Arkansas Gov announces education reform plan

 Arkansas Gov. Sarah Huckabee Sanders announced her Arkansas LEARNS plan for education reform to raise teachers’ salaries to a minimum of $50,000 and give schools resources to increase literacy and career preparedness. 

“This is the most substantial overhaul of our state’s education system in Arkansas history and frankly it couldn’t come soon enough,” Sanders said Wednesday. 

The new governor teased the reform package Tuesday night in the official Republican response to the State of the Union. 

“As I said in my remarks, I believe that giving every child access to a quality education is the civil rights issue of our day,” Sanders said, referring to her national address the night before. 

The Arkansas LEARNS plan will not only include the new minimum salary for teachers, but bonuses for high-performing teachers as well.The plan will also add support such as  complete student loan forgiveness for Arkansas teachers, adding reading coaches in schools and providing $500 tutoring grants for schools with students who are not meeting early education “reading benchmarks,” Sanders said. 

She also promised to give parents a choice as to where their children attend school, “whether it be public, private, parochial or home-school.” 

Sanders nodded to but didn’t fully address Republicans’ concerns regarding critical race theory and book bans in states like Florida, Texas and Virginia. 

“We will never subject our kids to indoctrination and we will never, ever expose our young children to inappropriate material,” Sanders said. “Most importantly, this legislation ensures that every Arkansas student graduates with the education and training they need to succeed in life.”

The Arkansas governor said the announcement is delivering on her campaign promise to make education the “hallmark” of her administration as governor. 

Arkansas LEARNS, Sanders said, is a “comprehensive blueprint to meet teachers’ needs, respect parents’ rights and most importantly deliver the quality education that our kids deserve.”

https://thehill.com/homenews/state-watch/3850181-arkansas-gov-announces-education-reform-plan/

UK view: Biden agenda clashes with reality of divided Congress

 President Joe Biden may not be out of ideas for how to deliver on his economic promises. But he does seem to be out of time.

In his State of the Union address, the president urged lawmakers to "finish the job" - calling for a new tax on the super wealthy, a crackdown on Big Tech companies, and other financial support for families, including family and medical leave.

For those following the issues, it was an oblique way of acknowledging that many of those proposals had already been presented in the last two years and failed to advance, despite Democrats having control of both houses of Congress.

With Republicans now holding a majority in the House of Representatives, the chances of them becoming reality have only lessened.

"A lot of them were not serious legislative proposals - they were campaign points and politics," said Douglas Holtz-Eakin, president of the American Action Forum, a centre-right think tank in Washington. Of the tax increases, he added: "None of those things have a chance of turning into law."

Mr Biden does have some big victories from the last two years to champion - $550bn (£455bn) that the federal government will steer to roads, bridges and other infrastructure projects; $280bn for investments in high tech manufacturing and other research and development; and another nearly $400m for green energy technologies.

But despite those wins, a recent poll by the Washington Post-ABC News found that Republicans and independents overwhelmingly viewed the president as having accomplished little during his time in office. Even 22% of Democrats shared that view.

Analysts said it will be hard to change that perception in the next two years.

Business groups are already pushing back hard against some of the regulatory changes Mr Biden has proposed, such as curbing so-called "junk" fees that banks, airlines and others charge customers, or barring so-called non-compete agreements, which limit the ability of employees to go work for rival businesses.

"Overregulation will stop progress in its tracks," US Chamber of Commerce president Suzanne Clarke wrote on Twitter in response to the president's speech.

Even on issues where there might seem to be appetite for action in both parties, few are expecting results.

The president's call for action on Big Tech drew applause from both Republicans and Democrats, for example, but talk in Congress on new rules dating back to the Trump administration has yet to produce change.

Last year, Republicans and Democrats also tried to negotiate a deal that would grant tax changes favoured by business in exchange for expanding the child tax credit, a tax break for families that was credited with lifting millions of children out of poverty when Congress increased it as part of its pandemic relief programme.

Those talks also failed.

"The president doesn't get to pass legislation on his own," said Elaine Maag, senior fellow at the Urban Institute, a Washington think tank focused on issues of equity and opportunity.

"I'm confident that in the Senate there are more than 50 votes to pass an expanded tax credit .... I'm much less confident that there are enough votes in the House for a big piece of legislation like that right now."

Elaine Kamarck, a senior fellow at the left-leaning Brookings Institution, says people should not be so quick to write off the president's chances, noting that with such a narrowly divided Congress getting some of his proposals through would only take a few votes.

Republicans have become a more populist party than they were just a few years ago, she added.

"This is not your grandfather's Republican Party where they were all businessmen or Wall Streeters, so you can see a few votes getting picked off," she said.

But Mr Holtz-Eakin said the White House was scaling back its economic message from the big ambitions that Mr Biden ran on for president.

"I think there's a realisation that the Build Back Better agenda was too big. It never really did add up and the American people don't support it," said Mr Holtz-Eakin, pointing to the president's approval ratings, which continue to hover in the low 40%.

Indeed Mr Biden mentioned some of the biggest issues for the progressive Democratic base - such as family and medical leave and student debt relief - only in passing. Raising the minimum wage did not get a nod at all.

Dean Baker, senior economist at the progressive Center for Economic and Policy Research, said Mr Biden is treading a careful path of celebrating his accomplishments without drawing too much attention to the defeats.

"He knows he's not going to get much through this Congress and it doesn't make sense to throw all these things out there that they're just going to ignore," he said. "I think he's just being realistic."

https://www.bbc.com/news/business-64576224

Molina guidance above views

 Full Year Highlights

• As of December 31, 2022, the Company served approximately 5.3 million members.

• Premium revenue was $30.9 billion for the full year 2022, an increase of 15% year over year.

• GAAP earnings were $13.55 per diluted share, an increase of 20% year over year. GAAP earnings include a fourth quarter non-cash, after tax impairment charge of $159 million, or $2.72 per diluted share, attributable to the Company’s plan to reduce its leased real estate footprint.

• Adjusted earnings were $17.92 per diluted share, an increase of 32% year over year.

• The Company issued its full year 2023 earnings guidance with expected premium revenue of $32 billion and adjusted earnings of at least $19.75 per diluted share. Earnings guidance includes $0.65 per diluted share of one-time, non-recurring, implementation costs for new Medicaid contract wins.

https://finance.yahoo.com/news/molina-healthcare-reports-fourth-quarter-211500571.html

IVF-Conceived Children Show Strong Developmental Performance

 In vitro fertilization has been around long enough that researchers can now compare developmental and academic achievements between these children and peers at school age. 

Amber Kennedy, MBBS, and colleagues did just that. They found little difference in these milestones between a total of 11,059 IVF-conceived children and 401,654 spontaneously conceived children in a new study.

"Parents considering IVF and health care professionals can be reassured that the school age developmental and educational outcomes of IVF-conceived children are equivalent to their peers," says Kennedy, lead author and obstetrician and gynecologist at Mercy Hospital for Women at the University of Melbourne, Australia. 

The findings were published online Jan. 24 in the journal PLOS Medicine. 

"Overall, we know that children born through IVF are doing fine in terms of health, but also emotionally and cognitively. So I wasn't surprised. I live in this world," says Ariadna Cymet Lanski, PsyD, chair of the American Society for Reproductive Medicine Mental Health Professional Group, who was not affiliated with the study.

Some previous researchers linked conception via IVF to an increased risk of congenital abnormalities, autism spectrum disorder, developmental delay, and intellectual disability.

Asked why the current study did not find increased risks, Kennedy says, "Our population included a relatively recent birth cohort, which may explain some differences from previous studies as IVF practices have evolved over time." 

An estimated 8 million people worldwide have been conceived through IVF since the first birth in 1978, the researchers says. In Australia, this has grown from 2% of births in the year 2000 to now nearly 5% or 1 in 20 live births, Kennedy says. "Consequently, it is important to understand the longer-term outcomes for this population of children."

Along with senior author Anthea Lindquist, MBBS, Kennedy and colleagues studied 585,659 single births in Victoria, Australia, between 2005 and 2014. They did not include multiple births like twins or triplets.

The investigators compared 4,697 children conceived via IVF and 168,503 others conceived spontaneously using a standard developmental measure, the Australian Early Developmental Census (AEDC). They also assessed 8,976 children in the IVF group and 333,335 other children on a standard educational measure, the National Assessment Program–Literacy and Numeracy (NAPLAN).

For example, the developmental census measures developmental vulnerability. Kennedy and colleagues found a 0.3% difference in favor of IVF-conceived children, which statistically was no different than zero.

Similarly, the researchers report that IVF conception had essentially no effect on overall the literacy score, with an adjusted average difference of 0.03.

Lanski says the results should be reassuring for people considering IVF. "I can see the value of the study." The findings "probably brings a lot of comfort...if you want to build a family and medically this is what's recommended." 

Not all IVF techniques are the same, and the researches want to take a deeper dive to evaluate any distinctions among them. For example, Kennedy says, "We plan to investigate the same school-aged outcomes after specific IVF-associated techniques." 

Sources:

PLOS Medicine: "School-age outcomes among IVF-conceived children: A population-wide cohort study."  

Amber Kennedy, MBBS, University of Melbourne, Australia.

Ariadna Cymet Lanski, PsyD, American Society for Reproductive Medicine.

https://www.medscape.com/viewarticle/987978

In Adults With Prediabetes, Vitamin D Cuts Diabetes Risk

In adults with prediabetes, vitamin D helped decrease the risk that these individuals would develop diabetes, suggests a meta-analysis of three trials.

Results of the analysis, led by Anastassios G. Pittas, MD, MS, with the division of endocrinology, diabetes, and metabolism at Tufts Medical Center, in Boston, were published online in Annals of Internal Medicine (2023 Feb 7. doi: 10.7326/M22-3018).

All three eligible trials included in the analysis were randomized, double blinded, and placebo controlled. The three eligible trials tested three oral formulations of Vitamin D: cholecalciferol, 20,000 IU (500 mcg) weekly; cholecalciferol, 4,000 IU (100 mcg) daily; or eldecalcitol, 0.75 mcg daily, against placebos.

The authors of the new paper found that vitamin D reduced the risk for diabetes in people with prediabetes by a statistically significant 15% in adjusted analyses. The 3-year absolute risk reduction was 3.3%.

They found no difference in the rate ratios for adverse events (kidney stones, 1.17, 95% confidence interval, 0.69-1.99; hypercalcemia, 2.34; 95% CI, 0.83-6.66]; hypercalciuria, 1.65; 95% CI, 0.83-3.28]; death, 0.85; 95% CI, 0.31-2.36]) when study participants got vitamin D instead of placebo.

Differences from previous analyses

The relationship between vitamin D levels and risk for type 2 diabetes has been studied in previous trials and results have been mixed.

The authors note that two previous meta-analyses included trials "that had relatively short durations for assessment of diabetes risk (for example, ≤ 1 year), had high risk of bias (for example, open-label trials), or were not specifically designed and conducted for primary prevention of type 2 diabetes, potentially undermining the validity of the results."

Each of the trials in this meta-analysis had a low risk of bias as determined by the Cochrane risk-of-bias tool, Dr. Pittas and colleagues said.

"The present study does not reach an opposite conclusion from the D2d study," said Dr. Pittas, who coauthored that paper as well. "Rather, it confirms the results of the D2d study. In D2d and two other similar vitamin D and diabetes prevention trials (one in Norway and one in Japan), vitamin D reduced the rate of progression to diabetes in adults with prediabetes, but the observed differences were not statistically significant because the reported relative risk reductions (10%-13%) were smaller than each trial was powered to detect (25%-36%)."

"Individual participant data meta-analyses increase the statistical power to detect an effect. After combining data, we found that vitamin D reduced the risk of progression from prediabetes to diabetes by 15% and this result was statistically significant. So, the conclusion of the meta-analysis is essentially the same conclusion as in D2d and the other two trials. The difference is that the result is now statistically significant," Dr. Pittas added.

Small reduction but large population

The authors acknowledged that the absolute risk reduction number is small, especially when compared with the risk reduction seen with intensive lifestyle changes (58%) and metformin (31%), as reported in an article published in the New England of Journal of Medicine (2002 Feb 7;346:393-403). But "extrapolating to the more than 374 million adults worldwide who have prediabetes suggests that inexpensive vitamin D supplementation could delay the development of diabetes in more than 10 million people," they said.

As for how high vitamin D levels need to be, the authors write that their research indicates that the optimal level of vitamin D in the blood needed to reduce diabetes risk may be higher than an Institute of Medicine committee recommendation in 2011.

"The blood 25-hydroxy vitamin D level needed to optimally reduce diabetes risk may be near and possibly above the range of 125-150 nmol/L (50-60 ng/mL) that the 2011 Institute of Medicine Committee to Review Dietary Reference Intakes for Calcium and Vitamin D provided as the range corresponding to the tolerable upper intake level (UL) of 4,000 IU/d for vitamin D," the authors of the new paper said.

Editorialists urge caution

In an accompanying editorial also published in the Annals of Internal Medicine, Malachi J. McKenna, MD, with the department of clinical chemistry, at St. Vincent's University Hospital, and Mary A.T. Flynn, PhD, RD, with the Food Safety Authority of Ireland in Dublin, urge caution regarding vitamin D dosing.

They write that there are important distinctions between vitamin D supplements and vitamin D therapy, and the potential harms of high-dose vitamin D are still unclear.

"Vitamin D supplementation of 10 to 20 mcg (400 to 800 IU) daily can be applied safely at the population level to prevent skeletal and possibly nonskeletal disease. Very-high-dose vitamin D therapy might prevent type 2 diabetes in some patients but may also cause harm," they note.

Dr. Pittas said in an interview that there have been some studies with high-dose vitamin D (up to 500,000 IU a year in one study) that reported an increased fall risk in older adults who had high fall risk. "However, these findings are not generalizable to other populations that are younger and at low or average fall risk, such as the prediabetes population to which the results of this meta-analysis apply," he noted.

"The benefit-to-risk ratio for vitamin D depends on the target population and medical condition," Dr. Pittas said. "The editorial refers to the NAM (National Academy of Medicine) vitamin D guidelines for the general, healthy population to promote bone health. The guidelines should not be extrapolated to specific populations, for example [patients with] prediabetes," where the vitamin D benefit-to-risk ratio would be different from that in the general population.

Dr. Pittas and colleagues caution that the people studied in this meta-analysis were at high risk for type 2 diabetes, so these results do not apply to the general healthy population. The results also should not be extrapolated to people at average risk for any type of diabetes, they add.

Dr. Pittas reports the National Institutes of Health and the American Diabetes Association made payments to his institution to conduct Vitamin D-related research. He is an unpaid cochair of the Endocrine Society’s Evaluation, Treatment and Prevention of Vitamin D Deficiency Clinical Practice Guideline team. Coauthor Dr. Jorde reports grants from Novo Nordisk Foundation, North Norwegian Regional Health Authorities, and the Research Council of Norway. Dr. Dawson-Hughes reports she is on the DSMB for AgNovos Healthcare. AgNovos is developing a bone implant to reduce hip fracture risk and she gets a stipend from the company. She reports Helsinn Therapeutics provided anamorelin and matching placebo for an NIH-funded clinical trial. Dr. Trikalinos was supported by the D2d study. He is a technical methodological consultant to Latham and Watkins, who is retained by Pacira Pharmaceuticals. Dr. Angellotti has been employed by Takeda and owns stock in the company. The editorialists report no relevant financial relationships.

https://www.medscape.com/viewarticle/987961

Behind Viral Videos Linking COVID Vaccine to Spasms, Shakes

 Images of uncontrollable tremors, shaking, involuntary spasms. It's a visibly unnerving condition that's recently been going viral on social media. 

Late last month, a video resurfaced from 2021 of Angelia Desselle, a then 45-year-old woman from Louisiana attempting to walk while supposedly experiencing these symptoms, which she claims were developed after receiving a COVID-19 vaccine. This is just one example of many.

Since Desselle's video was reposted on Twitter, it's been viewed more than 72 million times, helping to reignite controversy over the safety of COVID vaccinations. Her original video – first posted on Facebook -- was flagged by the site as part of an effort to combat misinformation, according to Politifact. One of the recent retweets had this context added: "the video … has been debunked by multiple news outlets and local and federal health officials, showing no association of Desselle's alleged 2 days of symptoms with the COVID vaccine."

Yet these types of videos linger. Vaccine skeptics see them as supporting their beliefs that the vaccines are dangerous, despite mountains of evidence to the contrary and international public safety pronouncements.

Aside from outright attempts to mislead, experts have an explanation for the shaking: In many cases, these atypical physical movements can be attributed to a common, disabling condition called functional neurological disorder or FND, according to neurologist Alfonso Fasano, MD, chair in Neuromodulation and Multi-Disciplinary Care at the University of Toronto and University Health Network. 

FNDs are believed to be related to altered brain network activity (that is, disruption in the brain's normal mechanisms for controlling the body), and possibly “triggered by a combination of abnormal physical and psychological experiences," according to the Functional Neurological Disorder Society.

“This is as common as it is poorly understood," says Fasano, who is co-author of a study looking at patients who visited a doctor with neurological symptoms following a COVID-19 infection or vaccination. 

He says many of the patients that he's seen in the clinic (including 43% of study participants) have a functional disorder that sometimes lingers just below the surface and waits for something to trigger it.

“There is really something wrong with them and something wrong in the brain; their brain functions in a different way," says Fasano.

Moreover, while factors like psychological stressors, underlying illness (or infections like COVID-19 and the flu), and past traumas appear to predispose some patients to FNDs, others develop the syndrome without any explicable cause. 

A Perfect Storm

Functional nerve disorders are not a new phenomenon; they've been reported in one form or another since the Middle Ages. Today, an estimated 4% to 12% of the population have them, and it is a common diagnosis in neurology clinics. 

What makes them different this time around is the “perfect storm" – ongoing pandemic stress and fatigue, the social media megaphone and its ability to reach millions of people in real time at the same time, and global vaccination campaigns – all of which make it more common to attribute the development of nerve disorder symptoms to the vaccines. 

“Vaccines have been associated with neuromuscular issues after receipt, but this is a very rare side effect," says Matthew Laurens, MD, MPH, pediatric infectious disease specialist and a professor of pediatrics at the University of Maryland School of Medicine in Baltimore. 

“Guillain-Barré syndrome, a rare disorder where the body's immune system damages nerves, was reported in association with the 1976 swine flu vaccination campaign," he says. But “sometimes events happen to individuals just after they receive a vaccine and they are not at all related to the vaccine."

Neurological events like Guillain-Barré or involuntary muscle twitching (known as myoclonus) have been more frequently reported after infection itself. A study published in the Annals of Neurology last year showed that simply contracting COVID-19 significantly raised a person's risk for neurological events.

“The upshot was that the chances of having a neurological event after catching COVID were roughly 600-fold higher than after being vaccinated, which means for the general population, that it's unlikely that the COVID vaccines are related to a movement disorder," says Jennifer Frontera, MD, study co-author and a neurologist with New York University's Langone Health. 

Even becoming infected by the virus may just reveal what was already under the surface. “There really hasn't been a lot to suggest that COVID itself causes a movement disorder," says Frontera. “I suspect that in some cases, it may unmask a movement disorder."

Fasano agrees. "Like any medical act or minor trauma, anything can trigger functional disorders in people who are at risk for them."

Sources

Twitter: @AngeliaDesselle, Jan. 21, 2023, @seanybrams, Jan. 24, 2023. 

JAMA Neurology: “Current Concepts in Diagnosis and Treatment of Functional Neurological Disorders."

Functional Neurological Disorder Society: “Press release from the Functional Neurological Disorders Society."

European Journal of Neurology: “Functional disorders as a common motor manifestation of COVID-19 infection or vaccination."

Alfonso Fasano MD, chair, Neuromodulation and Multi-Disciplinary Care, University of Toronto and University Health Network, co-director, Surgical Program for Movement Disorders, Toronto Western Hospital, Ottawa, Canada. 

Neurologist: “Functional Neurological Disorders: Clinical Spectrum, Diagnosis, and Treatment."

Matthew Laurens, MD, pediatric infectious disease specialist, professor of pediatrics, University of Maryland School of Medicine, Baltimore.

Jennifer Frontera, MD, neurologist, NYU Langone Health, professor of neurology, NYU Langone School of Medicine, New York City.

Annals of Neurology: “Neurological Events Reported after COVID-19 Vaccines: An Analysis of VAERS."

Movement Disorders Clinical Practice: “Tics and TikTok: Functional Tics Spread Through Social Media."

https://www.medscape.com/viewarticle/987975

Are AI Chatbots in Healthcare Ethical?

 Within a week of its Nov. 30, 2022 release by OpenAI, ChatGPT was the most widely used and influential artificial intelligence (AI) chatbot in history with over a million

opens in a new tab or window registered users. Like other chatbots built on large language models, ChatGPT is capable of accepting natural language text inputs and producing novel text responses based on probabilistic analyses of enormous bodies or corpora of pre-existing text. ChatGPT has been praised for producing particularly articulate and detailed text in many domains and formats, including not only casual conversation, but also expository essays, fiction, song, poetry, and computer programming languages. ChatGPT has displayed enough domain knowledge to narrowly miss passing a certifying examopens in a new tab or window for accountants, to earn C+ grades on law school examsopens in a new tab or window and B- grades on business school examsopens in a new tab or window, and to pass parts of the U.S. Medical Licensing Examsopens in a new tab or window. It has been listed as a co-author on at least fouropens in a new tab or window scientific publications.

At the same time, like other large language model chatbots, ChatGPT regularly makes misleading or flagrantly false statements with great confidence (sometimes referred to as "AI hallucinations"). Despite significant improvements over earlier models, it has at times shown evidence

opens in a new tab or window of algorithmic racial, gender, and religious bias. Additionally, data entered into ChatGPT is explicitly stored by OpenAI and used in training, threatening user privacy. In my experience, I've asked ChatGPT to evaluate hypothetical clinical cases and found that it can generate reasonable but inexpert differential diagnoses, diagnostic workups, and treatment plans. Its responses are comparable to those of a well-read and overly confident medical student with poor recognition of important clinical details.

This suddenly widespread use of large language model chatbots has brought new urgency to questions of artificial intelligence ethics in education, law, cybersecurity, journalism, politics -- and, of course, healthcare.

As a case study on ethics, let's examine the results of a pilot programopens in a new tab or window from the free peer-to-peer therapy platform Koko. The program used the same GPT-3 large language model that powers ChatGPT to generate therapeutic comments for users experiencing psychological distress. Users on the platform who wished to send supportive comments to other users had the option of sending AI-generated comments rather than formulating their own messages. Koko's co-founder Rob Morris reported: "Messages composed by AI (and supervised by humans) were rated significantly higher than those written by humans on their own," and "Response times went down 50%, to well under a minute." However, the experiment was quickly discontinued because "once people learned the messages were co-created by a machine, it didn't work." Koko has made ambiguous and conflicting statements about whether users understood that they were receiving AI-generated therapeutic messages but has consistently reported that there was no formal informed consent processopens in a new tab or window or review by an independent institutional review board.

ChatGPT and Koko's therapeutic messages raise an urgent question for clinicians and clinical researchers: Can large language models be used in standard medical care or should they be restricted to clinical research settings?

In terms of the benefits, ChatGPT and its large language model cousins might offer guidance to clinicians and even participate directly in some forms of healthcare screening and psychotherapeutic treatment, potentially increasing access to specialist expertise, reducing error rates, lowering costs, and improving outcomes for patients. On the other hand, they entail currently unknown and potentially large risks of false information and algorithmic bias. Depending on their configuration, they can also be enormously invasive to their users' privacy. These risks may be especially harmful to vulnerable individuals with medical or psychiatric illness.

As researchers and clinicians begin to explore the potential use of large language model artificial intelligence in healthcare, applying principals of clinical research will be key. As most readers will know, clinical research is work with human participants that is intended primarily to develop generalizable knowledge about health, disease, or its treatment. Determining whether and how artificial intelligence chatbots can safely and effectively participate in clinical care would prima facie appear to fit perfectly within this category of clinical research. Unlike standard medical care, clinical research can involve deviations from the standard of care and additional risks to participants that are not necessary for their treatment but are vital for generating new generalizable knowledge about their illness or treatments. Because of this flexibility, clinical research is subject toopens in a new tab or window additional ethical (and -- for federally funded research -- legal) requirements that do not apply to standard medical care but are necessary to protect research participants from exploitation. In addition to informed consent, clinical research is subject to independent review by knowledgeable individuals not affiliated with the research effort -- usually an institutional review board. Both clinical researchers and independent reviewers are responsible for ensuring the proposed research has a favorable risk-benefit ratio, with potential benefits for society and participants that outweigh the risks to participants, and minimization of risks to participants wherever possible. These informed consent and independent review processes -- while imperfect -- are enormously important to protect the safety of vulnerable patient populations.

There is another newer and evolving category of clinical work known as quality improvement or quality assurance, which uses data-driven methods to improve healthcare delivery. Some tests of artificial intelligence chatbots in clinical care might be considered quality improvement. Should these projects be subjected to informed consent and independent review? The NIH lays out a number of criteria

opens in a new tab or window for determining whether such efforts should be subjected to the added protections of clinical research. Among these, two key questions are whether techniques deviate from standard practice, and whether the test increases the risk to participants. For now, it is clear that use of large language model chatbots is both a deviation from standard practice and introduces novel uncertain risks to participants. It is possible that in the near future, as AI hallucinations and algorithmic bias are reduced and as AI chatbots are more widely adopted, that their use may no longer require the protections of clinical research. At present, informed consent and institutional review remain critical to the safe and ethical use of large language model chatbots in clinical practice.

Benjamin Tolchin, MD, MS,opens in a new tab or window is a neurologist at Yale School of Medicine and the Yale Comprehensive Epilepsy Center, and the inaugural director of the Yale New Haven Health System Center for Clinical Ethics.

https://www.medpagetoday.com/opinion/second-opinions/102987