this exact punchline: "I've never treated a mouse for cancer." Yuk, yuk. Funny oncologists. It's not just snark. They have a point buried under their tired joke. Most things that cure cancer in mice don't work in people.

The author signs copies of his new book. Carissa Wadsack-Stewart/Jeff Stewart hide caption

It's worse than you imagine. Nearly every new thing coming out of a university is too early to help anyone who has cancer now. Worse, nearly everything fails. If that sounds jaded, I'm sorry. This is oncologists' lived reality.

Yes, there have been great strides in cancer treatment. The really promising drugs that can do anything in the short term are already in late-stage clinical trials. Oncologists read. They know what's coming. Anything early-stage will not, cannot cure someone who has cancer now. I have to think one of the worst parts of an oncologist's job is to explain why a miracle cure in early development holds no promise at all for a cancer patient today.

Hard truth: Most experimental cancer treatments fail

Here's what most people not immersed in oncology don't get. Even the most promising cancer drugs fail. Cancer drugs have the second-worst failure rate of any disease. Only Alzheimer's is worse.

Think of the tens of millions of dollars spent to get one cancer drug out of a university, into cell lines and mice, and finally into patients to be tested in clinical trials. That's a huge effort. It might take a decade. Those drugs that get tested in people have won a biotech lottery. For any cancer drug to be tested in people, the science has to be amazing . Scientists working on the drug believe it's a lock to work. There may be talk of a Nobel Prize or at least the Lasker Award. Everything seems sure to succeed. What could go wrong?

Do you want to take a guess at how many of those "sure winners" end up passing clinical trials? Seven percent . That's 7% of the best drugs that emerged from the best science and were so promising that a pharma company invested $10 million to more than $1 billion to test the drugs in patients. Ninety-three percent of the "winners" fail.

What about repurposed approved drugs? Approved drugs can be used off label by physicians. What if, say, an anti-parasite drug cured cancer? Why not take that?

The question is, again, where is the evidence? Cancer drugs are special. State laws require insurance companies to pay for cancer drugs any time independent cancer guidelines say the drugs should be used. Even if the drug is not FDA-indicated for the cancer, so long as the evidence shows the drug works, insurance companies must pay. Leading oncologists update cancer guidelines whenever the evidence gets good enough.

Why cancer guidelines are your friend

You see where this is going? For an approved drug not to be on cancer guidelines, the evidence sucks.

This is what I do when I'm forwarded information about nonstandard, alternative, or early cancer therapies: I hit delete. I know, even without reading, the evidence isn't there yet. Things that look fantastic almost always fail. Anything early-stage is not helpful for anyone who has cancer now.

Snake-oil sellers are all over cancer patients . They are all over me. These hucksters will make a buck ripping off cancer patients if they can. These hucksters are vultures (or optimistic to the point of delusion). They don't have evidence. See above.

Even legitimate innovators have a hard time imagining it's possible their cancer drug will fail. But their cancer drug will fail most of the time. It's not something scientists like to admit to themselves.

If you want to take an unproven libido booster, that's one thing. But cancer? Don't waste the time you have left.

What is a cancer patient supposed to do when the standard treatments seem to be pointless? What if the odds with standard treatments are so bad that there might as well be no treatment at all? I'd say to ask your oncologist if there are promising, late-stage clinical trials you can join. This is a perfect question.

A late-stage clinical trial is the best chance a cancer patient has to get a next-generation treatment before approval. We're in a golden age of cancer immunotherapy. There are promising immunotherapies in late-stage clinical trials. If you're enrolled in a trial, not only do you get a chance for a new treatment, you will help move the science along so future patients may benefit.

Understanding the disease and its treatment can ease fears

If you or a loved one has received a cancer diagnosis, I'm sorry. I'm sorry this has happened to you. Cancer is frightening. It's all so complicated that, when we get the diagnosis, we don't know what to think. We barely know what to feel. Understanding cancer and its treatment — even the hard things to hear — helped me be less afraid.

I hope, I pray, my story helps you even though your cancer, your experience, may be different from mine. I'm not going to pretend to be an oncologist and give treatment advice — listen to your oncologist — but if you need to talk, I'm at [email protected] . I'll respond if I'm able.

What's next? "Pre-bunking" instead of debunking bad information about cancer treatment

To my colleagues in the health care industry: There is an opportunity to do good here. The cancer patient needs a trusted, friendly voice to help explain things — on call, 24/7. The health care system isn't prepared to do this. The vacuum is filled now by fraud and fear.

Cancer patients today are not in a neutral information environment. Instead, cancer patients are flooded with false facts and quacks who promise 100% cure rates. That's the reality we live in.

There is one defense against misinformation that we know works: pre-bunking. We must fill cancer patients with facts in forms they can understand before the frauds get to them. How do we do this without hiring a call-center army of oncologists? I'm hopeful that artificial intelligence trained on the best evidence will be a "cancer counselor" that will be there to explain things to patients anytime, day or night.

There is upside for us all: Patients who follow evidence-based medicine have double the chance of surviving their cancer, research has found. Demonstrating an AI cancer counselor has a positive effect on medication compliance or even overall survival in a clinical setting should be possible with a modest number of clinical-trial patients.

The pieces are there. Done right, an AI cancer counselor could save more lives than many cancer treatments. If I survive my cancer, I hope to join you in the effort.

Jeff Stewart is a managing director at Syneos Health Consulting. All views, thoughts and opinions expressed here are his own, and not necessarily those of his employer or others. This essay was adapted from the book, Living: Inspiration from a Father with Cancer, published by Wadsak-Stewart Press on May 15, 2023. He can be reached at [email protected] .

• alternative cancer treatment
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• Open access
• Published: 28 May 2019

Transforming evidence for policy and practice: creating space for new conversations

• Kathryn Oliver   ORCID: orcid.org/0000-0002-4326-5258 1 &
• Annette Boaz 2  

Palgrave Communications volume  5 , Article number:  60 ( 2019 ) Cite this article

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A Correction to this article was published on 29 August 2019

This article has been updated

For decades, the question of how evidence influences policy and practice has captured our attention, cutting across disciplines and policy/practice domains. All academics, funders, and publics have a stake in this conversation. There are pockets of great expertise about evidence production and use, which all too often remains siloed. Practical and empirical lessons are not shared across disciplinary boundaries and theoretical and conceptual leaps remain contained. This means that we are not making the most of vast and increasing investment in knowledge production. Because existing lessons about how to do and use research well are not shared, funders and researchers are poorly equipped to realise the potential utility of research, and waste resources on—for example—ineffective strategies to create research impact. It also means that the scarce resources available to study evidence production and use are misspent on overly-narrow or already-answered questions. Patchy and intermittent funding has failed to build broadly relevant empirical or theoretical knowledge about how to make better use of evidence, or to build the communities required to act on this knowledge. To transform how we as a community think about what evidence is, how to generate it, and how to use it well, we must better capture lessons being learned in our different research and practice communities. We must find ways to share this knowledge, to embed it in the design of our research systems and practices, and work jointly to establish genuine knowledge gaps about evidence production and use. This comment sets out one vision of how that might be accomplished, and what might result.

Are we investing wisely in research for society?

For decades, conversations between research funders, users, and producers have focused on different aspects of what evidence is, the roles it plays in policy and practice, and the different ways in which roles can be enhanced and supported. Most researchers feel unequivocally that ‘more research’ is always better—and funders and governments seem to agree (Sarewitz, 2018 ). Governments are increasingly using investments explicitly to help create the evidence base for better decision-making. For example, funding has been explicitly focused on the United Nation’s Sustainable Development Goals (UKRI-UNDP, 2018 ). The UK government has made several targeted investments, including the £1.5 billion Global Challenges Research Fund to address substantive social problems, (Gov. UK, 2016 ; UKRI, 2017 ), and in health, the thirteen (up from nine) Collaborations for Leadership in Applied Health Research and Care, which received £232 million 2008–2019 (NIHR, 2009 ). This investment looks set to continue with a further £150 million allocated to the Applied Research Collaborations (NIHR, 2018 ). In the US, the Trump administration recently signed into law $176.8 billion for research and development, of which $543 million is specifically for translational health research (Science, 2018 ). These funds are made available to researchers with an effective proviso that the research is targeted towards questions of direct interest to policymakers and practitioners.

There has also been an increase in the infrastructure governments provide, such as scientific advisory posts and professionals (Doubleday and Wilsdon, 2012 ; Gluckman, 2014 ), and a range of secondments and fellowship opportunities designed to ‘solve’ the problem of limited academic-policy engagement (Cairney and Oliver, 2018 ). The UK Government recently asked departments to produce research priority areas (Areas of Research Interest (ARIs)), to guide future academic-policy collaboration (Nurse, 2015 ). Yet, there has been almost no evaluation of these activities. There is limited evidence about how to build the infrastructure to use evidence in impactful ways and limited evidence about the impact of this investment (Kislov et al., 2018 ). We simply do not know whether the growth of funding, infrastructure, or initiatives has actually improved research quality, or led to improvements for populations, practice or policy.

Thus, despite our ever-growing knowledge about our world, physical and social, it is not easy to find answers to the challenges facing us and our governments. Spending ever-increasing amounts on producing research evidence is not likely to help, if we do not understand how to make the most of these investments. Discussions about wastage within the research system often focus on valid concerns about reproducibility and quality (Bishop, 2019 ), but until we also understand the broader political and societal pressure shaping what evidence is produced and how, we will not be able to reduce this waste (Sarewitz, 2018 ). In short, our research systems are not guided by current theory about what types of knowledge are most valuable to help address societal problems, or how to produce useful evidence, or how to use this knowledge in policy and practice setting.

Who knows about how to improve evidence production and use?

Fortunately, even if under-used, there is a significant body of academic and practical knowledge about how evidence is produced and used. Several disciplines take the question of evidence production and use as a core concern, and this inherently transdisciplinary space has become populated by research evidence from different academic and professional traditions, jurisdictions and contexts.

Much of the funded research into knowledge production and use has been conducted in health and health care, and other applied disciplines. Although there are perennial inquiries about the ‘best’ research methods which should inform policy and practice (Haynes et al., 2016 ), this field has offered some very practical insights, from identifying factors which influence evidence use (Innvaer et al., 2002 ; Oliver et al., 2014 ; Orton et al., 2011 ), to identifying types of evidence used in different contexts (Dobrow et al., 2004 ; Oliver and de Vocht, 2015 ; Whitehead et al., 2004 ). Researchers have explored strategies to increase evidence use (Dobbins et al., 2009 ; Haynes et al., 2012 ; Lavis et al., 2003 ), and developed structures to support knowledge production and use—in the UK, see, for example, the What Works Centres, Policy Research Units, Health Research Networks and so forth (Ferlie, 2019 ; Gough et al., 2018 ). Similar examples can be found in the US (Tseng et al., 2018 ; Nutley and Tseng, 2014 ) and the Netherlands (Wehrens et al., 2010 ). Alongside these practical tools, critical research has helped us to understand the importance of diverse evidence bases (e.g., Brett et al., 2014 ; Goodyear-Smith et al., 2015 ), of including patients and stakeholders in decision-making (Boaz et al., 2016 ; Liabo and Stewart, 2012 ), and to contextualise the drive for increased impact outcomes (Boaz et al., 2019 ; Locock and Boaz, 2004 ; Nutley et al., 2000 ).

The social sciences have provided research methods to investigate the various interfaces between different disciplines and their potential audiences. Acknowledging insights from philosophy, critical theory and many other field (see, e.g., Douglas, 2009 ), we highlight two particular perspectives. Firstly, policy studies has helped us to understand the processes of decision-making and the (political) role of evidence within it (Dye, 1975 ; Lindblom, 1990 ; Weiss, 1979 ). A subfield of ‘the politics of evidence-based policymaking’ has grown up, using an explicitly political-science lens to examine questions of evidence production and use (Cairney, 2016b ; Hawkins and Ettelt, 2018 ; Parkhurst, 2017 ). Political scientists have commented on the ways in which political debate has been leveraged by scientific knowledge, with particular focuses on social justice, and the uses of evidence to support racist and sexist oppression (Chrisler, 2015 ; Emejulu, 2018 ; Lopez and Gadsden, 2018 ; Malbon et al., 2018 ; Scott, 2011 ).

Secondly, the field of Science and Technology studies (STS) treats the practice and purpose science itself as an object of study. Drawing on philosophies of science and sociologies of knowledge and practice, early theorists described science as an esoteric activity creating knowledge through waves of experimentation (Kuhn, 1970 ; Popper, 1963 ). This was heavily critiqued by social constructivists, who argue that all knowledge was inherently bound to cultural context and practices (Berger and Luckmann, 1966 ; Collins and Evans, 2002 ; Funtowicz and Ravetz, 1993 ). Although some took this to mean that science was just another way of interpreting reality of equal status with other belief systems, most see these insights as demonstrating the importance of understanding the social context within which scientific practices and objects were conducted and described (Latour and Woolgar, 2013 ; Shapin, 1995 ). Similarly, Wynne showed how social and cultural factors determine what we consider ‘good’ evidence or expertise (Wynne, 1992 ). More recently, scholars have focused on how science and expertise is politicised through funding and assessment environments (Hartley et al., 2017 ; Jasanoff, 2005 ; Jasanoff and Polsby, 1991 ; Prainsack, 2018 ), the cultures and practices of research (Fransman, 2018 ; Hartley, 2016 ), through the modes of communication with audiences, and on the role for scientific advice around emerging technologies and challenges (Lee et al., 2005 ; Owen et al., 2012 ; Pearce et al., 2018 ; Smallman, 2018 ; Stilgoe et al., 2013 ).

Are we acting on these lessons?

However, funders and researchers rarely draw on the learning from these different fields; nor is learning shared between disciplines and professions (Oliver and Boaz, 2018 ). Thus, we have sociologists of knowledge producing helpful theory about the complex and messy nature of decision-making and the political nature of knowledge (e.g., Lancaster, 2014 ); but this is not drawn on by designers of research partnerships or evaluators of research impact (Chapman et al., 2015 ; Reed and Evely, 2016 ; Ward, 2017 ). This leaves individual researchers with the imperative to do high quality research and to demonstrate impact, but with little useful advice about how as individuals or institutions they might achieve or measure impact (Oliver and Cairney, 2019 ), leading to enormous frustration, duplicated and wasted effort. Even more damagingly, researchers produce poor policy recommendations, or naively engage in political debates with no thought about the possible costs and consequences for themselves, the wider sector, or publics.

We recognise that engaging meaningfully with literatures from multiple disciplines is too challenging a labour for many. The personal and institutional investment required to engage with the practical and scholarly knowledge about evidence production and use is—on top of other duties—beyond most of us. Generating consensus about the main lessons is itself challenging, although initial attempts have been made (Oliver and Pearce, 2017 ). Across the diverse literature on evidence use, terms are defined and mobilised differently. Working out what the terms are implying and what is at stake in the alternative mobilisation of these terms is a huge task. Many researchers are only briefly able to enter this broader debate, through tacked-on projects attached to larger grants. There is no obvious career pathway for those who want to remain at this higher level. There are simply too many threads pulling researchers and practitioners back into their ‘home’ disciplines and domains, which prevents people undertaking the labour of learning the key lessons from multiple fields.

Yet the history of research in this area, scattered and patchy though it is, shows us how necessary this labour is if useful, meaningful research is to be done and used (DuMont, 2019 ). Too much time and energy has been spent investigating questions which have been long-since answered—such as whether RCTs should be used to investigate policy issues, whether we need a pluralistic approach to research design; whether to invest in relationships as well as data production. But governments and universities have also failed to create environments where knowledge producers are welcome and useful in decision-making environments; where their own staff feel able to freely discuss and experiment with ideas; and universities consistently fail to reward or support those who want to create social change or work at the interfaces between knowledge production and use.

This failure to draw together key lessons also means that the scarce resources allocated to the study of evidence production and use have been misspent. There has been no sustained interdisciplinary funding for empirical research studies into evidence production and use in the UK, and in the US only over the last 15 years (DuMont, 2019 ). This has led to a dearth of shared empirical and theoretical evidence, but also a lack of community, which has had a detrimental effect on the scholarship in this space. All too often, research funding goes towards already-answered questions (such as whether bibliometrics are a good way to capture impact). We must ensure that new research on evidence production and use addresses genuine gaps. That can only be done by making existing knowledge more widely available and working together to generate collaborative research agendas.

An unfortunate side-effect of this lack of community is that many who enter it do so with the sense that it is a new, ‘emerging’ field, which will generate silver-bullet solutions for researchers and funders. Because it is new to them, researchers feel it must be new to all—not realising that their own journey has been undertaken by many others before them. For instance, there are many initiatives which claim to be ‘newly addressing’ the problem of ‘evidence use’, ‘research on research’, the ‘science of science’, ‘meta-science’, or some other variant. Whether they explore the allocation and impact of research funding and evaluation, the infrastructure of policy research units or the practice of collaborative research, they all make vital contributions. But to claim as many do that it is an ‘emerging field’ illustrates how easy it is, even with the best of intentions, to ignore existing expertise on the production and use of evidence. We must better articulate the difference between these pieces of the puzzle, and the difference those differences make. Too many are claiming that their piece provides the whole picture. In turn, funders feel they have done their part by funding this small piece of research, but remain ignorant of the existing knowledge, and indeed of the real gaps.

Research on evidence production and use is often therefore not as useful as it should be. Failing to draw on existing literature, the solutions proposed by most commentators on the evidence-policy/practice ‘gap’ often do not take into account the realities of complex and messy decision-making, or the contested and political nature of knowledge construction—leading to a situation where an author synthesising lessons from across the field can end up sharing a set of normative statements that might imply that there has been no conceptual leap in 20 years (see e.g., French, 2018 ; Gamoran, 2018 ).

Evidence and policy/practice studies: our tasks

There are therefore two key tasks for those primarily engaged in researching and teaching evidence production and use for policy and practice, which are to (1) identify and share key lessons more effectively and (2) to build a community enabling transdisciplinary evidence to be produced and used, which addresses real gaps in the evidence base and helps decision-makers transform society for the better. We close with some suggestions about possible steps we can take towards these goals.

Firstly, we must better communicate our key lessons. We would like to help people articulate the hard-won, often disciplinary-specific lessons from their own work for others—and to work with partners to embed them into the design, practice and evaluation of research. For instance, critical perspectives on power can describe the lines of authority and the institutional governance surrounding decision-making (Bachrach and Baratz, 1962 ; Crenson, 1971 ; Debnam, 1975 ); the interpersonal dynamics which determine everything from the credibility of evidence to the placement of topics on policy agendas (Oliver and Faul, 2018 ; Tchilingirian, 2018 ; White, 2008 ); to the practice of research itself, and the ways in which assumed and enacted power leads to the favouring of certain methodologies and narratives (Hall and Tandon, 2017 ; Pearce and Raman, 2014 ). How might this translate into infrastructure and funding to support equitable research partnerships (Fransman et al., 2018 )? What other shared theory and practical insights might help us transform how we do and use research?

Secondly, we must generate research agendas collaboratively. In our view, the only way to avoid squandering resources on ineffective research on research is to work together to share emerging ideas, and to produce genuinely transdisciplinary questions. We made a start on this task at recent meetings. A 2018 Nuffield Foundation-funded symposium brought together leading scholars, practitioners and policymakers, and funders, to share learning about evidence use and to identify key gaps. We followed this meeting with a broader discussion at the William T. Grant Use of Research Evidence meeting in March 2019 which has also contributed to our thinking.

We initiated the conversation with a Delphi exercise to identify key research questions prior to the meeting. We refined the list, and during the meeting we asked participants to prioritise these. This was a surprisingly challenging process, which revealed that even to reach common understanding about the meaning of a research question, let alone the importance, discussants had to wade through decades-worth of assumptions, biases, preferences, language nuances and habits.

Based on this analysis, we identify three main areas of work which are required to transform how we think about to create and use evidence (Table 1 ):

Transforming knowledge production

Transforming translation and mobilisation

Transforming decision-making

The topics below were selected to indicate the broad range of empirical and normative questions which need broader discussion, and are by no means definitive. Of course, much research on some topics has already been done, but we have included them—because even if research already exists, it is not widely enough known to routinely inform research users, funders or practitioners about how to better produce or use evidence. We observe that much of the very limited funding to investigate evidence production and use has gone to either developing metrics (responsible or otherwise, Row 2 column 4) or tools to increase uptake (Row 2, column 4), to the relative neglect of everything else. There are significant gaps which can only be addressed jointly across disciplines and sectors, and we welcome debates, additions, and critiques about how to do this better.

A shared research agenda

As we note above, these topics are drawn from proposed questions and discussions by an interdisciplinary group of scholars, practitioners, funders and other stakeholders. It became clear during this process that many were unaware of relevant research which had already been undertaken under these headings. These topics reflect our own networks and knowledge of the field, so cannot be regarded as definitive. We need and welcome partnership with others working in this space to attempt to broaden the conversation as much as possible. We have selected a proportion of the selected topics to illustrate a number of points.

First, that no one discipline or researcher could possibly have the skills or knowledge to answer all of these questions. Interdisciplinary teams can be difficult to assemble, but clearly required. We need leadership in this space to help spot opportunities to foster interdisciplinary research and learning.

Second that all of these topics could be framed and addressed in multiple ways, and many have been. Many are discussed, but there is little consensus; or there is consensus within disciplines but not between them. Some topics have been funded and others have not. We feel there is an urgent need to identify where research investment is required, where conversations need to be supported, and where and how to draw out the value of existing knowledge. Again, we need leadership to help us generate collaborative research agendas.

Third, that while we all have our own interests, the overall picture is far more diverse, and that there is a need for all working in this area to clearly define what their contributions are in relation to the existing evidence and communities. A shared space to convene and learn from one another would help us all understand the huge and exciting space within which we are working.

Finally, this is an illustrative set of topics, and not an exhaustive one. We would not claim to be setting the definitive research agenda in this paper. Rather, we are setting out the need to learn from one another and to work together in the future. Below, we describe some examples of the type of initial discussions which might help us to move forward, using our three themes of knowledge production, knowledge mobilisation, and decision-making. We have cited relevant studies which set out research questions or provide insights. By doing so, we hope to demonstrate the breadth of disciplines and approaches which are being used to explore these questions; and the potential value of bringing these insights together.

Firstly, we must understand who is involved in shaping and producing the evidence base. Much has been written about the need to produce more robust, meaningful research which minimises research waste through improving quality and reporting (Chalmers et al., 2014 ; Glasziou and Chalmers, 2018 ; Ioannidis, 2005 ), and the infrastructure, funding and training which surround knowledge production and evaluation have attracted critical perspectives (Bayley and Phipps, 2017 ; Gonzalez Hernando and Williams, 2018 ; Katherine Smith and Stewart, 2017 ). Current discourses around ‘improving’ research focus on making evidence more rigorous, certain, and relevant; but how are these terms interpreted locally in different policy and practice contexts? How are different forms of knowledge and evidence assessed, and how do these criteria shape the activities of researchers?

Enabling researchers to reflect on their own role in the ‘knowledge economy’—that is, the production and services attached to knowledge-intensive activities (usually but not exclusively referring to technological innovation (Powell and Snellman, 2004 ))—requires engagement with this history.

This might mean asking questions about who is able to participate in the practice and evaluation of research. Who is able to ask and answer questions? What questions are asked and why? Who gets to influence research agendas? We know that there are barriers to participation in research for minority groups, and for many research users (Chrisler, 2015 ; Duncan and Oliver, 2017 ; Scott et al., 2009 ). At a global level, how are research priorities set by, for example, international funders and philanthropists? How can we ensure that local and indigenous interests and priorities are not ignored by predominantly Western research practices? How are knowledge ‘gaps’ or areas of ‘non-knowledge’ constructed, and what are the power relationships underpinning that process (Nielsen and Sørensen, 2017 )? There are important questions about what it means to do ethical research in the global society, with honesty about normative stances and values (Callard and Fitzgerald 2015 ), which apply to the practices we engage in as much as the substantive topics we focus on (Prainsack et al., 2010 ; Shefner et al., 2014 ).

It might also mean asking about how we do research. Many argue that research (particularly funded through responsive-mode arrangements) progresses in an incremental way, with questions often driven by ease, rather than public need (Parkhurst, 2017 ). Is this the most efficient way to generate new knowledge? How does this compare with, for example, random research funding (Shepherd et al., 2018 )? Stakeholder engagement is said to be required for impact, yet we know it is costly and time-consuming (Oliver et al., 2019 , 2019a ). How can universities and funders support researchers and users to work together long-term, with career progression and performance management untethered from simplistic (or perhaps any) metrics of impact? Is coproduced research truly more holistic, useful, and relevant? Or does inviting in different interests to deliberate on research findings, even processes, distort agendas and politicise research (Parkhurst and Abeysinghe, 2016 )? What are the costs and benefits to these different systems and practices? We know little about whether (and if so how well) each of these modes of evidence production leads to novel, useful, meaningful knowledge; nor how these modes influence the practice or outputs of research.

Transforming evidence translation and mobilisation

Significant resources are put into increasing ‘use’ of evidence, through interventions (Boaz et al., 2011 ) or research partnerships (Farrell et al., 2019 ; Tseng et al., 2018 ). Yet ‘use’ is not a straightforward concept. Using research well implies the existence of a diverse and robust evidence base; a range of pathways for evidence to reach decision-makers; both users and producers of knowledge having the capacity and willingness to engage in relationship-building and deliberation about policy and practice issues; research systems supporting individuals and teams to develop and share expertise.

More attention should be paid to how evidence is discussed, made sense of, negotiated and communicated—and the consequences of different approaches. This includes examining the roles of people involved in the funding of research, through to the ways in which decision-makers access and discuss evidence of different kinds. How can funders and universities create infrastructure and incentives to support researchers to do impactful research, and to inhabit boundary spaces between knowledge production and use? We know that potential users of research may sit within or outside government, with different levels and types of agency, making different types of decisions in different contexts (Cairney, 2018 ; Sanderson, 2000 ). Yet beyond ‘tailoring your messages’, existing advice to academics does not help them navigate this complex system (Cairney and Oliver, 2018 ). To take this lesson seriously, we might want to think about the emergence of boundary spanning- organisations and individuals which help to interface between research producers (primarily universities, but also civil society) and users (Bednarek et al., 2016 ; Cvitanovic et al., 2016 ; Stevenson, 2019 ). What types of interfacing are effective, and how—and how do interactions between evidence producers and users shape both evidence and policy? How might policies on data sharing and open science influence innovation and knowledge mobilisation practices?

Should individual academics engage in advocacy for policy issues (Cairney, 2016a ; Smith et al., 2015 ), using emotive stories or messaging to best communicate (Jones and Crow, 2017 ; Yanovitzky and Weber, 2018 ), or rather be ‘honest brokers’ representing without favour a body of work (Pielke, 2007 )? Or should this type of dissemination work be undertaken by boundary organisations or individuals who develop specific skills and networks? There is little empirical evidence about how best to make these choices (Oliver and Cairney, 2019 ), or how these consequences affect the impact or credibility of evidence (Smith and Stewart, 2017 ); nor is there good quality evidence about the most effective strategies and interventions to increase engagement or research uptake by decision-makers or between researchers and their audiences (Boaz et al., 2011 ). It seems likely that some researchers may get involved and others stay in the hinterlands (Locock and Boaz, 2004 ), depending on skills and preference. However, it is not clear how existing studies can help individuals navigate these complex and normative choices.

Communities (of practice, within policy, amongst diverse networks) develop their own languages and rationalities. This will affect how evidence is perceived and discussed (Smallman, 2018 ). Russell and Greenhalgh have shown how competing rationalities affect the reasoning and argumentation deployed in decision-making contexts (Greenhalgh and Russell, 2006 ; Russell and Greenhalgh, 2014 ); how can we interpret local meanings and sense-making in order to better communicate about evidence? Much has been written about the different formats and tailored outputs which can be used to ‘increase uptake’ by decision-makers (Lavis et al., 2003 ; Makkar et al., 2016 ; Traynor et al., 2014 )—although not with conclusive findings—yet we know so little about how these messages are received. Researchers may be communicating particularly messages, but how can we be sure that decision-makers are comprehending and interpreting those messages in the same way? Theories of communication (e.g., Levinson, 2000 ; Neale, 1992 ) must be applied to this problem.

Similarly, drawing on psychological theories of behaviour change, commentators have argued for greater use of emotion, narrative and story-telling by researchers in an attempt to influence decision-making (Cairney, 2016b ; Davidson, 2017 ; Jones and Crow, 2017 ). Are these effective at persuading people and if so how do they work? What are the ethical questions surrounding such activities and how does this affect researcher identity? Should researchers be aiming to communicate simple messages about which there is broad consensus?

Discussions of consensus often ask whether agreement is a laudable aim for researchers, or how far consensus is achievable (De Kerckhove et al., 2015 ; Lidskog and Sundqvist, 2004 ; Rescher, 1993 ). We are also interested in the tension between scientific and politician consensus, and how differences in interpretations of knowledge can be leveraged to influence political consensus (Beem, 2012 ; Montana, 2017 ; Pearce et al., 2017 ). What tools can be used to generate credibility? Is evidence persuasive of itself; can it survive the translation process; and is it reasonable to expect individual researchers to broadcast simple messages about which there is broad consensus, if that is in tension with their own ethical practices and knowledge (even if the most effective way to influence policy? Is consensus required for the credibility of science and scientists, or can am emphasis on similarity in fact reduce the value of research and the esteem of the sector? Is it the task of scientists to surface conflicts and disagreements, and how far does this duty extend into the political sphere (Smith and Stewart, 2017 )?

Transforming decision-making, and the role of evidence within it

Finally, we need to understand how research and researchers can support decision-making given what we know about the decision-making context or culture, and how this influences evidence use (Lin, 2008 ). This means better understanding the roles of professional and local cultures of evidence use, governance arrangements, and roles of public dialogues so that we can we start to investigate empirically-informed strategies to increase impact (Locock and Boaz, 2004 ; Oliver et al., 2014 ). This would include empirical examination of individual strategies to influence decision-making, as well as more institutional infrastructures and roles; case studies of different types of policymaking and the evidence diets consumed in these contexts; and how different people embody different imperatives of the evidence/policy nexus. We need to bring together examples of the policy and practice lifecycles, and examine the roles of different types of evidence throughout those processes (Boaz et al., 2011 , 2016 ).

We want to know what shapes the credibility afforded to different experts and forms of expertise, and how to cultivate credibility to enable better decision-making (Grundmann, 2017 ; Jacobson and Goering, 2006 ; Mullen, 2016 ; Williams, 2018 ). What does credibility enable (greater attention or influence; greater participation by researchers in policy processes; a more diverse debate)? What is the purpose of increasing credibility? What is the ultimate aim of attempting to become credible actors in policy spaces? How far should universities and researchers go—should we be always aiming for more influence? Or should we recognise and explore the diversity of roles research and researchers can play in decision-making spaces?

Ultimately, methods must be found to evaluate the impact of evidence on policy and practice change, and on populations—including unintended or unwanted consequences (Lorenc and Oliver, 2013 ; Oliver et al., 2019 , 2019a ). Some have argued that the primary role for researchers is to demonstrate the consequences of decisions and to enable debate. This requires the development and application of methods to evaluate changes, understand mechanisms, and develop theory and substantive and normative debates, as well as engage in the translation and mobilisation of evidence. It also requires increased transparency to enable researchers to understand evidence use (Nesta, 2012 ), while also allowing others like Sense about Science to check the validity of evidence claims on behalf of the public (Sense about Science, 2016 ).

Next steps and concrete outputs

These illustrative examples demonstrate the vast range of discussions which are happening, and need to happen to help us transform how we produce and use evidence. We are not the first to identify the problems of research wastage (Glasziou and Chalmers, 2018 ) or to emphasise the need to maximise the value of research for society (Duncan and Oliver, 2017 ). Nor are we the first to note that all the parts of the research system play a role achieving this, from funding (Geuna and Martin, 2003 ), to research practices (Bishop, 2019 ; Fransman, 2018 ), to translational activities (Boaz et al. 2019 ; Nutley and Tseng, 2014 ), professional science advice (Doubleday and Wilsdon, 2012 ) and public and professional engagement (Holliman and Warren, 2017 ). There have been sustained attempts to build communities and networks to attempt ways to improve parts of this system Footnote 1 . However, most of these initiatives are rooted in particular disciplines or professional activities. We see a need for a network which bridges these initiatives, helping each other articulate their key lessons for one another, and progressing our conversations about how to do better research about evidence production and use.

Researchers, funders, decision-makers and publics will approach and inhabit this space from different, sometimes very different directions. We do not claim to be writing the definitive account. But we would like to open the door to more critical accounts of evidence production and use which are specifically aimed at multi-disciplinary and sectoral audiences. Our aim is to welcome and support debate, to introduce parts of our diverse community to each other, and to enable our individual perspectives and knowledge to be more widely valued.

We anticipate disagreement and discussion, and support a multitude of ways of approaching the issues we identify above. Some may feel that our energies should be directed to democratising knowledge for all and ensuring that this is mobilised to maximise equality and fairness (Stewart et al., 2018 ). Others may feel that our task is to observe, problematise and critique these processes, rather than engage in them directly (Fuller, 1997 ). Our view is that both normative and critical approaches are vital; as are empirical and theoretical contributions to our understanding of high-level research systems, down to micro-interactions in evidence production and use. Our contention is that we must keep this space vibrant and busy, producing new knowledge together, and learning from each other. This requires investment in research on evidence production and use, in virtual and literal spaces to hold conversations, as well as in capacity and capability. There are significant and important gaps in what we know about evidence production and use, but identifying the particular and specific research agendas for each of these gaps must be a collaborative process.

We also see a need to support those who are new to this space. Many come to the problem of evidence use without any training in the history of research in this space. We see a need to provide an accessible route into these debates, and welcome opportunities to collaborate on textbooks or learning resources to support new students, non-academics and those new to the field.

The Nuffield Foundation meeting which led to this paper demonstrated how valuable these opportunities are to enable learning and relationship-building through face-to-face interactions. We will continue to create opportunities for greater transdisciplinary and academic-partner conversations, to share learning across spheres of activity and to build capacity, and to use these new perspectives to generate fresh avenues of enquiry, through the new Transforming Evidence Footnote 2 collaboration.

Finally, we argue for increased investment to maximise the learning we already have, and to support more effective knowledge production and use. Too much money and expertise has been wasted, and too many opportunities to build on existing expertise have been squandered. We must find better ways to make this learning accessible, and to identify true knowledge gaps. Indeed, we believe that collaboration across disciplinary and sectoral boundaries is the only way in which this space will both progress and demonstrate its true value. We must prevent the waste of limited resources to understand how to transform evidence production and use for the benefit of society. Putting what we already know into practice would be an excellent place to start.

Change history

29 august 2019.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

See, for example https://www.alliance4usefulevidence.org/ , https://www.ingsa.org/ , https://4sonline.org/ , https://www.metascience2019.org/ , http://www.alltrials.net/

See Transforming Evidence site, https://transformure.wordpress.com/

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Acknowledgements

We thank the Nuffield Foundation, the Wellcome Trust and the William T Grant Foundation for financial support for a meeting on Transforming the use of Research Evidence, held in London in 2018. We are grateful to both the participants at this meeting and those attending the William T Grant Foundation Use of Research Evidence meeting in Washington 2019. In particular, we very much appreciate the contribution of Kim DuMont, Paul Cairney and Warren Pearce who commented on drafts of this paper before submission. Our thanks to you all.

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News Release

Tuesday, June 15, 2021

NIH study offers new evidence of early SARS-CoV-2 infections in U.S.

A new antibody testing study examining samples originally collected through the National Institutes of Health’s All of Us Research Program found evidence of SARS-CoV-2 infections in five states earlier than had initially been reported. These findings were published in the journal Clinical Infectious Diseases . The results expand on findings from a Centers for Disease Control and Prevention study that suggested SARS-CoV-2, the virus that causes COVID-19, was present in the U.S. as far back as December 2019.

In the All of Us study, researchers analyzed more than 24,000 stored blood samples contributed by program participants across all 50 states between Jan. 2 and March 18, 2020. Researchers detected antibodies against SARS-CoV-2 using two different serology tests in nine participants’ samples. These participants were from outside the major urban hotspots of Seattle and New York City, believed to be key points of entry of the virus in the U.S. The positive samples came as early as Jan. 7 from participants in Illinois, Massachusetts, Mississippi, Pennsylvania and Wisconsin. Most positive samples were collected prior to the first reported cases in those states, demonstrating the importance of expanding testing as quickly as possible in an epidemic setting.

“This study allows us to uncover more information about the beginning of the U.S. epidemic and highlights the real-world value of longitudinal research in understanding dynamics of emerging diseases like COVID-19,” said Josh Denny, M.D., M.S., chief executive officer of All of Us and an author of the study. “Our participants come from diverse communities across the U.S. and give generously of themselves to drive a wide range of biomedical discoveries, which are vital for informing public health strategies and preparedness.”

In studies like these, false positives are a concern, particularly when the prevalence of viral infections is low, as was the case in the early days of the U.S. epidemic. Researchers in this study followed CDC guidance to use sequential testing on two separate platforms to minimize false positive results.

All of Us worked with Quest Diagnostics to test samples on the Abbott Architect SARS-CoV-2 IgG ELISA and the EUROIMMUN SARS-CoV-2 ELISA (IgG) platforms. For a sample to be considered “positive” by the research team, it had to have positive results on both platforms, which target antibodies that bind to different parts of the virus. Both tests have emergency use authorization from the FDA.

“Antibody testing of blood samples helps us better understand the spread of SARS-CoV-2 in the U.S. in the early days of the U.S. epidemic, when testing was restricted and public health officials could not see that the virus had already spread outside of recognized initial points of entry,” said Keri N. Althoff, Ph.D., lead author and associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore. “This study also demonstrates the importance of using multiple serology platforms, as recommended by the CDC.”

Antibodies are proteins produced in the blood in response to an infection, such as a virus. They play a critical role in fighting infections and are helpful signs that a person may have been exposed to an infection in the past, even if they didn’t show symptoms. In the All of Us study, researchers looked in participant samples for a type of antibodies called IgG. These antibodies do not appear until about two weeks after a person has been infected, indicating that participants with these antibodies were exposed to the virus at least several weeks before their sample was taken. In this study, the first positive samples came from participants in Illinois and Massachusetts on Jan. 7 and 8, 2020, respectively, suggesting that the virus was present in those states in late December.

The study authors noted several limitations to their study. While the study included samples from across the U.S., the number of samples from many states was low. In addition, the authors do not know whether the participants with positive samples became infected during travel or while in their own communities. Ideally, this study could be replicated in other populations with samples collected in the initial months of the U.S. epidemic and with multiple testing platforms to compare results.

All of Us expects to release more information following further analysis, and will offer participants whose samples were included in the study an opportunity to receive their individual results. The presence of antibodies in one’s blood sample does not guarantee that a person is protected from the infection (has immunity), or that any such protection will last.

Deidentified data from the antibody tests will be accessible to researchers for follow-up studies in a future release of the All of Us data analysis platform, the Researcher Workbench, with privacy and security safeguards in place. Currently, the Researcher Workbench includes data from more than 315,000 participants, including information from surveys, electronic health records, wearable devices and more. For full details about data access, visit ResearchAllofUs.org .

The study was supported by All of Us and the National Cancer Institute.

About the All of Us Research Program: The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. The program will partner with one million or more people across the United States to build the most diverse biomedical data resource of its kind, to help researchers gain better insights into the biological, environmental, and behavioral factors that influence health. For more information, visit www.JoinAllofUs.org and https://www.allofus.nih.gov/ .

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov .

NIH…Turning Discovery Into Health ®

Althoff KN, et al, “Antibodies to SARS-CoV-2 in All of Us Research Program Participants,” January 2-March 18, 2020,  Clinical Infectious Diseases , 2021;  https://academic.oup.com/cid/article-lookup/doi/10.1093/cid/ciab519

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New research offers possible cause for long COVID

Pieces of the COVID virus can lurk in our blood and tissue for more than a year after the initial illness has vanished, a discovery that might offer clues to the mystery of lingering post-infection disability, according to new research from UC San Francisco.

Four years after the U.S. went into lockdown, the worst of the pandemic has passed. But for people with long COVID, the illness remains a daily misery.

The new research suggests why: The virus is not always fully cleared after the initial infection, so remains embedded, even though people are no longer contagious.

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It is not yet known if these small viral proteins, called antigens, are causing long COVID. But, based on the new discovery, the UCSF team is conducting clinical trials of potential therapies that could attack the hidden pathogen.

“There is a lot more work to be done, but I feel like we are making progress in really understanding the long-term consequences of this infection,” said infectious disease expert Dr. Michael Peluso, who presented the research at last week’s Conference on Retroviruses and Opportunistic Infections.

While COVID remains much more serious than the usual seasonal flu, safe and highly effective vaccines have caused a dramatic decline in infections and deaths.

There is a desperate need for a diagnostic test and treatment for long COVID, which affects an estimated 7% of American adults. Currently, doctors are only treating the symptoms, rather than offering a cure. Experts predict that the disorder will place continuing demands on our health care system.

“Long COVID patients deserve swift, accurate diagnosis and timely, effective treatment,” said Jaime Seltzer, scientific director at the nonprofit MEAction, which advocates for patients with long COVID and myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS.

Is the clandestine virus constantly provoking the immune system, causing symptoms? That’s one leading theory. Another possibility is that COVID triggers an autoimmune response when the body mistakenly attacks itself. Or perhaps, long after it fends off infection, the immune system fails to turn off.

Using an ultrasensitive test of blood from 171 people who had been infected with COVID, the UCSF scientists found pieces of the viral “spike” protein that persisted up to 14 months after infection.

They discovered that the likelihood of detecting the protein was about twice as high in people who had been severely ill, requiring hospitalization, than those who were not. Detection was also higher in the blood of people who reported being very sick but were not hospitalized.

In tissue samples, traces of the virus were found up to two years after infection. It was hidden in connective tissue where immune cells are located.

The work was conducted at UCSF’s Long COVID Tissue Bank, the world’s first tissue bank with samples donated by patients with long COVID.

It provides some of the strongest evidence so far that COVID antigens can persist in some people, according to Peluso.

“The UCSF team includes people who helped make HIV and AIDS a treatable disease,” according to Amy Proal, president of PolyBio, a research foundation focused on long COVID. “These researchers rapidly pivoted into long COVID research at the outset of the pandemic, leveraging years of experience performing similar research with patients with HIV and AIDS.”

Persistent COVID infections — caused by actively replicating virus — were recently reported in another study based on a large community surveillance project in the United Kingdom. It found that 1% to 3% of people had persistent infections for more than 30 days and 0.1% to 0.5% had them for more than 60 days.

This is worrisome because these persistent active infections may act as viral “reservoirs” that lead to new and highly genetically divergent lineages, seeding a future outbreak.

That study found that the risk of long COVID was 55% higher in people with persistent infection.

“We’re making considerable headway on understanding what drives long COVID,” wrote Dr. Eric Topol, director of the Scripps Research Translational Institute in La Jolla.

“Clearly finding effective and safe treatments is an urgent matter and not enough is being done to pursue that yet, despite a long list of potential alluring interventions based on mechanistic insights,” he said. “Hopefully that will get going now — it cannot happen soon enough.”

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New research offers clues to what causes long COVID — fuelling hope for eventual treatments

Different research teams have identified multiple hallmarks of the often-debilitating condition.

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This story is part of CBC Health's Second Opinion, a weekly analysis of health and medical science news emailed to subscribers on Saturday mornings. If you haven't subscribed yet, you can do that by clicking here .

For several years, scientists have tried to untangle one of COVID-19's persistent puzzles: Why do some people, even after mild infections, go on to develop lasting health issues? And crucially: How do you prevent, treat or even cure those lingering symptoms?

Now, fresh clues are emerging. Several research teams have honed in on potential hallmarks of long COVID, formally known as post-COVID-19 condition , offering insight into the possible mechanisms at play. 

Other researchers, meanwhile, are finding overlaps between long COVID and the persistent symptoms some people experience after other types of infections, from influenza to the common cold — suggesting there may be similar triggers for a wide range of little-understood conditions.

There are no smoking guns yet. Still, emerging research could bring scientists one step closer to figuring out treatments to ward off post-infection symptoms ranging from debilitating exhaustion to life-altering "brain fog."

"We're getting the sense that there are some tangible mechanisms that can produce some of these symptoms," said Christoph Thaiss, an assistant professor of microbiology at the University of Pennsylvania's Perelman School of Medicine. 

"And many of them might actually be, surprisingly, shared among many of these conditions."

WATCH | Research suggests most long COVID symptoms clear up within a year:

Most long COVID symptoms clear up within a year, new research suggests

Studies point to long covid biomarkers.

Two recent studies have tried to tease out long COVID biomarkers — traits in someone's blood, tissues or bodily fluids that can be measured and tracked, at times offering signals of an infection or disease. (Blood pressure and high cholesterol, for instance, are both common biomarkers physicians analyze at routine medical appointments.)

One new paper, from Thaiss and others at the University of Pennsylvania, was published on Monday in the journal Cell . It looked at both real-world patients — some with long COVID, others who fully recovered — and animal models.

Their research suggests the release of interferons — a group of signalling proteins that cells send out as an alert system when there's a viral threat — could drive the depletion of a key chemical messenger, serotonin. In turn, that may lead to cognitive impacts such as memory issues or a feeling of "brain fog."

The team was surprised to find that some people with long COVID still had virus fragments lingering in their guts, long after they were no longer testing positive for the virus. Those particles, located through stool samples, might be enough to trigger the release of interferons. 

WATCH | COVID-19 infections rising again:

New COVID-19 vaccines rolling out slowly as cases rise

That could set off a chain reaction, leading to inflammation that makes it tougher for the digestive system to absorb tryptophan — an essential amino acid found in food that helps the body make serotonin. 

During long COVID, it seems the "peripheral pool of serotonin is depleted, while the brain pool of serotonin is untouched," said Thaiss. And when serotonin elsewhere in the body dries up, it can disrupt crucial parts of the nervous system. (Scientists still don't fully understand how serotonin works, but low levels have previously been linked to depression, along with sleep and digestive issues.)

This new research follows another recent biomarker study from a team led by Yale University immunologist Akiko Iwasaki. That paper, published by Nature , involved a comparison of three groups: people with long COVID, those who were infected around the same time but fully recovered, and those who have never had COVID.

The team found differences in blood samples that distinguished long COVID patients from the others, including exhausted immune cells and lower levels of cortisol, a hormone that regulates a wide variety of bodily processes including metabolism and immune response. 

• Second Opinion Researchers are still untangling the risks of catching COVID over and over

Iwasaki's team also noticed the reactivation of dormant Epstein-Barr virus (EBV) in long COVID patients. This common pathogen can cause mononucleosis (also known as mono) but also infects most people at least once in their lifetime, usually without any symptoms.

"So now we're kind of thinking that could be indicative of a person's immune response being dampened by the COVID infection, allowing these latent viruses to become reactivated," she said. "It's also possible that [this] reactivated EBV can be leading to some of the symptoms."

Research still in 'early days'

In some ways, these efforts to identify biomarkers are raising more questions than answers. But infectious diseases specialist Dr. William Schaffner, from the Vanderbilt University Medical Center in Nashville — who wasn't involved in either study — says they do shine a spotlight on potential mechanisms at play.

The question now, he said, is: "Why is it that some people can't turn off the inflammatory response and it continues to smolder, causing this collateral damage?"

• Second Opinion Long COVID may now be less common than previously thought

It's still "early days" when it comes to answering that question, Schaffner added, because the latest published studies are fairly small and narrow in scope, based on researchers' areas of expertise. 

"These various studies seem to complement each other," he added, "even though they're not exactly duplicative."

Schaffner and others are hopeful, however, that these kinds of emerging findings could eventually lead to a diagnostic test for long COVID, or to potential treatments.

• Long COVID among medical workers may have 'profound' impact on health care, study suggests

The study zeroing in on serotonin, for instance, points to existing medications — selective serotonin reuptake inhibitors (SSRIs), a class of drugs most commonly prescribed to treat depression — as one area for future research.

"The million-dollar question is whether we can treat individuals or ameliorate their symptoms by targeting this pathway — either by restoring serotonin levels, through tryptophan supplementation or through the usage of SSRIs, or by eradicating their viral reservoir," said Thaiss.

Long COVID overlaps with other conditions

The latest studies come at a time when rates of long COVID appear to be dropping . That's thanks, in part, to widespread use of COVID vaccines, because vaccination appears to lower the risk of developing the condition, according to various studies . 

But the condition still impacts millions around the world — with a broad range of symptoms and severity — and many scientists say untold numbers of people likely suffered similar ailments after other types of viral or bacterial infections, long before COVID hit.

New research from the U.K. published earlier this month in The Lancet's eClinicalMedicine suggests SARS-CoV-2 isn't the only respiratory virus that can lead to lasting symptoms after someone gets through an initial infection.

• Second Opinion Long COVID symptoms resolve in a year for most mild infections, study finds

The research team analyzed data from more than 10,000 adults and found evidence of lingering health issues following influenza and common cold infections as well, with some symptoms that overlapped with long COVID and some distinct differences. 

Long COVID was linked more often to dizziness and issues with someone's sense of taste or smell, for instance, while lingering symptoms after a cold were more likely to include gastrointestinal issues. 

"The fact that we found some similarities and a few differences to me really indicates that different infections will be able to lead to different sorts of symptoms, and when there's overlap, we'll be dealing with a similar mechanism in the end," said Giulia Vivaldi, a statistician and epidemiologist at Queen Mary University of London who is working on the COVIDENCE U.K. study, a prospective population-based look at respiratory infections.

• Common, inexpensive diabetes drug could cut long COVID risk, study finds

Iwasaki, from Yale, said the findings were not particularly surprising, and agreed with the research team's conclusion that post-infection health impacts deserve far more scrutiny, beyond just long COVID.

"We don't really know the frequency of how other types of viruses lead to post-acute infection syndrome," she said.

"So that's something that we need to study further."

'We could go back to having a life'

One of the Canadians still grappling with long COVID, Montreal physician Dr. Anne Bhéreur, agreed there are likely various conditions with common links, be it lingering symptoms after certain bacterial infections or the largely unexplained and disabling condition myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

WATCH | Researchers study long COVID in health workers:

Quebec researchers study Long COVID among health-care workers

Bhéreur has faced an array of symptoms since she had COVID in late 2020, including shortness of breath, difficulty speaking, nausea, dizziness and extreme fatigue.

Various interventions and medications have improved her condition over the years, Bhéreur said, but it's far from a cure. Even now, over-exertion can bring all her worst symptoms back, years after her initial infection. 

• Analysis COVID keeps evolving, but so does our immunity. Are we now at a 'stalemate' with this virus?
• Top medical experts call for national inquiry into Canada's COVID-19 'failures'

Still, she's hopeful that ongoing research will bring scientists closer to an actual treatment for the root causes of conditions like hers, and potentially other post-infectious illnesses that she says have long been "utterly neglected." 

It could be decades before patients get results, Bhéreur noted — she cited  one study suggesting it's an average of 17 years between research and clinical changes — but she said if momentum holds up, there's hope for a treatment game-changer.

"Knowing that they could treat the root cause, that we could reverse what's going on, would also mean we could go back to having a life," she said.

ABOUT THE AUTHOR

Senior Health & Medical Reporter

Lauren Pelley covers health and medical science for CBC News, including the global spread of infectious diseases, Canadian health policy, pandemic preparedness, and the crucial intersection between human health and climate change. Two-time RNAO Media Award winner for in-depth health reporting in 2020 and 2022. Contact her at: [email protected]

• @LaurenPelley

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Can ethics be taught? New research from MIT Sloan and Notre Dame offers first large sample evidence on how ethics training affects behavior and employment decisions in the financial sector

MIT Sloan Office of Communications

Nov 18, 2019

Cambridge, Mass., November 18, 2019— Can ethics be taught? Evidence points towards yes, according to new research that offers the first large sample study on how rules and ethics training affects behavior and employment decisions in the financial sector.

The authors are Andrew G. Sutherland , Associate Professor of Accounting at the MIT Sloan School of Management; Zach Kowaleski , Assistant Professor of Accounting at the University of Notre Dame’s Mendoza College of Business; and Felix Vetter , a PhD candidate at the London School of Economics.

The researchers studied nearly 1.2 million investment advisers and financial representatives working at U.S. broker-dealers between 2007 and 2017, with a focus on the consequences of a 2010 change in the investment adviser qualification exam. That year, questions from the rules and ethics section were reallocated to the technical material section. The rules and ethics section covers allowable forms of compensation, disclosure requirements, and prohibitions of unethical business practices while the technical section covers such topics as capital market theory, investment vehicle characteristics, ratios, and financial reporting. Prior to the change, rules and ethics questions received an 80% weight, whereas after their weight was just 50%.

The authors’ analysis effectively compares individuals who took different versions of the exam but are otherwise similar in terms of their current employer, location, qualifications, and experience.

Their main finding is that those passing the older exam, with more rules and ethics coverage, were one-fourth less likely to commit misconduct. A similar pattern appears for egregious misconduct—incidents involving fraud, theft, or deception—indicating the exam alters individuals’ perception of acceptable conduct (i.e., ethics) and not just their awareness of specific rules.

In terms of individual characteristics, they found the behavior of the least experienced advisers is most sensitive to the extent of rules and ethics testing. These results are consistent with the exam playing a “ priming ” role, where early exposure to rules and ethics material prepares the individual to behave appropriately later. Those passing the exam without prior misconduct appear to respond most to the amount of rules and ethics material covered on their exam. Those already engaging in misconduct, or having spent several years working in the securities industry, respond least or not at all.

As for firm characteristics, the researchers found the exam’s coverage to be less pertinent to those advisers working at firms where misconduct is prevalent. Thus, the contagion of misconduct behavior appears to limit the effectiveness of training in preventing transgressions.

Further, those advisers passing the older exam were more likely to leave employers experiencing a firm-wide spike in misconduct and financial sanctions. Such departures, the researchers noted, are also an early warning sign of future misconduct and sanctions at the firm.

The exam is administered by the Financial Industry Regulatory Authority (FINRA) and designed by the North American Securities Administrators Association (NASAA) .

“Advisers play an important role in helping households access financial markets, and represent one of the largest financial sector occupations in the United States. The exam appears to affect advisers’ perception of acceptable conduct, and not just their awareness of specific rules or selection into the qualification,” says Prof. Sutherland. “In this context, ethics training can affect an individual’s behavior by increasing the value of their reputation, as well as the psychological costs of committing misconduct.”

To access the research paper, Can Ethics be Taught? Evidence from Securities Exams and Investment Adviser Misconduct , please visit: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3457588

About the MIT Sloan School of Management

The MIT Sloan School of Management is where smart, independent leaders come together to solve problems, create new organizations, and improve the world. Learn more at mitsloan.mit.edu .

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What is Proof of Concept Research and how does it Generate Epistemic and Ethical Categories for Future Scientific Practice?

• Original Paper
• Published: 26 May 2015
• Volume 22 , pages 735–753, ( 2016 )

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• Catherine Elizabeth Kendig   ORCID: orcid.org/0000-0001-8865-2924 1  

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“Proof of concept” is a phrase frequently used in descriptions of research sought in program announcements, in experimental studies, and in the marketing of new technologies. It is often coupled with either a short definition or none at all, its meaning assumed to be fully understood. This is problematic. As a phrase with potential implications for research and technology, its assumed meaning requires some analysis to avoid it becoming a descriptive category that refers to all things scientifically exciting. I provide a short analysis of proof of concept research and offer an example of it within synthetic biology. I suggest that not only are there activities that circumscribe new epistemological categories but there are also associated normative ethical categories or principles linked to the research. I examine these and provide an outline for an alternative ethical account to describe these activities that I refer to as “extended agency ethics”. This view is used to explain how the type of research described as proof of concept also provides an attendant proof of principle that is the result of decision-making that extends across practitioners, their tools, techniques, and the problem solving activities of other research groups.

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The Roadmap to Research: Fundamentals of a Multifaceted Research Process

New Debates in Old Ethical Skins

Ethical Issues in Research Methods

Despite its prominent use and description within synthetic biology and biological engineering, the notion of proof of concept research is not restricted to these and has been used in other fields of research as well.

One of the more lengthy definitions can be found in the National Science Foundation’s Program Solicitation: Accelerating Innovation Research - Technology Translation from the Directorate for Engineering, Industrial Innovation and Partnerships: “A proof-of-concept is the realization of a certain method or idea to ascertain its scientific or technological parameters. A proof-of-concept should be understood sufficiently so that potential application areas can be identified and a follow-on working prototype designed.” (National Science Foundation 2014 , 14-569).

In this, I apply Clark’s ( 1995 , 1998 , 2010 ; and Clark and Chalmers 1998 ) extended mind thesis to normative valuational claims in ethics.

In 2014, the U.S. Patent and Trademark Office provided the Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena and Natural Products (Hirshfeld 2014 ). In this, a balancing test was suggested to decide whether a claim is “significantly different” from that which is made to be a judicial exception to patentability. That is, whether that which is to be patented has been changed sufficiently to make it different from the naturally occurring phenomena or product. But, of course, the decidability of “significantly different” is decidable only with regard to knowledge of what it is different-from, or different-in-what-way to. Like the 2013 decision, this assumes products of nature and products of humans are ontological distinct and arbitrable.

It should be noted that this concern is premised on a misunderstanding of the nature of being in two ways. Novelty is endemic in both reproduction and development. That an organism never existed cannot on its own be a source for concern as each new organism that comes into being (through either sexual or asexual reproduction) never existed before and so is in some sense the first of its kind. Further, organisms constantly change their cellular, epigenetic, and physiological makeup throughout their lifetime (cf. Kendig 2014b ).

It should be recognized that this aesthetic response is not one that is universally shared. There is a wide variability of responses to these entities that goes largely unanalyzed in the discussion of the “yuck” factor. The diversity of responses can be the result of one’s training, scientific discipline, or culture. The upshot? Those moral intuitions perceived to follow from the aesthetic response of liminality-avoidance are also not universally shared.

Of course the subverting of natural categories has had a long history in selective breeding in agriculture, horticulture, and among pet breeders as well.

This is not to discount the role of thought experiments or the use of literary narratives (such as those played out in science fiction). The later discussion of extended agency ethics would suggest that these could play a role but their role would be shared with articulated network of agents involved within the system.

Doing so would be to assume a false dichotomy that suggests one must either be wholly for or wholly against technology of all types.

This is usually discussed in the context of the inadmissibility of claiming an ought from an is (the naturalistic fallacy).

This could be seen as a new application of Robert Wilson’s ( 2004 , 2005 ) social manifestation thesis.

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Acknowledgments

Research for this project was funded by the National Science Foundation Division of Molecular and Cellular Biosciences (MCB), BIOMAPS: Modular Programmed Evolution of Bacteria for Optimization of Metabolic Pathways, Grant No. MCB-1329350, Research Opportunity Award: "How synthetic biology reconfigures biological and bioethical categories", Amendment No. 001, Proposal No. MCB-1417799.

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Kendig, C.E. What is Proof of Concept Research and how does it Generate Epistemic and Ethical Categories for Future Scientific Practice?. Sci Eng Ethics 22 , 735–753 (2016). https://doi.org/10.1007/s11948-015-9654-0

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Trial is just around the corner, and you’re feeling confident. You have critical text messages that demonstrate your opponent’s theory of the case is not to be believed. You have a witness lined up to authenticate the messages and explain their meaning, namely your party opponent. But before the start of trial, the court grants your opponent’s motion in limine on relevancy grounds. The evidence is not coming in. The case you were excited to try has just become unwinnable. What do you do?

You can’t file an interlocutory appeal because limine rulings don’t qualify. See Tex. Civ. Prac. & Rem Code § 51.014 (statutorily-authorized interlocutory appeals). You can’t mandamus your judge because mandamus is only available when there is no adequate remedy by appeal. In this situation, you can re-offer the evidence at trial, and if the court rules it excluded, you have a remedy by appeal, that is, if you properly preserve error. See Reveal v. West , 764 S.W.2d 8, 10 (Tex. App.—Houston [1st Dist.] 1988, no writ) (mandamus unavailable in limine context). And that brings us to the point of this article, mastering the offer of proof .

When the trial court makes an erroneous ruling excluding evidence, to preserve error on appeal, the record must demonstrate (i) you offered the evidence during trial; (ii) you secured a ruling; and (iii) the actual content and significance of the evidence. See Veale v. Teledyne Industries, Inc ., 899 S.W.2d 239, 242 (Tex. App.—Houston [14th Dist.] 1995, writ denied). Even then, the court of appeals will only reverse if the evidentiary ruling was harmful, that is, it probably caused the rendition of an improper judgment based on the court of appeals’ review of the record as a whole. See Gunn v. McCoy , 554 S.W.3d 645, 668 (Tex. 2018). But if the trial court excluded the evidence from the record, how do you ensure it becomes part of the record when the case goes up on appeal?

Texas Rules of Evidence 103(a)(2) states: “A party may claim error in a ruling to admit or exclude evidence only if the error affects a substantial right of the party and . . . if the ruling excludes evidence, a party informs the court of its substance by an offer of proof , unless the substance was apparent from the context.” Tex. R. Evid. 103(a)(2) (emphasis added). Rule 103(a)(c) further states: “The court must allow a party to make an offer of proof outside the jury’s presence as soon as practicable—and before the court reads its charge to the jury.”). Tex. R. Evid. 103(a)(c). Importantly, “[t]he right to make an offer of proof is absolute.” Andrade v. State , 246 S.W.3d 217, 226 (Tex. App.—Houston [14th Dist.] 2007, pet. denied) (citing Kipp v. State , 876 S.W.2d 330, 333 (Tex. Crim. App. 1994) ). 

In our hypothetical, because the limine ruling is not sufficient to preserve error for appeal, you must, during trial, first offer the evidence and obtain a ruling. See Southwest Country Enterprises v. Lucky Lady Oil Company , 991 S.W.2d 490, 493 (Tex. App.—Fort Worth 1999, pet. denied). Since the court granted the motion in limine, at the appropriate time in your case, ask the judge for permission to approach. Inform the judge that you are mindful of the limine ruling but you request the court to reconsider. Assuming the court does not reconsider, formally offer the text messages into evidence, and when your opponent objects, specify the purpose of the messages and why they are relevant. If the judge excludes them, secure a ruling on the record, and tell the judge that you must exercise your right to make an offer of proof outside the jury’s presence to preserve error for appeal. 

When the jury is excused, you must decide how to present your offer of proof.  You, as the attorney, have the option of describing and summarizing the excluded evidence with enough specificity to enable the court of appeals to decide whether the court’s ruling was erroneous. See Wattas v. Oliver , 396 S.W.3d 124, 129 (Tex. App.—Houston [14th Dist.] 2013, no pet.) (“The offer of proof may be made by counsel, who should reasonably and specifically summarize the evidence offered and state its relevance, unless already apparent. If counsel makes such an offer, he must describe the actual content of the testimony and not merely comment on the reasons for it.”).

If you choose this manner, tell the judge what, specifically, the text messages say, what, specifically, the party opponent is expected to testify, including the basis of the witness’s personal knowledge, and explain in detail why the evidence is relevant. Additionally, make sure you introduce any documents or exhibits during the offer of proof along with the narrative on the record before the court reporter so that it will be included in the clerk’s record and the reporter’s record.

Alternatively, the offer of proof must be conducted in question and answer format upon “a party’s request”—which includes your opponent’s—or the court’s request. See Tex. R. Evid. 103(c). As one commentator observes: “A proponent may prefer the question-and-answer form to eliminate doubt as to the harm caused by the exclusion, and possibly to encourage the trial judge to reconsider the ruling.  An opponent, on the other hand, may prefer the question-and-answer form in order to ‘call the bluff’ of a proponent whose informal summary may be optimistic.” 1 Tex. Prac., Texas Rules of Evidence § 103.5 (4th Ed.).

If you think the judge may reconsider the ruling after listening to the witness testify about the text messages, it may be wise to choose this option. And regardless, it is good advice to have your questions and exhibits prepared just in case the judge or your opponent request this option.

When you have concluded your offer of proof, ask the judge to reconsider the ruling and admit the excluded evidence. Secure the judge’s ruling on the record. Then, make a statement that the offer of proof and the text messages be included in the court reporter’s record, separately identified as the offer of proof. The court of appeals will now know what transpired at trial, what the excluded evidence would show, and have a sufficient basis to reverse and remand if the ruling was erroneous and harmful.

AmyJo "AJ" Foreman is an associate in the litigation section. Her practice focuses primarily on commercial litigation, labor & employment, and appellate matters.

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Steve Knight is a Shareholder in the Houston Litigation group and is Co-Chair of the Appellate Law section.

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Inexpensive, Accessible Device Provides Visual Proof that Masks Block Droplets

DURHAM, N.C. – Duke physician Eric Westman was one of the first champions of masking as a means to curtail the spread of coronavirus, working with a local non-profit to provide free masks to at-risk and under-served populations in the greater Durham community.

But he needed to know whether the virus-blocking claims mask suppliers made were true, to assure he wasn’t providing ineffective masks that spread viruses along with false security. So he turned to colleagues in the Duke Department of Physics : Could someone test various masks for him? 

Martin Fischer , Ph.D., a chemist and physicist, stepped up. As director of the Advanced Light Imaging and Spectroscopy facility, he normally focuses on exploring new optical contrast mechanisms for molecular imaging, but for this task, he MacGyvered a relatively inexpensive apparatus from common lab materials that can easily be purchased online. The setup consisted of a box, a laser, a lens, and a cell phone camera. 

In a proof-of-concept study appearing online Aug. 7 in the journal Science Advances , Fischer, Westman and colleagues report that the simple, low-cost technique provided visual proof that face masks are effective in reducing droplet emissions during normal wear.

“We confirmed that when people speak, small droplets get expelled, so disease can be spread by talking, without coughing or sneezing,” Fischer said. “We could also see that some face coverings performed much better than others in blocking expelled particles.”

Notably, the researchers report, the best face coverings were N95 masks without valves – the hospital-grade coverings that are used by front-line health care workers. Surgical or polypropylene masks also performed well.

But hand-made cotton face coverings provided good coverage, eliminating a substantial amount of the spray from normal speech.

On the other hand, bandanas and neck fleeces such as balaclavas didn’t block the droplets much at all.

“This was just a demonstration - more work is required to investigate variations in masks, speakers, and how people wear them – but it demonstrates that this sort of test could easily be conducted by businesses and others that are providing masks to their employees or patrons,” Fischer said.

“Wearing a mask is a simple and easy way to reduce the spread of COVID-19,” Westman said. “About half of infections are from people who don’t show symptoms, and often don’t know they’re infected. They can unknowingly spread the virus when the cough, sneeze and just talk.

“If everyone wore a mask, we could stop up to 99% of these droplets before they reach someone else,” Westman said. “In the absence of a vaccine or antiviral medicine, it’s the one proven way to protect others as well as yourself.”

Westman and Fischer said it’s important that businesses supplying masks to the public and employees have good information about the products they’re providing to assure the best protection possible.

“We wanted to develop a simple, low-cost method that we could share with others in the community to encourage the testing of materials, masks prototypes and fittings,” Fischer said. “The parts for the test apparatus are accessible and easy to assemble, and we’ve shown that they can provide helpful information about the effectiveness of masking.”

Westman said he put the information immediately to use: “We were trying to make a decision on what type of face covering to purchase in volume, and little information was available on these new materials that were being used.”

The masks that he was about to purchase for the “Cover Durham” initiative? 

“They were no good,” Westman said. “The notion that ‘anything is better than nothing’ didn’t hold true.”

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New DNA Research Changes Origin of Human Species

By University of California - Davis May 18, 2023

A new model for human evolution asserts that modern Homo sapiens stemmed from multiple genetically diverse populations across Africa rather than a single ancestral population. This conclusion was reached after researchers analyzed genetic data from present-day African populations, including 44 newly sequenced genomes from the Nama group of southern Africa. The research suggests that the earliest detectable split in early human populations occurred between 120,000 to 135,000 years ago, after long periods of genetic intermixing, and that subsequent migrations created a weakly structured genetic stem. Contrary to some previous models, this research implies that contributions from archaic hominins were unlikely to have significantly affected Homo sapiens’ evolution.

New model for human evolution suggests Homo sapiens arose from multiple closely related populations.

A new study in Nature challenges prevailing theories, suggesting that Homo sapiens evolved from multiple diverse populations across Africa, with the earliest detectable split occurring 120,000-135,000 years ago, after prolonged periods of genetic intermixing.

In testing the genetic material of current populations in Africa and comparing it against existing fossil evidence of early Homo sapiens populations there, researchers have uncovered a new model of human evolution — overturning previous beliefs that a single African population gave rise to all humans. The new research was published on May 17, in the journal Nature .

Although it is widely understood that  Homo sapiens  originated in Africa, uncertainty surrounds how branches of human evolution diverged and how people migrated across the continent, said Brenna Henn, professor of anthropology and the Genome Center at UC Davis, corresponding author of the research.

View of the village of Kuboes, on the border of South Africa and Namibia. DNA samples were collected from Nama individuals who have historically lived in the region. Credit: Brenna Henn/UC Davis

“This uncertainty is due to limited fossil and ancient genomic data, and to the fact that the fossil record does not always align with expectations from models built using modern DNA ,” she said. “This new research changes the origin of species .”

Research co-led by Henn and Simon Gravel of McGill University tested a range of competing models of evolution and migration across Africa proposed in the paleoanthropological and genetics literature, incorporating population genome data from southern, eastern, and western Africa.

Nama woman standing in the doorway to her home in Kuboes, South Africa, a UNESCO World Heritage Site. Credit: Justin Myrick-Tarrant/with permission

The authors included newly sequenced genomes from 44 modern Nama individuals from southern Africa, an Indigenous population known to carry exceptional levels of genetic diversity compared to other modern groups. Researchers generated genetic data by collecting saliva samples from modern individuals going about their everyday business in their villages between 2012 and 2015.

The model suggests the earliest population split among early humans that is detectable in contemporary populations occurred 120,000 to 135,000 years ago, after two or more weakly genetically differentiated  Homo  populations had been mixing for hundreds of thousands of years. After the population split, people still migrated between the stem populations, creating a weakly structured stem. This offers a better explanation of genetic variation among individual humans and human groups than do previous models, the authors suggest.

“We are presenting something that people had never even tested before,” Henn said of the research. “This moves anthropological science significantly forward.”

“Previous more complicated models proposed contributions from archaic hominins, but this model indicates otherwise,” said co-author Tim Weaver, UC Davis professor of anthropology. He has expertise in what early human fossils looked like and provided comparative research for the study.  

The authors predict that, according to this model, 1-4% of genetic differentiation among contemporary human populations can be attributed to variation in the stem populations. This model may have important consequences for the interpretation of the fossil record. Owing to migration between the branches, these multiple lineages were probably morphologically similar, which means morphologically divergent hominid fossils (such as  Homo naledi ) are unlikely to represent branches that contributed to the evolution of  Homo sapiens , the authors said.

For more on this research, see DNA Reveals a New Twist in Human Origin Story .

Reference: “A weakly structured stem for human origins in Africa” by Aaron P. Ragsdale, Timothy D. Weaver, Elizabeth G. Atkinson, Eileen G. Hoal, Marlo Möller, Brenna M. Henn and Simon Gravel, 17 May 2023, Nature . DOI: 10.1038/s41586-023-06055-y

Additional co-authors include Aaron Ragsdale, University of Wisconsin, Madison; Elizabeth Atkinson, Baylor College of Medicine; and Eileen Hoal and Marlo Möller, Stellenbosch University, South Africa.

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115 comments on "new dna research changes origin of human species".

The title and writing in this article will mislead people. It’s a poorly worded piece that will lead to misunderstandings in a large part of the uneducated public. This research doesn’t “change the origin of species”. It has always been assumed that multiple interbreeding human populations were in our lineage. This research simply confirms that which other research pointed to already. Mark my words, this will bring all the nut job creationists out of the woodwork.

Do creationists even read SciTechDaily? Been on this site for a few years and can count the number of Bible-thumper-arguements on one hand.

And yet, even with your bombastic intellect, you still can’t spell “argument.”

Is that the best you can do, Cleeeeeetus? XD

You probably looked up how to spell argument and made fun of this fellow. What a freaking idiot.

Lol it’s a wonder our ancestors just didn’t smother there young , especially if they knew the holier than thou additude running rampant here… If you think the public is stupid and ignorant they your mistaken most aren’t some are but you take the cake thinking every one is stupider that you

Agreed. This will be used to argue creationism if found.

Sure we do. We love reading lame attempts like this to try and keep the antiquated “evolution” argument still alive. Lol. DNA is just too complex to just have POPPED into existence, and it sure didn’t evolve from a fish.

All I can say is that when you follow the science the science constantly changes. Therefore I’ll say is; and this too will pass. This new finite thought, believed to be the absolute all-knowing will be erased when science reveals new truths. Paridise reveals all.

It’s not only creationists but also white supremacists, who just can’t stomach the established, “out of Africa” theory, and sci-fi panspermia nutjobs.

And the Lord God formed man of the dust of the ground, and breathed into his nostrils the breath of life; and man became a living soul.

Be not deceived; God is not mocked: for whatsoever a man soweth, that shall he also reap.

That would make your God a Sorcerer too which both Never existed ?

Nice troll.

Why would the Lord be seperate from our origins, evolution and creation are the same story, how we got here.

How can we ever truly call ourselves civilized if we go on believing in spooks and fairy tales, told by farmers and also curious humans of course, thousands of years ago. It’s more than time to dish out superstition and spooks from the lives of modern society.

White… suprema…. BWAAAHAHAHAHAAAA! OMG, you lefties see the walls dripping with racism and oogly-boogly un-PC shadows XD

I feel your ignorance.

This newfound fox News technique of reverse the truth is exactly what destroyed the republican party of old and fed this new LIE in every sentence rodent masquerading as Republicans. Its not political its SCIENCE.

It’s also evident by how weak “White” genes are. A Black man with a white woman or white man with a Black woman results in Black children. That is because the original people are Black. “White” people are anomalies, they are the result of inbreeding which locked in weak recessive genes, genes that serve no benefit for humanity overall.

This guy probably still scared of Albanos. Tell me arevyou still practicing cannibalism, or has your witchdoctor told your tribe of Cargo Cult psychotics to stop that practice.

Hello. Interesting article. The comments are pretty silly. Will you please answer the question of validity to these new theories in light of the mitochondrial Eve research? We cannot invent non-existing origin, not can we invent extra time to reinforce hypothesis.

Almost black. Another white mates with the almost black & wala! White! WHO cares!! Why can’t people seek peace rather than ‘I’m better than you’ geez Oh, I’m 5th generation from a black grand dad…I’m white.

And you have the genes from the inbreeding. This is what makes whites unstable and historically attack others. The stock human is the Black man and Black woman. Just like the Steppe Wolf is the base from which the dog came from. The dog with it’s breeds are inbred and those inbred breeds have a lot of unstable characteristics. Many are nervous and shake all the time, while others bite out of the blue. The stock human is what the ancient Egyptians, Greeks, Romans, and Babylonians were, even many Chinese. You all come from the stock Black human but you all have many unstable characteristics from inbreeding during the last few thousand years.

Are you truly?……let’s see that DNA.

So, there’s been hundreds of thousands of years worth of dead people and these various types of homo erected variants, but there’s not enough evidence in the fossil records? There should be an abundance of fossil records. Just like with one type of animal turning into another type. There’s not enough fossil evidence. That’s why these things are always considered theories. It can never be a scientific fact. Science is observable, testable, and has to be repeatable. Every day we hear of some new humanoid that someone has discovered and people want to be right so badly that they will believe anything that supports what they want the evidence to say, either evolutionist or creationists that they just vomit it out of their mouths as a proven fact. I never believed in God growing up, but I never believed that we came from monkeys either or that one animal turned into another. We’ve had recorded history for thousands of years now and nobody has witnessed any transition of one animal into another. Even though people considered the “Big Bang Theory “ to be facts are now having to scramble and make excuses for why the new James Webb telescope isn’t showing expansion at a rate of the universe that is inconsistent with what it would have to be in order for the Big Bang to be true. There are many other problems that are arising with the theory as new information is coming in with the new telescope also. I could never get on board with nothing exploded into everything and order came out of chaos. Nothing just happen to put itself together in nature. We see that nature is destructive. It also violates the 2nd law of thermodynamics. I mean just logically speaking it is more likely that a being put this together than nothing exploded into everything that makes up the universe, that everything that just happens to be needed to sustain life overcame odds and also came from nothing, then chemicals just happened to come together to become a single cell organism that actually survived and produced offspring and this either happened multiple times for the different species or we all came from this miraculous single cell asexual organism that miraculously knew it had to find nurishment and to replicate without having a brain. Then after those miraculous events the offspring had to know the same things, plus add new things to start becoming a complex organism. These things had to each want to evolve into the same exact thing to keep trying through trial and error until they made it. Call me what you will, but after years of thinking it completely through, I’m going with a creator and I’m happy about that because I know what I believe and where I’m going when I die. I also know my life is worth something and that I’m not one of these people that believes life is a cosmic accident and there’s no real purpose to life. Then they fear death believing it’s the end, but they aren’t really certain because they could be wrong and what if they are? Most popular atheists were contemplating this on their deathbeds and terrified of both prospects really, but at least if they were right the would be in hell for all eternity just because they didn’t want to believe in Jesus as the Christ, the Son of God that came into this world to die for the sins of mankind, was buried, and rose again defeating death for them. People get stuck on Jesus rising from the grace. There were over 300 witnesses. It doesn’t take that many witnesses to prove your case, but many atheist’s have tried to prove this false and end up becoming believers. You should try it. If the resurrection of Jesus never happened then Christianity can be proven false. There will be some religious nutcracker that reads this and will say it takes more than just believing, but I know the Bible. They will use James 2 “faith without works is dead” to try to prove their point. I agree that that faith is dead. It’s not doing anything for anyone, yet it’s still faith and all it takes is a moment of faith to be saved. The way you live after that is supposed to be between you and the Lord. I know once I believed and understood what I was given then I wanted to get to know this God. I wanted to please Him because I was grateful. I struggle to stay grateful. My sinful nature gets the best of me and I go my own way at times, but He always leads me back to Himself and I learn more on how to overcome those things. God never expected anyone to be perfect. Before or after receiving salvation. That’s why He had to send His only Son. If you live for Him you will find peace of mind in this life and if you are His son or daughter and don’t choose to live for Him then He chastises you as a parent would their child. If you continue you could be called home early and not fulfill a purpose He has for your life and lose a reward you may have gotten, but He will never let you go, He will never lose you. It took me years of really thinking this through because I wanted to do what I wanted to do and I didn’t want to have to answer to anyone. I understand that mentality, but don’t let it be too late that you come to understand that God made salvation so easy because He loves the whole human race, but satan has distorted His message and used self righteous and religious people to turn His message of love and a free gift to one of making humans believe they are unworthy and that they must first become righteous before they can be saved which is a works bard salvation and the Bible says that salvation must be accepted as a free gift. Anyone that tries to come another way is a thief and a liar. These people try to steal God’s glory and He won’t have that.

You’re a sick person.infact the only racism i see is from lefties or as i call them illiterates.

If we’re heading towards another mass extinction because of man, greed, ignorance and not being able to remove one’s head from their bottom, long enough to look around at the poison Mother Earth has endured. Possibly realize we’re all connected and interconnected. The children of the world don’t deserve to grow up in this. It’s supposed to get worse before it get’s better. The old ways of corruption and greed do not work. Has the pandemic not taught the ignorant anything? There’s definitely a difference between knowledge and wisdom. If you had either you’d know we’re all connected. Why so much hate in your heart… Did you not design the blueprint of your human experience on this Earth plane? Or did you forget.. the veil of forgetfulness. What’s hu? What’s man? Darker hues act as a natural sunblock. Maybe bill Nye can explain. The Bible is also man made. The creator is in everything. Love. Love. Love. Love. Love. Love. Love. Love. Love. Love. Love.

History past and present shows who on the planet surface has promulgated a cultural sick psychosis of hatred.

And yet inbreeding is common where? https://worldpopulationreview.com/country-rankings/inbreeding-by-country

Inbreeding had to start somewhere for there to even be a population to migrate. The recessive and ‘weak’ genes were developed before they showed themselves. The northern migration caused genetic mutation due to less sunlight such as a lower level of melatin in the skin, redheads being able to produce their own Vitamin D due to lack of sunlight and so forth. Survival of the fittest is an instinct of any species. Even female bees kill off the male bees in the cooler months when food reserves dwindle due to lack of available pollen. So,I fail to get your point of why white are unstable and attack others. Your posts sound exactly like the mantra of the UBN gang, United Blood Nation.

Love it Pam!!

You sound like quite the racist. Be better.

That is so untrue. There are many biracial children of black/white parents that look totally Caucasian! The singer Halsey is a great example, white mom, black dad.

Being educated doesn’t necessarily involve knowing/understanding evolutionary &-or genetics’ nomenclature & theories, i,e., ignorance of the latter =/= being a part of the “uneducated public.”

Amen just because you went to college doesn’t mean you are the base color from which everyone evolved from, oh yeah black gene is the strong gene, it is the base color, if that were true everyone would be getting darker not lighter,ignorance multiplied by ignorance is the amount of people that graduate college.schools largely teach what ignorant people that believe in the bible want the schools to teach,mainly because if there wasn’t a Bible or something ignorant to occupy our time, we might actually figure out way off this prison planet and how to get our powers back.

What? That makes zero sense. Fox News university must’ve taught you that because it literally is some kind of psuedo science.

Wot a wicked awesome answer! Way 2go! Brilliant. Love it!

Being educated doesn’t necessarily involve knowing/understanding evolutionary &-or genetics’ nomenclature & theories, i.e., ignorance of the latter =/= being a part of the “uneducated public.”

True.i know many highly educated idiots

Thank you. My thoughts exactly.

Exactly what does the educated public believe? Because as I’ve seen over the past few years, the fossil record seems to have been inaccurate up till very recently.

We get theoretical scientific opinion which is not even best guess scenario to try and pound a square peg into a round hole! The probabilities of this mass evolution, is an epic impossibility.

Where is all of the evidence of these so-called links which seem to be missing. More best guess scenario? Throughout the ancient or semi-anient written history, where are descriptions of those links? I haven’t seen any! From 1 single-celled organism, everything on this planet has arisen. Seems pretty far-fetched! Considering what it would take to just randomly apply the right amount of chemicals to create a living organism, which humanity has been trying for over 100 years!

Now all of a sudden all these different life forms evolved around the same time? What’s the probability of that? Just the thought process behind it is extremely unintellectual.

Just like going from asexual procreation to sexual procreation meiosis versus mitosis, The much easier, division of one cell into two cells. They both are identical! And somehow that changed into two cells combining their DNA to form a separate and distinct offspring! Something so much more complicated, even more so than night and day, proves ignorance and a heaping helping of naivety.

How many aminos are there? 26? How complicated was just one amino acid to accidentally occur? Now, assuming all 26 evolved out of thin air, how many aminos does it take to make a protein? And how come all of these random applications of amino acids make thousands of different proteins? Many of these proteins in one cell?

And let’s take a look at how these proteins are arranged to form DNA, and then, let’s not forget RNA, which is necessary to be able to read the DNA. It just becomes more and more complicated! So, who’s uneducated?

You’ve got people on these threads freaking out about artificial intelligence, and it turning on humanity, but then humanity was not a product of intelligent design? You all just contradict yourselves!

Well said as a round peg fitting the round hole, My hat’s off to you

I completely agree. It’s like they write these kind of articles or “find” these “New” findings to make themselves feel productive or as if they are doing something, anything!… they want proof for their boredom because honestly they aren’t proving anything new to the human race in this day in age especially when you can’t even understand what they are saying. They really should study up on media, networking, social skills , grammar. I’m just saying. Something else so much more of importance could have taken space here . Rather than this article that not only repeats what we have known, but explains it in a way that we don’t when care to know. Oooooo ahhhhhh woooooowwww how fascinating.

Interbreeding ,and creationlists . My oh my. What do you believe. If so monkeys evolves into ,homosapians, is it? They all would have .So that theroey is out the window. Jesus alpha is now %100pure water. He and only he is %100 . And does exist even if science can’t find it. It is right infront there eyes yet they denied him. I do like bananas. Have a nice day.

What about my updated my history story

I read all of your comments . And do not a single one of you know that our existence was by design to do the work of a superior race that where here to mine the planet resources. Tens of thousands stone tables explaine this . Why would anyone take the time to write in stone what and where we came if “that what is written isn’t true. Origin has already be explained except it and move on…

Scitechdaily has plenty of crazy religious people and general nutjobs. Every time they cover quantum anything people come out to say how stupid or amazing or useless or a bunch of other superlatives it is.

135,000 years for the African populations doesn’t explain 300,000 year old foot prints found in Germany recently. “Out of Africa” and “palace/temple” fetishes of Science and Archaeologist never ceases to amaze/humor me. Perhaps one day we’ll come to the truth, but not “everyone accepts Africa” or Science’s blockage of fresh non narrative finds.

Surprise! Neanderthals had feet and are not Homo sapiens

How much DNA can you get out of a footprint?

For all we know our existance was via a primer designed by a species that has been around since the big bang. An extra-terrestrial species that planted our DNA 300 millions years ago in the sea during Pangea

there it is

You don’t mean God, do you?

Creationist here. But I am not your typical type – I do believe that Evolution is the process that was the original intent of God assuming that He did not foresee the coming disobedience (not likely). So nothing here challenges a God creator – it only affirms it in my view. How? Simply, Evolution is a perfecting process – and God is perfect. There is no conflict nor contradiction. I am happy to illuminate further according to your valued questions.

Never use the Word of God wrongly or become an accuser of the saints as this makes you a devil.

Personally, I’m a “Crevolutionist” – Intelligent design and then hands-off since the Big Bang.

But then the Biblical narrative breaks. I see in Genesis 1 an initial creation with evolution set in motion and hands off UNTIL the revolt of angels led by Lucifer which caused a great disruption in the universe – particularly centered on God’s little “project”. Then God re-formed everything and just finished man.

Except your interpretation isn’t in alignment with texts older than the Bible… like the Gita. Crevolution isn’t disharmonious with any Talmund, the Gita, Gautama’s writings or the Bible. Look for the common thread and run with it.

We’re just as likely an experiment if that’s the case. Our entire universe could conceivably exist on someone’s lab table. Given the dilatant nature of time, it could be argued that the entirety of our planetary and celestial experience could have occured in mere seconds from the perspective of an outside observer.

The Bible is not a Harry Potter novel written by a monk. Those who do not believe should read the prophet Isaiah. “On this mountain HE will destroy the WEB THAT IS WOVEN OVER ALL NATIONS.” The world wide web is here. The end is coming near.

Your premises – inherently flawed, & therefore such inferences that are based on them – fallacious. For knowledge of our origin, noology is the way.

Your premises – inherently flawed, & therefore such inferences that are based on them – fallacious. For the knowledge of our origin, noology is the way.

This discovery is explaining evolution but does not explain the origin of man. Its just a rubber stamp to adaptation of man to its environment over time.

Sometimes when one group fears even the ideas presented by another group, they shoot out insults like “nutcases and nutjobs.” I certainly am convinced that not only human beings, but also all other physical things were created by Jesus the Christ. When He returned to His own created earth about 2,000 years ago, many of them did the same thing some of you are doing right, which is reject Him and sling nasty insults at those who acknowledge Him as the creator of all things. All of these “theories” of human evolution refuse to deal with the most crucial issue of “origins.” You cannot have gradual change of something that does not exist to begin with. Forget this game of theories called “human evolution.” Force yourself to actually deal with the issue of “origins.” Your scientist “god” with all his fancy letters before or after his name will never be able to deliver you that reality, no matter how much faith you invest in him. The truth is that ever since sin entered the human heart, human beings have been coming up with every imaginable means to deny the God Who made them, so that they can try to deny the judgment that will come as a consequence of their sins. Put your faith in Jesus the Christ, the Great Savior, not the scientist who has no power to save.

Scientists have saved a great many live in history so I think that shoots your comment dead pretty quickly. Also it sounds reasonable that science is the mechanics of how God made the universe work and set the marble in motion to then step back and see what happens. God is a scientist, and is simply taking notes on what happened after after this universe of an engine was created. To put more stock into why God did anything is to simply waste your time. We can figure out how but why really doesn’t matter. Once you die you die and you’ll find out. We just pull each other down trying to find out while we are alive.. if you really want to know then just kill yourself…

It shoots nothing dead actually. I was not referring to just the physical “life” our bodies experience here on earth. According to Jesus the Christ, your condition in the next life that comes are this present one ends is exceeding more important, so much so that gaining all the material wealth, health, and comforts possible in this life, cannot even begin to compare to the value of the next, provided you have be saved from the consequence of your sins. Jesus was more than qualified to speak about such a topic in that He actually died and ressurect from the dead about 3 days later, by the way. Research it. It’s an undeniable historical fact of which I recommend the work of the distinguished scholar, Dr. Garry Habermas.

You speak of “science” like many others do, as if it is actually tool entity capable of enacting or doing something. Let me explain something to you, “science” is a powerless, non-entity. It can do nothing. Here is an Oxford dictionary definition of science: “The systematic study of structure and behavior of the physical and natural world through observation, experimentation, and the testing of theories against the evidence obtained.” So, by definition, a omnipotent and oniscient Creator God, does not need to use “science” to do anything. He created the very physical laws and principles that these “scientists” simply “monkey” (sorry, hard to avoid the pun here) around and eventualy discover by deduction that they exist.

You speak very confidently about what God did and why (i.e. – God is a scientist and is simply passively sitting back watching things unfold and taking notes on them.) Where did you get this information from?? Because, in the bible, where we find the only recorded history/source of God’s revelation to humanity, He states things like this: “Remember this and show yourselves men; Recall to mind, O you unrighteous. Remember the former things of old, for I am God, and there is no other; I am God, and there is none like Me, declaring the end from the beginning, and from ancient times things that are not yet done, saying, ‘My counsel shall stand, and I will do all My pleasure, calling a bird of prey from the east, the man who executes My counsel, from a far country. Indeed I have spoken it; I will also bring it to pass. I have purposed it; I will also do it.”

Does that honestly sound like a God passively observing the history of the world unfold while He takes notes? I could provide probably hundreds of such clear declarations from God in His word unequivocally stating that He is determines and actively fulfills the events in His creation. He is sovereign over all things. When I hear people make these statements about God passively observing world history, I have to thing they are either just ignorant of the Bible or just flat out deceptive. Many of these people are the same ones quick to ask where was God when 911 or some “natural” calamity happened.

As far as your statement about it being futile to try and answer the questions of WHY God does things, I’m not really sure what triggered that, but that is a pretty authoritative statement on your part that I would certainly dissagree with. Firstly, trying to understand the matter of “origins” as opposed to leap-frogging to focus solely on the issue of “transitions/change/evolution” is not a WHY question, it is still a HOW question. I think you are confusing categories there.

However, it is NOT a waste of time to try to figure out WHY we exist, because the why helps to answer the question of purpose, which is often tied to where we are going (destination). The “why” really does matter, because it is actually what helps to prevent this futility you hinted to. This same Jesus the Christ, Creator of the universe, said our purpose is to be in a right relationship and interaction with Him our Creator. However, this can only come about by us trusting in Him and his substitutionay death in payment for our sins/moral crimes against Him. I don’t need to die to learn about what happens in the life to come. Christ Jesus has already made that plain and His word is truth. I have no desire whatsoever to kill myself. I often wonder how those who actually believe this utter non-sense which produce a purely futile existence manage to not just kill themselves. But then again, per the current statistics, sadly many of them do including the young who are being fed this empty worldview in thier public school systems.

So many lies from so many previously legit sources means nothing can necessarily be believed. Sad state of affairs. Lefties have poisoned the well of knowledge.

I would challenge anyone who feels there is no creator, to name one single thing in existence today which just suddenly appeared magically, mysteriously. How about your dating process? Which of your tools u use to make these outrageous determinations evolved as described by Darwin? Further , in the thousands of years of written history, is there one single instance of a documented evolutionary new species evolving from one already in existence ? Without any intervention or manipulation from an outside source ? Better yet let’s use the scientific process and let’s take let’s say a Rolex watch probably the finest timepiece ever invented by man’s efforts and let’s disassemble it and put all of its parts in a bowl. now will that watch ever become a working Rolex again? Even if you were to toss the parts in the air and catch them in the bowl again I don’t care how many times you do it it will never become a working watch. It’s a theory and remember it is a theory of evolution was true then certainly after a billion or so tosses in the air that watch would reassemble itself and work again. Now tell me who’s the fool the one who believes that he was created by design from a higher power or the one who believes he just occurred accidentally through the process of mutations. If the process of being we’re such as a scientist state then certainly they would be able to recreate that process . can you give me one example where they have? I challenge anyone who believes they are here simply by accident due to mutations to go ask your mother how you came to be . Tell her you were an accident and a mutation . I mean if mutations in theory of evolution were true then how come we don’t have new humanoid species popping up all over the place ? I mean if it worked then wouldn’t it still work now? If this all occurred over hundreds of millions of years and mankind was the end result why hasn’t it taken it any further after all according to you it’s had hundreds of millions of years to evolve don’t you think that during that time. Something new would have come about? I’m sorry for you that you feel you’re so worthless that you were just nothing but an accident. I’m sorry for you that you don’t see enough value in yourself to believe that someone took the time to design and make you.And I am sorry for you that you don’t have enough intellectual capability to look around you at the things that exist not that man has made but that was purported to have been created or evolved as you put it and not see the intricacy the complications the beauty and the wondrous nature of all that exists. I would challenge any of you who say there is no God of creation to produce something nearly as wondrous as you reside in but to do it as you stated it happened through accidental mutation. There’s nothing accidental about the human body and the wondrous nature of its workings. There is nothing accidental about the organism you call home known as planet Earth. Please by all means step up and create for me a universe filled with stars and planets . And in your process of judging what tools that were supernatural did you use to make these measurements? Because if you were using tools manufactured by man, then you were using a tool with limited understanding. Those of you who seek the truth but do so using information that is untrue our only fools of your own demise. I’m sorry that you have no respect for the creation that was given such to the point that you are destroying your own host namely planet Earth. Your lack of respect for all that was created will be your own undoing. And I am sorry for you that your existence will cease to be by your own hands. Let me ask you a question scoffers. It’s a theory of evolution were true then that would have to hold true for all things including the progression of knowledge. so am I to believe that the processes as you describe them to have occurred or what make the very things you discovering exist or did they exist before you came to these conclusions? Whom among you has lived long enough to actually test the theory of evolution? Those of you lacking knowledge know this the very first act of God was to separate the darkness from the light. To those of you who dwell in darkness cry cry for the dying of the darkness, for the light of the world cometh and before him every knee shall bow. Soon yes very soon you will know be on the shadow of a doubt what is true and what is right. I pray you do not pass before this occurs so that you may truly know your maker.

I’m a new firm believer and decided to become a student of the Hermetic philosophy and the three initiates of the Quabalian… I hope I quoted that right.. lol, but I am or we, individually yet connected, what ‘ALL’ is or has me created to be. From what I’ve studied, Most is true to how you express your belief, but with more than enough acknowledgents of angels & demons, higher spirits, even God, Jesus, and Lucifer. Sure! We as individuals get our rights and choices of in whatever and/or whomever they feel is their proper. In the end, we are only an energy embodied into earth as a living organism created by the “ALL” itself. THAT IS ALL AND NITHING IS GREATER THAN THE ALL. THE ALL even created EVERYTHING we humans want to or shall want to believe in. Heaven n Hell though, is in us just as GOD is in us altogether. But in us, we are creators of ALL that we see! An imagery of we visioned simply from our mind, reenacting and believing it to be real and so, making and becoming a reality A PERSON(S) dream became a reality. An imagery once upon a time, a crazy, out of this World thought! This, I do strongly believe in. And to answer both of your questions.. Sure, I have faith there was a GOD and what not, I never got PAST page 4 in any bible CAUSE so merging inside my beliefs and true faith is not found in such writings passed down and rewrote for society to be controlled, thanks but no thanks, and my apologies if you feel opposed, that is honorably your mind to do so. I got my true belief and My own faith, but you got yours so I won’t bother expressing n save myself my passion of… And YES, with the right mind and dedication, ANYONE could fix that ROLEX watch after being dismantled, 1.) But why would I, I can just send it in via mail to either have it resolved or fixed. 2. It would be of course challenging, but If I were to, I WOULD “believe” i could fix and have “Faith” I should have the ability in, MYSELF, that I can… For All the power in me, I will have got it. You see.. To think it’s “impossible” is allowing yourself to believe it can’t be done by ANYONE. ME PERSONALLY, “I’M POSSIBLE” I always believe I can and have faith in myself as well it can be done.. Fine! If not by me, it shall be concurred for my faith I create for such person! THANKS FOR you disregard of faith in others, but such is Life. SORRY NOT SORRY, But we as one, ARE IN THIS TOGETHER. I too, love thy neighbor! As I respect you, always! Cheers! Poor ROLEX. LOL 😉 Sincerely, J.G.C. (CANADA)

And to those of you wondering what about the Rolex let me just say this it took a master creator to make that watch in the first place and it would take a master creator to put it back together and make it work again so just like the Rolex are you to the maker if you find yourself in pieces and you want to be put back together again turn to God he created you he loves you and he can mend you.

@MOCTrust – I dont really know how to even begin to put into words the affect your “Rolex / master creator” explanation comment has had on me.

It is beautiful and I must thank you.

So I’m from London UK and used to debating and critical thinking on most subjects and thought this was an educational site but I find the actual pieces rather disjointed to say the least but the comments after I find just a slanging match, never mind where we came from but where are to heading to because this isn’t ok.

The Lord made a quantum universe, from pop ups on the screen to the farthest stars and galaxies being in my quantum opinion magnified veiws of sub-atomic particles.

I think the most relevant thing here is that YOU ARE. now what are u going to do with it?

Hey folks we live in a universe where everything we think we know is wrong or at best incomplete every time we come up to a solution to a problem only leads to more questions that in itself is the exciting part of the problem

Do any of you have jobs. Please just go serve someone with your skills and leave this back and forth discussion. It serves no one. Service is God.

The universe and the natural forces that exist within it are not capable of creating themselves. Only a supernatural force can create something from nothing. We are animals evolved from apes just like all other evolved animals today. We and all other living animals await our recontinued nonexistence.

Fact: The many of stories of the old testament were not true. Noah, Moses, Adam an eve , etc did not exist. The stories of the new testament were written many years after Jesus died on the cross and contradict. None of these stories were written by the actual apostles that walked around with Jesus. That makes you really wonder why these people did not write anything if they really believed Jesus was divine including Jesus own brother. The council of nicea forced the followers at the point of a blade. Most religions are based on violence, the crusades, the Muslims holy wars , etc Homosapien apes are not the image of God.

I owe my life to GoD as I see It .

After reading through these comments it is fairly clear that regardless of where we started, we have not evolved. In fact we have simply become semi educated a – holes.

It “human race” not “species”. And I for one already know where the human race came from, God!

Grow up, whoever is on this black people white people crap have obviously forgot something explain Chinese, Mexican, Indians, Columbians, etc….. come on im waiting. It’s simple people as the continent broke apart evolution came about where that continent lie evolution took place and that’s why there are different races I hate to tell people this but seriously maybe we all were Jewish, or middle eastern. Many years ago I doubt a skin colored darker than lighter skin colors could have survived in Greenland, Finland, and I doubt that lighter skin colored people could have survived in Africa, Mexico Jamaica. It’s obvious that evolution has made people the color they are one day because the majority of us dont live outside we will all be one race. Who cares all of us every single one of us does not realize that there are major effects to our systems that happen because of what we have been thru and how we deal with it. That does not make anyone better or stronger. Im sorry that black people today feel the need to have to say stupid ridiculous s#!t that they are stronger lol. No one is. My kids are mixed my sisters kids are mixed my daughter white blue yes, light hair my son having the same father is a mix in color, and neither one is better than the other and if you want the truth my son has more medical problems than my white mixed daughter. So that is bullcrap. Also medical speaking black people above all other races alhave more medical problems than anyone and are susceptible to diseases that only black people can get. That right there tells me your no better than I am nor am I better than you. Grow the hell up, this talk is racissist and yes you are a racissist black person. Who obviously feels intimidated by white people. And don’t tell me cuz you were a slave. Your ancestors were the ones who sold you to be slaves. Direct your anger towards that. Of course if your ancestors were never sold you more than likely would be in a village in Africa right now having no access to these forums not to mention knowing how to read and write. Sorry if my spelling is incorrect im on my phone and it’s about to die so I can’t go back and proof read. God bless stop the hate things are evolved quit this bulls*** this is what is ruining this country this world and your letting the evil government influence your judgment. In order for there to be peace we need to come together. They don’t want that their mission is to divide and conquer. Grow up seriously its old its annoying and everyone is sick of your crying about being oppressed its insane I wish I had scholarships to go to school cuz im white!! I wish that I could apply for grants cuz im white Grow up. No one not one race has suffered as much as the jews and you never hear them cry, you never hear them complain or blame there faults on anyone but themselves.

Wait I have 3% left battery, so ladies do you know what our government wants to call us now, mind you men are men or man, but w9men are being called “birthing units” now what in all honesty women are the ones who suffer because of men. This is insane look it up I promise you that is how we are viewed.

First off, they really need to pull their heads out of their a**** and start dealing with the fact that not all people originated from Africa. And 95% of humans alive today have Neanderthal in their DNA. Neanderthals did not originate in Africa. Second, I’d like to address this subject of a singular god creating all things. Stop and think about the fact that, before christianity, cultures from all over the world, who never interacted with each other or knew other cultures existed, at one time had many gods; sun gods, moon gods, thunder, lightning, rain, plants, light, death, etc…and strangely, alot of those cultures had the same number of gods. As populations grew and cultures advanced, they started learning of each other. Then along comes a zealot who wants power and control and for everyone to worship him or follow his beliefs. With this comes the problem of convincing people. So this zealot and his followers devise a plan on how to do so. They take bits and pieces of all these different cultures and make them part of their religion and center them around their main character, if you will, and they write a fantastic story, and sagas were part of every culture, the better the story, the more it would be repeated. Best example; the wafer and wine was stolen from the druids. And slowly people started following the zealot and those people convinced others to follow. And as we all know fanatics will do anything to accomplish their goal. Imprisonment, beatings, public displays, even murder. Spanish inquisition comes to mind. Christians have managed to force their beliefs on many cultures because they deemed them as savages and their selves as superior. We all are parts of the so called human race, no matter our color, beliefs, or education. All are equal and none should be on a pedestal of their own making.

Can’t wait to get back to where we don’t see colors or hate anymore peace and amen back to the beauty and love sharing

When we all go “home”. our true essence is formless.

The FACT that Darwin’s THEORY of Evolution IS NOT NAMED Darwin’s LAW of Evolution, tells it all.

I will never be able to believe people turned white lol, when literally melanin is cause over time from the sun. Believe what you want but there is a common theme around the last 30 years or more with information. My roots do not come from africa I assure you neither does the earliest pieces of art, architecture, and ideas from humans africa was late and still is sticks and stones in alot of areas… another way to bend and warp minds into thinking we are one with the masses of immigrants same as social medias selective cancel feature the list goes on. Can’t be mad at the white man for being the alpha.

We are evolution

I bought a Lada in 1804 and buried it in the Sahara Desert. In 2023 I exhumed a beautiful BMW. True science is worth a lot. The aforementioned is only reading material.

Meaning no monkey involved…

Yeap… we all came from Mars. Then we started breeding with the natives.

Genesis 1:27 So God created man in his own image, in the image of God created he him; male and female created he them.

Believe in Jesus Christ and be saved.

Thank you Holy spirit for opening my eyes,thank you Jesus for paying my debts, Thank you Father for saving me .Now I Can See how great thy salvation is.I was deceived,I was in darkness, I was Doomed,but now I have everlasting life.

For us Oh God for falsely information like this, l believe your word from Genesis to Revelation, This is against your Word, only you can change the mind of your human creation 🙏🏽So sad 😢, l see what we can’t believe everything we see or hear 🙏🏽♥️🙏🏽

Lol good one!

I am a deacon in the lutheran church my question to evolutionist how do you prove your postion Since one evolution is a theory not factional two your theory has many what ifs and missing facts To prove it to be a truth the whole theory relies on Radom chance Like you say it was chance the earth is put in a orbit not too close and not to far from the sun So life can be sustainably on earth you claim man came from a slimy creature that crawled Out of the swamp and lived on land and evolved from a reptile like creature to ape then man But you can not explain why man have in only a few thousand years breed and keep dogs And we have thousands of different breeds of dogs faster then what you say through evolution Stamanites crystal found growing down from caves you claim are millions of years old But in a scientific study scientist were able to reproduce the same results. Using the same conditions in. Only a few years and you believe it took millions of years You also will not believe what the Bible talks about man and Dinosaurs both co existing at the same time On the earth we will agree with that but that was about 10 thousand years ago not millions of year ago How do you explain that

The main problem with the scientific community is the delusion to equate theory as fact. Hundreds of anthropological studies and finds have proven that the theory of evolution is not a viable explanation for the origin of species, and yet, even with so much fossils found that refutes the standard accepted theory of darwinism, the established body of scientists still cling to this weakly positioned theory. What is unknown to many in the scientific community is the reality of many fossil findings that refute the theory of evolution. To this day, it remains a theory and not a fact. There is no strong evidence of the fact that we evolved from apes. The missing link still has not been found. There are a lot of positioned speculations posing as facts when in fact anthropologists still cannot prove it and people still believe this as the most plausible theory despute a lack of evidence. Based on vedic anthropological studies, one of the reasons as to why there is a slim probability of finding any fossil remains of homosapiens is due to the ancient cultural practices that was practiced (cremation of the dead) and only the entombment of important religious and royal individuals. And second is the fact the the earth’s crust has thus been moving, along with which any such fossil remains have been moved further down the strata that anthropologists are digging down. And finally, there are hundreds of fossil finds that defy the prevailing theory on the origin of species that defy the time line and theory of darwisnism that has been systematically been kept, covered-up or dismissed just because it does not support the prevailing theory. This selective process, which goes against the scientific process of investigation, is a political movement that supresses such information because it destroys the very bedrock on which the established theory of evolution reats upon. So, anything that weakens or gives rise to proof that darwisnism is wrong is systematically erased to ensure darwisnism continues to gain acceptance in the scientific community. You may read the book forbidden archaelogy which exposes and details the analysis and findings including the systemic eradication of all finds and proof that challenges the established theory of evolution as the origin of species. There you will find more proof that humans (modern and ancient) have existed longer than what evolutionists believe to be true. Evolutionists are so afraid of these finds and systemically eradicate or cover them up, in fear of weakening their claims to the origin of species that creationists may piggy back on. I am not saying creationists are necessaraily correct, but factually what the reality is, the theory of evolution is definitely not the factual explanation of our origin.

Babel again.

The lie is in the words “closely related species”. Wonder why the species were closely related? Some people still pay attention to detail.

I think if God doesn’t step in man with all his knowledge will end up destroying himself!

There is no God, never been. Learn history of your religions, Christianity is also a copy… it’s all so obvious, how can people be so stupid to believe in a book of ancients fairytales is beyond me.

Yeah I’m not an African monkey, sorry.

Scripture is correct it is not always literal and makes use of metaphor. For example the Genesis 1 narrative is related to chaos theory and emergence. Day 1 being the creation of the fundamental constants such as glthe light constant C. Day two is the seperation of structures of the cosmos from the voids. 6000 years is the age of human civilization. With the start if the 7th milleniun being the end. The return of Christ will bring about the eternal sabath.

Proof of the spiritual can be seen that we have found no intelligent life even though we looked and our existence proves it is possible. There js even a seal in the sky which shows we are at the exact place abd time; there is no scientific reason that the sun and moon are exactly the same size in the sky so we can have perfect solar eclipses.

The garden of Eden is the Earth by the way. Man being placed in it indicates perfect harmony with God and nature with the four rivers surrounding it being the four fundamental forces of the universe. Mam being expelled fromntge garden represents him being out of sync with nature since disobeying God.

To me (opinion) a large number these “opinions “ show a complete disregard for humanity. It appears that it’s easier to hate and give in to easy line of reasoning created by hate. There are so many big lies to go around and of course it’s what someone believes to be true, not to be confused with faith, because in today’s world a lie is easier to believe (what’s in your heart?) than a truth. A big lie comes from hate. When hate is in your heart there is a focus in one direction and anything else is a lie.

There will never be any scientific proof to replace God, as long as these non-believers keep trying to push God out of any existence, Faith will always overcome the lies. but that’s what people forget He have us a choice the easy road or wide road which leads to destruction or the narrow road and hard tough road which leads to Appreciation, Respect, Accountability and Life. As Jesus said I am the way and the only way to the Father. God Bless. Remember to love one another.

Man spread out far and wide since the dawn of time. It’s funny to me, how they are testing a small tribe in one area and basing their findings off that alone. You would need to test the whole area and then cross reference against other areas, to only see, that there were many migrations “out of Africa.” I’ve recorded my DNA matches for 8 years now and I do see from my “time invested,” that we didn’t intermix with other areas, like stated. May be the “common folks did,” but the ones “in power,” did NOT! The only time the intermixing of bloodlines happened were for power, doweries, land, and bring peace to an area. The main recorded “Historical Figures,” intermarried, until something (to enhance their power) came alone. I know this for a fact, and until others take the time with their DNA Matches like I did (and still do) you will NOT know the truth about your family’s origins. All the platforms that offer DNA testing, don’t tell “the masses” this little fact, thousands of hours of one’s life is needed to find out one’s true origins. DNA is a puzzle, 1 DNA match is a puzzle piece and time is needed to build the big “puzzle picture” of one’s origins; that don’t come from a swab, it comes from time invested! No one seems to have the time needed, so it will always come full circle to “the masses,” learning from particle research, and what they want you to believe;) Do the work and don’t listen to sites like this. The only reason I came across this article, I asked google, “Why do DNA platforms lie about origins?” After years of recording, my origin narrowed drastically and now I know my family’s true story. The original origins and what I have today is VERY different! Most of the testers will NOT know their truth, it takes work. Just thought I’d share this FACT if any of you are testing to find out your family’s origins.

***Correction*** The only time the external mixing of bloodlines happened, were for power, doweries, land, and bring peace to an area.

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NSF awards $275K grant to Amplified Sciences to develop new platform of ultrasensitive clinical diagnostics

Amplified Sciences, a clinical-stage life sciences diagnostic company, has received a $275,000 Small Business Innovation Research grant from the National Science Foundation. The funding will support critical development of the company’s tests for early, more accurate detection of challenging diseases, starting with pancreatic cancer. (Purdue Research Foundation photo/Vincent Walter)

State has awarded $50K matching grant through the Indiana Economic Development Corp.’s Applied Research Institute

WEST LAFAYETTE, Ind. — The National Science Foundation has awarded a $275,000 Phase 1 Small Business Innovation Research (SBIR) grant to Amplified Sciences . The clinical-stage life sciences diagnostic company is developing tests for early, more accurate detection of challenging diseases, starting with pancreatic cancer.

Amplified Sciences has received a Phase I matching grant of $50,000 from the Indiana Economic Development Corp.’s Applied Research Institute.

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“This, our second SBIR award, will enable further development of multiplexing capabilities for pancreatic cancer panels and beyond,” Caldwell said. “We are excited to be awarded this highly competitive NSF SBIR grant. This brings our total of nondilutive funding to over $1 million.”

Amplified Sciences also recently received investments worth $108,000 from the Flywheel Fund . In 2023 the company received a Phase 1 SBIR grant of approximately $400,000 from the National Cancer Institute and a $50,000 match from the state of Indiana to develop pancreatic cancer risk stratification tests. It was named to the Pepperdine University Graziadio Business School’s Most Fundable Companies list in 2021 and to the New York University Stern School of Business’ Endless Frontier Labs life science cohort in 2022.

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In its Cancer Facts & Figures 2023 report , the American Cancer Society estimated that more than 64,000 Americans were expected to be diagnosed with new cases of pancreatic cancer in 2023. It estimated that more than 50,000 would die from the disease in 2023.

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Population monitoring of trisomy 21: problems and approaches

• Karl Sperling   ORCID: orcid.org/0000-0003-2305-4370 1 ,
• Hagen Scherb 2 &
• Heidemarie Neitzel 1  

Molecular Cytogenetics volume  16 , Article number:  6 ( 2023 ) Cite this article

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Trisomy 21 (Down syndrome) is the most common autosomal aneuploidy among newborns. About 90% result from meiotic nondisjunction during oogenesis, which occurs around conception, when also the most profound epigenetic modifications take place. Thus, maternal meiosis is an error prone process with an extreme sensitivity to endogenous factors, as exemplified by maternal age. This contrasts with the missing acceptance of causal exogenous factors. The proof of an environmental agent is a great challenge, both with respect to ascertainment bias, determination of time and dosage of exposure, as well as registration of the relevant individual health data affecting the birth prevalence. Based on a few exemplary epidemiological studies the feasibility of trisomy 21 monitoring is illustrated. In the nearer future the methodical premises will be clearly improved, both due to the establishment of electronic health registers and to the introduction of non-invasive prenatal tests. Down syndrome is a sentinel phenotype, presumably also with regard to other congenital anomalies. Thus, monitoring of trisomy 21 offers new chances for risk avoidance and preventive measures, but also for basic research concerning identification of relevant genomic variants involved in chromosomal nondisjunction.

Trisomy 21 (Down syndrome, DS) is the most common autosomal aneuploidy, even the most common genetic disorder among newborns. It is a sentinel phenotype, which can be easily recognized and cytogenetically verified. Trisomy 21 is registered in nearly all monitoring programs for congenital malformations as a paradigm for aneuploid mutations, e.g. in the European Surveillance of Congenital Anomalies (EUROCAT), a network of about 40 population-based registries, established in 1979 [ 1 ].

About 90% of trisomy 21 cases are due to maternal meiotic nondisjunction, whereby about 70% originate during the first meiotic division [M I] and about 20% during the second meiotic division (M II). A defective paternal meiosis is found for up to 8% of all cases. The risk of a DS birth increases over 40-fold between the ages of 20 and 45 in the absence of prenatal diagnosis and subsequent termination of pregnancy [ 2 , 3 , 4 , 5 ]. Thus, maternal age has the strongest effect on the rate of nondisjunction. An oocyte, which is ovulated by a 40-year-old woman, was arrested for about 40 years at the dictyotene stage of prophase I. During this long-time epigenetic modifications, resulting from a variety of environmental stressors, might affect MI nondisjunction, making their detection so elusive [ 6 ]. Sperm penetration of the oocyte is the trigger for MII. Consequently, the first and second meiotic divisions take place around conception (Fig.  1 ). Based on the molecular and temporal differences between maternal MI and MII it is assumed that also the risk factors for MI and MII nondisjunction errors are different [ 7 , 8 ]. Nonetheless, maternal age is a dominant risk factor for both MI and MII nondisjunction [ 9 ]. However, the incidence of MI errors is high in the youngest mothers, lowest in the intermediate age group and increasing with advanced maternal age [ 10 ]. Moreover, the meiotic recombination patterns differ between both error types [ 8 ] and this is paralleled by variants in candidate genes coding for components of the synaptonemal complex [ 5 ]. Low socioeconomic status (SES) significantly increases the risk for DS and maternal MII nondisjunction [ 11 , 12 , 13 ]. Perhaps the lifetime exposures associated with low SES may generate some adverse effect at the time of oocyte maturation. In addition, smokeless chewing tobacco was associated with a higher risk for MII nondisjunction [ 14 ].

Human meiosis and rate of aneuploidies until birth

According to Coppedè [ 15 ] “the formation, development and survival up to birth of an individual with trisomy 21 should be viewed as a complex event involving environmentally induced epigenetic modifications, genetic factors, gene–environment and gene–nutrient interactions, and selection processes spanning over at least three different generations: the maternal grandmother, the mother and the developing trisomic individual”. In the present context it is important to note that numerous studies suggested that the DS risk is increased by environmental factors, but only few studies exist where the exposure is restricted to the time around conception, such as the exposure to short-lived radionuclides from the nuclear accident at Chernobyl or the exposure to the insecticide trichlorphon (see below). However, it is realistic to assume that environmental factors at the time of conception influence both MI and MII errors, but the latter to a relatively greater extent.

Given the molecular-cytogenetic differences and temporal separation between maternal MI and MII, it is not surprising that associated risk factors differ for MI and MII nondisjunction errors [ 7 , 8 ]. Trisomy 21 is one of the few aneuploid conditions that survives to term, nonetheless about 50–80% conceptions are estimated to be lost during pregnancy [ 8 ]. Thus, about 90% of trisomy 21 cases occur around conception, when also the most profound epigenetic modifications take place [ 16 , 17 , 18 , 19 ]. Interestingly, most epidemiological studies report a male excess in DS, still a poorly understood phenomenon [ 20 ].

Altogether, the total aneuploidy rate in oocytes of young women is about 20–30% with an increase to more than 50% in women ≥ 40 years old [ 21 ]. Moreover, abnormal mitosis affects about 25% of the first three cleavage divisions [ 22 , 23 ]. The frequency of aneuploidies in human preimplantation embryos varies between 50 and 80%, depending primarily on maternal age [ 24 , 25 ]. Most of these embryos are lost during pregnancy. This incidence is more than an order of magnitude higher than in the mouse [ 26 ], which is one reason, why the extrapolation from mouse to man poses a fundamental problem with respect to the induction of nondisjunction.

From an evolutionary point of view, it seems a paradox that the high rate of aneuploidies in man, accompanied by reproductive failure, should represent a selective advantage. In fact, this is an adaptive mechanism to extend the interbirth interval from 9 months to 3 to 4 years, resulting in better overall survival rates. There is widespread agreement that humans are exceptional, birthing large-brained, helpless infants with a fetal pattern of brain growth for a year after birth. Thus, the human infant is more than any other primate dependent on maternal (parental) care. Lactational amenorrhea has evolved as one adaptive mechanism for spanning the birth interval preserving the health of mother and child [ 27 , 28 ], another is the mostly unnoticed early pregnancy loss. This reduces maternal costs, which has been of particular importance in early human evolution [ 29 , 30 ]. Thus, it is realistic to assume that aneuploidy is a natural occurrence in early human embryos [ 31 , 32 ]. In other words, maternal meiosis is an error prone process that is sensitive to endogenous factors, as exemplified by maternal age, but also to recombination events in the maternal meiotic prophase as prerequisites for proper chromosome separation towards opposite poles [ 6 , 33 , 34 ]. Moreover, it is logical to assume that this process can also be affected by exogenous factors, especially by exposure around the time of conception.

Numerous studies suggested that trisomy 21 could be induced by environmental factors (recently reviewed by [ 5 , 35 , 36 , 37 ]), but confirmatory evidence and generally accepted associations are missing so far. “The possibility that human aneuploidy may be induced by environmental factors such as smoking, drinking, oral contraceptive use and radiation exposure has been suggested by data from human studies over many decades …, but confirmatory evidence for these or any other agent has never emerged” [ 38 ]. High coffee consumption was even associated with an inverse effect, explained by reduction of DS conceptus viability [ 39 ]. In statements from 2022, addressed to the general public, The National Down Syndrome Society states “There is no definitive scientific research that indicates that Down syndrome is caused by environmental factors or the parents’ activities before or during pregnancy” [ 40 ] and the Mayo Clinic claims “There are no known behavioral or environmental factors that cause Down Syndrome” [ 41 ]. In this context the actual report of Reece & Hulse [ 42 ] that cannabinoid consume could increase the DS risk might be worth noting in the public discussion on cannabis legalization. Moreover, for epidemiological monitoring of DS the influence of socio-cultural and territorial variables is mostly unclear and only the impact of antenatal screening is evident [ 43 ].

In our opinion, the discrepancy between the generally accepted extreme sensitivity of trisomy 21 (and aneuploidy in general) to endogenous factors and the missing acceptance of causal exogenous factors is not biologically founded but mainly due to inherent problems of appropriate epidemiologic studies. The proof of an environmental agent is a great challenge, both with respect to ascertainment bias, including dosage and time of exposure but also with regard of the relevant co-factors affecting the birth prevalence, especially the strong maternal age effect and prenatal diagnostics with subsequent termination of pregnancy, as well as the high spontaneous loss of fetuses with DS. Moreover, it cannot be excluded that special groups of women exist with genetic disposition to different exposures. In addition, in case of only moderate exposure the population size might be too small and proper controls missing to detect clusters with a significant DS increase.

Clearly, there is an urgent need for epidemiological studies with respect to environmental hazards, including teratogens, affecting birth defects, both from a public health perspective of risk avoidance and primary prevention. In principle, monitoring of trisomy 21 as a sentinel phenotype could be a reliable and efficient approach and, as outlined below, also concerning its broader predictive value. The feasibility depends on standardized data collection and the reliability of ascertainment. In the nearer future these methodical premises will be clearly improved, both due to the establishment of electronic health registers and to the introduction of non-invasive prenatal tests.

The large number of efforts to establish an open data infrastructure for health data (e.g. initiated in 2020 by Gaia-X and accelerated by the COVID-19 pandemic) could be a breakthrough for a monitoring project with anonymous data and the identification of risk factors by pseudonymized documents. The use of electronic health records will provide data of unprecedented power, not only for individual clinical care and public health but also for biomedical research. Clearly, individual patient health data are sensitive and must be carefully safeguarded, whereas population health data are a highly valuable resource for basic and clinical research. Any Health Information Technology (HIT ) system for health care must strive to balance these countervailing demands [ 44 ]. Moreover, a close collaboration with the relevant genetic support groups and their input into research could promote the translation of these studies towards clinical benefit [ 45 ].

With respect to ascertainment, the introduction of the non-invasive prenatal test (NIPD) for DS, based on fetal cell‐free DNA in mother´s blood from 10 weeks in pregnancy, offers a new approach. It has already shifted the national prenatal screening program of the Netherlands [ 46 ] and Belgium. NIPD is offered to all pregnant women in Belgium with an uptake above 75% [ 47 ]. This has enormous implications for DS diagnostics and monitoring, of course in due consideration of the guiding principles for the ethical, legal and social implications [ 48 ].

It is not the aim of this article to present a comprehensive review on the vast literature about possible exogenous risk factors of trisomy 21, but to illustrate the feasibility to identify these factors on a few instructive examples, also concerning its predictive value for other congenital disorders.

Lessons from Down syndrome in Oman

An exemplary study on DS monitoring has been performed in the Sultanate of Oman from 2000 to 2004, both from an epidemiological and molecular point of view [ 49 ]. The Sultanate has 1.8 Mio nationals and a comprehensive health care system. More than 95% of approximately 40,000 births per year are examined by pediatricians, who prompt a cytogenetic analysis for confirmation of DS at the National Cytogenetic Service in Muscat. In about 90% of all cases the clinical diagnosis was confirmed cytogenetically within 6 months after birth. Ascertainment of DS can be considered almost complete. During this time, prenatal diagnostics and selective terminations of pregnancies did not play any role, birth control perhaps only a negligible role, an almost unique situation for DS monitoring. The mean number of pregnancies at birth for mothers of a child with DS was 8.7, range 1- 17 pregnancies. The mean age of DS mothers was 33.5 years and the mean age at first pregnancy 18.2 years.

From 2000 to 2004 the total number of live births was 200,157 and the number of DS cases 518. The average annual prevalence of free trisomy 21 was 1: 383 among newborns or 2.61 per 1,000 live births, which is one of the highest worldwide (see: International Clearinghouse for Birth Defects Monitoring Systems, Annual Report 2003).

Based on the maternal age-related risk for DS, the expected number of DS cases in Oman from 2000 to 2004 would be about 400, which is significantly less than the observed number of 518. The sex ratio with 1.31 was significantly different from that of the Omani controls with 1.06 ( P  = 0.002) and the unaffected sibs with 1.09.

Interestingly, there were significant differences of the DS prevalence between the ten health regions of Oman. Altogether, three distinct clusters could be identified (Fig.  2 ). The DS cluster with the highest prevalence showed a ratio of 1: 304 (301 DS cases among 91,559 newborns), the middle cluster a ratio of 1: 381 (89 DS cases among 33,900 newborns), and the lowest cluster a ratio of 1: 584 (128 DS cases among 74,698 newborns). The mean maternal age of 34.7 years in high prevalence regions was not different from that of the low DS prevalence regions with 33.9 years. The cluster with the highest DS prevalence had also the highest DS sex ratio of 1.35, followed by 1.30 of the middle and 1.24 of the low DS prevalence cluster. The difference to the unaffected newborns is highly significant ( p  < 0.002).

a Prevalence of Down syndrome (DS) in the 10 Omani regions from 2000 to 2004 per 10,000 newborns. Three different clusters could be identified: (red) highest, (dark yellow) middle, (blue) lowest DS birth prevalence/10,000 newborns. b DS sex ratio of the 3 cluster, c DS prevalence per 10,000 newborns for each region, assigned to the three clusters. The lines represent the mean value. The differences are highly significant ( p  < 0.0001; after [ 49 ], modified)

Interestingly, there was also a distinct monthly variation of the DS prevalence with the highest values in January, followed by December (Fig.  3 a). Moreover, the cluster with the highest DS prevalence showed the most distinct seasonal variation with 1 DS per 147 newborns in January, while the cluster with the low DS prevalence has rather uniform monthly values. In addition, the highest sex ratio with 1.91 was also found in January in the cluster with the highest DS prevalence (Fig.  3 b).

Monthly birth prevalence of Down syndrome (DS) in Oman from 2000 to 2004 ( N  = 518). a. All DS newborns. b. The regions with the highest DS prevalence South Batinah and Dakhliya (dark columns) and the regions with the lowest prevalence North Batinah, South Sharqiyah and Dhofar (light columns).The arrow points to January, the month with the highest prevalence (1 DS per 147 newborns; after [ 49 ], modified)

Moreover, the molecular-cytogenetic analysis of 338 cases showed that the cluster with the lowest DS prevalence had also the lowest number of maternal MII errors (18.8%), in contrast to the two other clusters with 37.3% (middle) and 31.5% (high DS prevalence). Altogether, 88.2% of all trisomies are of maternal, 8% of paternal meiotic nondisjunction, and 3.8% are due to mitotic nondisjunction.

The molecular analysis of short tandem repeat (STR) heteromorphisms of chromosomes 21 and Y and the sequence variation of the mitochondrial D-loop from 244 mothers showed that the rate of heterozygosity is almost identical with that published at the National Center for Biotechnology Information (NCBL). This indicates that the Omani population is genetically highly admixed, obviously due to extensive migration in ancient times. The rate of consanguinity of DS couples was not different from that of the general Omani population.

In addition, a case–control study on 90 cases and 90 matched controls (date of birth and region) was undertaken, covering amongst others socio-demographic data, information on menstrual history, individual and family health, exposure to X-rays, and occupational history. There were no obvious differences between cases and controls, e.g. approximately 70% of women in both groups were housewives and none of the women underwent special X-ray diagnostics or X-ray treatment.

The regions with the highest prevalence span the southern part of the coastal region at the Gulf of Oman, which is the most densely populated and principal agriculture area in Oman. A reporting bias as explanation for this January peak can be largely excluded as well as other confounders, such as maternal age, termination of pregnancy, or the rate of consanguinity. Consequently, an environmental cause is the most likely explanation for the December/January peak, almost confined to the cluster with the high DS prevalence, the high sex ratio, and the high rate of maternal MII nondisjunction. So far, no environmental factors have been identified that could explain this seasonal effect.

A possible candidate could be the intensive application of pesticides for agriculture protection [ 50 , 51 ]. The increasing use of pesticides has been of particular concern in Oman, both in terms of human health and impacts on the environment. In 2006 the Pesticides Law regulated the application of pesticides, including the procedures for pesticide management and registration [ 52 ]. If the extensive use of pesticides in the past and the rate of DS in the high prevalence cluster are causally related, the restrictive use of pesticides should also decrease the DS rate. In this case, monitoring of trisomy 21 at this time could in retrospect through light on a health problem, apart from its reassuring effect.

Altogether, the significant regional and seasonal differences in DS prevalences, correlated with the sex ratio and MII errors and without relevant differences in the sociodemographic data, clearly point to an environmental causation.

Lessons from Down syndrome near waste-disposal sites

The potential health risk of people living close to waste-disposal sites received great public attention, not least to the Love Canal Tragedy in the USA with hundreds of families even residing on contaminated land [ 53 ]. The exposure may be due to chemicals, like heavy metals, pesticides, carcinogens, and solvents released into the air, water and soil. This prompted the European collaborative study of hazardous waste disposal in landfill sites and risk of congenital malformations (EUROHAZCON) to perform two systematic studies, based on official registers of congenital anomalies in an area of 7 km radius around about 20 European landfill sites. The studies are based on the assumption that the exposure is higher in a proximate zone of 0–3 km than at 3–7 km distance from the waste landfill site. The cases with congenital anomalies (livebirths, stillbirths and termination of pregnancy with chromosomal anomalies) were classified according to the International Classification of Disease (ICD). In a first study only non-chromosomal congenital anomalies were included and as controls for each case two live births, born on the nearest following day in the 7 km area [ 54 ]. In a second study chromosomal congenital anomalies were recorded, amongst them 127 cases with Down syndrome, 38 living within 3 km of a waste-disposal site, and as controls 2,308 live births born in the same year [ 55 ].

There is a higher risk of trisomy 21 (DS) for families living close to the waste landfill sites and the increase is comparable with that for non-chromosomal anomalies (Table 1 ). The odds ratio for all non-chromosomal anomalies with 1.37 (1.33 adjusted for socioeconomic status and maternal age) is similar to the odds ratio for trisomy 21 with 1.33 (1.36 adjusted for maternal age).

If these results are not due to chance or a common bias, a direct relationship between residence near hazardous waste landfill sites and the increased risk for congenital anomalies remains as plausible explanation. The epidemiological approach, based on fixed thresholds in space to the place of delivery, is convincing. Clearly, the similarity in the risk estimates between cases with trisomy 21 and non-chromosomal anomalies does not point to a common underlying mechanism but illustrates the suitability of trisomy 21 as a sentinel phenotype. In this context, it is relevant that the global trade with hazardous waste from 2001 to 2019 in 28 countries is characterized by improper handling and still of high risk for human health [ 56 ].

Lessons from Down syndrome after the Chernobyl reactor accident

After the Chernobyl accident in April 1986 the population of large parts of Europe was exposed to additional ionizing radiation (IR). While exposure to air-borne, short-lived radionuclides was limited to about two weeks, long term exposure, mainly due to caesium radioisotopes, lasted for many years. According to a global risk study on the health effect of the Chernobyl reactor accident "probably no adverse health effect will be manifest by epidemiological analysis" outside of the Chernobyl region [ 57 ]. In 2000 the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) stated: „Several studies on adverse pregnancy outcomes related to the Chernobyl accident have been performed …. So far, no increase in birth defects, congenital malformations, stillbirths, or premature births could be linked to radiation exposures caused by the accident “ [ 58 ]. This also refers to the increase of DS in West-Berlin, in Scotland and Sweden. According to the UNSCEAR report these observations were later challenged by a study published in 1997 [ 59 ]. With respect to DS the data of this study were collected from children´s hospitals in Bavaria. The inclusion criterion was treatment for congenital malformation within the first two years of life. Not all cases were cytogenetically confirmed and no prenatally diagnosed fetuses included. Thus, from an epidemiological point of view, DS recording is incomplete and in contrast to the ascertainment of DS in West-Berlin.

From an epidemiological point of view, the situation in West-Berlin, an “island” surrounded by the GDR, was unique, regarding the recording of trisomy 21 until the fall of the Wall in 1989. One university institute was responsible for genetic counseling and cytogenetic diagnostics, including prenatal diagnostics. More than 90% of all newborns with trisomy 21 were cytogenetically diagnosed already 10 days after birth. The age distribution of all mothers and of all pregnant women, who made use of prenatal diagnostics, was known [ 60 ].

During the 10 years from 1980 to 1989, the average monthly prevalence of trisomy 21 in West-Berlin was 2–3. In January 1987, 12 cases were observed, 10 newborns and 2 prenatally diagnosed fetuses. This increase was significant ( p  < 0.01) and occurred exactly 9 months after the Chernobyl reactor accident [ 60 ]. In an independent study in Germany in 1986, based on 28,773 prenatal diagnoses due to maternal age, the highest incidence of trisomy 21 concerns fetuses that were conceived in the same critical period as in Berlin and in the most heavily contaminated southern part of Germany (11 instead of the expected 4 cases). In the northern, almost unexposed part, the ratio between observed and expected cases was 6 to 5 [ 61 ].

In January 1987 the monthly prevalence of Down syndrome among life births in Belarus also showed a highly significant peak (Fig.  4 ). Here again, ascertainment between 1981 and 1992 was high, prenatal diagnostics not performed and maternal age known [ 62 ].

Raw (circle) and age adjusted (dot) monthly birth prevalence of Down syndrome from January 1981 to December 1992 in Belarus ( N  = 1,720,030; n  = 1791) and West Berlin ( N  = 218,497; n  = 237) based on a change point model allowing a decreasing trend with a peak in January 1987 and a jump, i.e. a level shift, for 1987 to 1992. Belarus: OR peak p  < 0.0001, OR jump p  = 0.0001; West Berlin: Or peak p  < 0.0001, OR jump p  = 0.378 [from 64]

The spatial distribution of children with trisomy 21, born in January 1987 in Belarus, followed the radioactive cloud’s passage within the first post-accident days. The same was true for Berlin. When the clouds from Chernobyl passed over, the weather was dry and sunny and the only exposure of the population was due to the inhalation of short-lived radionuclides, in particular iodine 131 (physical half-life 8 days, biological half-life even less), for most of the DS mothers exactly at the time of conception. Since Belarus and Berlin are countries with a high prevalence of iodine deficiency, the uptake of radioactive iodine was higher than in most other European countries and could be about 0.05 mSv during the critical two weeks.

In both areas, the most important confounders, such as maternal age distribution, number of prenatal diagnostics, and completeness of ascertainment could be excluded. Moreover, also the generally recognized criteria of Bradford Hill [ 63 ] are fulfilled: strength of the association, specificity, relationship in time, consistency, biological gradient (dose–effect-relationship), experimental evidence, biological plausibility, and reasoning by analogy.

In addition, a long-term effect was also observed in the first post-accident years, not only in Belarus but also in several other European countries or regions, such as Bavaria in Germany, the Lothian region of Scotland, North-West England, Hungary, and Sweden. This effect has been explained by exposure, especially to Caesium-137 (physical half-live 30 years), which reached its maximal uptake about 1 year after the Chernobyl accident [ 64 ].

The January 1987 peaks of DS in Berlin and Belarus represent a strong association, any relevant bias or confounder should be easily identifiable. The long-term effect is less distinct, but characterized by its uniform beginning in 1987 , making an artefact rather unlikely. This long-term effect may be even more important than the January peak from a public health point of view. Thus, the Chernobyl effect is exceptional, both with respect of its specificity in time and reproducibility, leading to the assumption of a causal relationship between low-dose irradiation and meiotic nondisjunction in man. Actually, there is good evidence for an inverse dose–effect relationship according to which also other types of hereditary defects, cancers included, could be increased after low dose of irradiation [ 65 ].

Moreover, in West-Berlin in January 1987 the sex ratio among the 10 DS newborns was 8 males to 2 females. Interestingly, in the years following the Chernobyl accident, a significant increase in the sex ratio, confined to the exposed European countries and Cuba, has been documented, which is due to a decrease of female newborns [ 66 , 67 , 68 , 69 ]. In Bavaria, this increase of male births was already observed in January 1987, whereby this effect was higher in the more heavily exposed southern part (6.9%) than in the northern part (3.5%) [ 70 ]. The critical stage for this shift is the time around conception. The increase in the sex ratio after exposure to low dose of ionizing radiation has been explained by an epigenetic effect, defective X-inactivation, resulting in a loss of female embryos [ 71 ]. The phenomenon of male excess in DS has been explained by co-orientation of chromosomes Y and 21 in male meiosis, a greater accessibility of Y-sperm to a disomic zygote or to post-fertilization events leading to selection against females, as in case of defective X-inactivation [ 20 ].

It should be added that also other health effects after in utero exposure by the Chernobyl fallout had been documented in Germany, e.g. an increase of stillbirths and congenital malformations (Table 2 ). Especially in Bavaria, a dose-dependent significant increase of congenital malformations, beginning in 1987, was documented [ 72 ].

With respect to ascertainment of trisomy 21 the “island” situation of West Berlin was exceptional. Diagnostics of trisomy 21 was part of the regular medical service and supported by the excellent official health statistics provided by the Senate of West Berlin. It can, perhaps, serve as a model for monitoring of trisomy 21, nearly without any additional costs. In addition, it is one of the few cases where the impact of the environmental factor was limited to the time of conception.

Lessons from a Down syndrome cluster in Hungary

In 1991/1992 in Rinya, a small Hungarian village with 456 inhabitants, 11 of 15 newborn had congenital anomalies, among them 4 with Down syndrome (2 were monozygotic twins). Of 61 children born between 1980 and 1988 only 3 had malformations. The 10 children born in 1991/92 were healthy [ 73 ].

Apart from the 4 cases with Down syndrome, the other probands had different anomalies, which could be assigned to critical embryonal periods (Table 3 ). A familial genetic disposition, consanguinity, or a chance event could be virtually excluded. The most likely explanation was the impact of a teratogenic factor.

The exemplary population-based “Hungarian Congenital Abnormality Registry” proved that the cluster was confined to this small village. The following environmental investigation disclosed the excessive use of trichlorfon, an organophosphorus insecticide for eradication of parasites, at local fish farms. Several pregnant women had consumed contaminated fish in the critical period for the congenital anomalies observed, the mothers of the children with DS around conception. The molecular analysis showed an MII error in two cases, one was not informative (Table 3 ). The concordance between the time of exposure and the most sensitive time for the induction of the different malformations was another argument for a causal relationship. When the trichlorfon treatment of the fish was banned, the cluster ceased.

Clearly, this was a retrospective study, an observational approach after the cluster has ended. Nonetheless, the concordance between the time of exposure and the most sensitive time for the induction of the particular malformation not only points to a causal relationship but illustrates that monitoring of trisomy 21 might also be relevant for the understanding of teratogenic effects and applicable to small cohorts.

Concept for population monitoring of Down syndrome

As outlined above, the high rate of maternal meiotic nondisjunction in man, leading to trisomy 21, represents an error prone process. Most cases occur around conception, when also the most profound epigenetic modifications take place. Thus, from an epidemiological point of view, surveillance of trisomy 21 offers a unique chance for monitoring this sensitive process and for identification of endogenous and exogenous risk factors [ 74 ].

For reasons of efficiency (time and money), it is generally desirable to use existing databases, which should include the most important confounders, such as parental age at conception, offspring age and sex at diagnosis, as well as population-based data, such as usage of prenatal screening and termination of pregnancy in case of DS, as well as place of residence.

Concerning the registration of the relevant individual and population health data, the guiding principles developed for the application of genomics to human health and disease can serve as a model [ 48 , 75 , 76 , 77 ]. While individual health data are sensitive and should be safeguarded, population health data are a most important resource for research. A balance has to be found between these countervailing demands, both on a national and international basis [ 58 , 78 ]. The collection, storage, and processing of sensitive health data is the aim of the European digital GAIA-X initiative. It should also enable the connection to other data platforms to further research and health domains ( https://www.data-infrastructure.eu/GAIAX/Redaktion/EN/Artikel/UseCases/smart-health-connect.html ). A vision for the future is the development of differential privacy technology within cloud-sharing communities protecting the privacy of users and resolving the data-sharing problem [ 79 ].

The recent initiatives to help enable and foster data sharing practices for pediatric research and translate these into practice, also with respect to consent clauses, are reviewed by Patrinos et al. [ 80 ]. Today, Denmark has perhaps one of the most effective health systems, based on the establishment of a national e-health portal, sundhed.dk, providing patient-oriented digital services. The Danish Health Data Authority’s Research Services supports health research in Denmark by providing access to register-based health data via a secure research platform [ 81 ]. Also the Western Australian Data Linkage System (WADLS), instigated in 1995, can serve as a model to link local health and welfare data sets, genealogical links, and spatial references for aetiologic research, disease surveillance and methodic research [ 82 ]. This register combines information related to antenatal and perinatal factors, contains all registered births, and provides information related to parental age. In addition, it provides information on all registered deaths and causes of mortality. Each individual congenital anomaly is coded using the International Classification of Diseases system [ 83 ]. The WALDS is used intensively and receives a high level of social acceptance, which is based primarily on the involvement of a wide variety of social groups, including patient self-supporting groups. Clearly, these initiatives, such as WALDS, can also serve as model for a monitoring project with DS data and the identification of risk factors.

Concerning the reliability of DS ascertainment, the most important aspect is that the DS birth prevalence is counterbalanced by the number of pregnancies that are terminated due to the availability of prenatal screening. In 2011, sequencing of cell-free DNA in maternal serum as a sensitive, non-invasive screening technique (NIPD) has been developed, which can be performed already at 10 weeks of gestation. Until 2020 about 10 million tests have been performed [ 5 ]. The prediction rate of trisomy 21 is superior to first trimester combined screening based on maternal age, fetal nuchal translucency thickness (NT) and serum markers [ 84 ]. The positive predictive value for NIPD was significantly higher than that for standard screening (45.5% vs. 4.2%, [ 85 ]; (80.9% vs. 3.4%, [ 86 ]. Thus, the positive predictive value for trisomy 21 is significantly improved, explaining its broad application worldwide. Moreover, the average fetal loss rate between the time of NIPD/ chorionic villus sampling and term is more than 30% [ 87 ]. Thus, the monitoring efficiency is also increased in comparison to newborn screening. NIPD, however, is not a diagnosis and needs confirmation by invasive diagnostic testing [ 88 ]. If, in the future, this diagnosis is no longer carried out cytogenetically but by whole genome sequencing, this would open up entirely new possibilities for the identification of genetic risk factors.

The implementation of NIPD differs between market-based and state-sponsored health systems [ 89 ]. Today, this test is already offered in Belgium and the Netherlands to all pregnant women [ 46 , 47 ]. Here is not the place to discuss the ethical/cultural implications of prenatal diagnostics and reproductive autonomy, both with respect of termination of a DS fetus but also concerning the benefits to initiate early treatment [ 5 ]. Clearly, for population monitoring of trisomy 21 NIPD offers completely new aspects with respect to population-wide ascertainment in early pregnancy. Moreover, direct haplotyping has been successfully applied for NIPD of monogenic disorders [ 90 , 91 , 92 ] including triplet-repeat expansion diseases [ 93 ]. Based on the significant progress of NIPD in the past few years, it is realistic to assume that in the future haplotyping of aneuploidies is possible as well as differentiation between MI and MII errors.

For population monitoring of DS an ecological study is applicable as generally used in public health research. The results should be evaluated by the Bradford Hill criteria in case of a causal suspicion. A case–control study, however, has greater power to identify specific (environmental) risk factors. Due to its retrospective nature, case–control studies are subject to recall bias, but are inexpensive, efficient, and especially suitable for rare diseases [ 94 ]. The Hungarian study in 1991–1992 is a paradigm of this approach [ 73 ]. Based on the Hungarian Congenital Abnormality Registry, the history of the mothers of these cases could be obtained with little extra effort. In this case the “controls” were the 60 offspring born before and after the critical period.

Generally, in case–control studies the cases are the families with an affected child and the controls those with an unaffected child. Based on personal interviews with a structured questionnaire of 50 mothers, who gave birth to a child with trisomy 21, and 272 controls the highest odds ratios were found for thyroid scan and the investigations of the pelvis and the abdomen. About 90% of cases of the study population and contacted controls participated, underlining the feasibility of this approach [ 74 ]. In an extensive comparison of odds ratios using affected and unaffected controls there was no evidence that differential recall of exposure has an important implication in case–control studies of birth defects [ 95 ].

If the health data are routinely collected as in Western Australia, case control studies on trisomy 21 can be performed without any extra efforts and, apart from the monitoring aspect, pave the way for applied research concerning causally relevant environmental factors but also with respect to basic research related to relevant genomic variants and, perhaps, help to explain the increase of the sex ratio.

Trisomy 21 is a singular resource to understand meiotic nondisjunction and its endo- and exogenous risk factors in humans, as it is one of the few aneuploid conditions that is recorded at early embryogenesis and can, in principle, survive to term. Thus, monitoring of trisomy 21 as sentinel phenotype for congenital anomalies in general, offers new chances for preventive measures. The epidemiological prerequisites with respect to completeness of ascertainment, consideration of the relevant confounders, and application of appropriate statistical approaches are still challenges. Nonetheless, the advents in molecular genetics including non-invasive prenatal screening and the global initiatives for the implementation of health data registers offer most promising chances for basic medical research.

Availability of Data and Materials

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Abbreviations

• Down syndrome

Dizygotic twins

European Surveillance of Congenital Anomalies

Federal Republic of Germany

German Democratic Republic

Health Information Technology

International Classification of Disease

Ionizing radiation

First meiotic division

Second meiotic division

Monozygotic twins

National Center for Biotechnology Information

Non-invasive prenatal test

Restriction length polymorphism

Short tandem repeats

Western Australian Data Linkage System

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Design, conception and first draft of the manuscript: KS Biostatistics and sex ratio: HS; HN was involved in the cited Oman study, all authors in the Chernobyl study. Critical revision and approval of the final manuscript: all authors. Both authors read and approved the final manuscript.

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Sperling, K., Scherb, H. & Neitzel, H. Population monitoring of trisomy 21: problems and approaches. Mol Cytogenet 16 , 6 (2023). https://doi.org/10.1186/s13039-023-00637-1

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Received : 27 December 2022

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DOI : https://doi.org/10.1186/s13039-023-00637-1

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