new research on fibroids

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Promising Trial for a Drug to Ease Uterine Fibroids

About three quarters of women will experience uterine fibroids before they reach the age of 50. With a range of often debilitating symptoms including excessive menstrual bleeding, they are the most common reason women undergo hysterectomies. And there is a lack of effective treatments—most therapies either only mask symptoms or are difficult for patients to tolerate.

Now, researchers have developed a new, more patient-friendly drug that could revolutionize the way clinicians treat some of the most common gynecologic diseases including fibroids and endometriosis. The ObsEva-funded clinical trial published September 17 in the Lancet , which included co-first author Hugh S. Taylor, MD , Anita O’Keeffe Young Professor of Obstetrics, Gynecology & Reproductive Sciences and professor of molecular, cellular, and developmental biology, found that linzagolix (brand name Yselty), an oral drug that hinders estrogen production, is an effective and customizable treatment for fibroids. The treatment not only addresses the symptoms, but also tackles the underlying problem through shrinking the fibroids themselves.

“No treatments to date for fibroid growth are something I would ever want my patients to take for a prolonged period of time, as they did not treat the underlying cause of the problem,” says Taylor. “This is an extremely well tolerated class of drugs that can control fibroid growth. We’ve never had anything like that before.”

Fibroids Can Be Debilitating and Hard to Treat

The impact of uterine fibroids can be devastating. Heavy, prolonged bleeding can significantly disrupt a person’s life—they may need to go through excessive numbers of sanitary pads or tampons, worry about bleeding through and staining clothing, or need to wake up throughout the night to change pads. And profound blood loss may lead to anemia and fatigue. “This can be an impediment to getting a good night’s sleep and being socially active, and it can even affect job performance,” says Taylor.

As fibroids grow larger, they may begin putting pressure on other organs, resulting in a range of unpleasant symptoms including diarrhea or constipation and frequent urination. Fibroids can also lead to difficulty in getting pregnant and increased risk of miscarriage.

Uterine fibroids disproportionately impact Black patients—they are more common and tend to be more aggressive in comparison to white patients.

Most drugs commonly used for uterine fibroids, including birth control pills, fail to treat the fibroids themselves and simply only lighten or stop periods. And more aggressive drugs, although they treat the root of the problem, says Taylor, are “overkill.” For example, leuprolide (brand name Lupron) is an injectable drug that puts patients into a menopausal state by initially overstimulating hormonal receptors, which eventually shuts them down and completely blocks estrogen production. Although the treatment addresses the fibroids, it also can initially exacerbate symptoms and cause harsh side effects. In more extreme cases, patients may choose to undergo a hysterectomy.

Promising Clinical Trial Results

Linzagolix is an oral medication that works similarly to leuprolide by hindering hormone production. However, unlike its predecessor, it works by directly blocking the receptors instead of overstimulating them. The drug is also titratable—clinicians can tailor how much estrogen is blocked in order to best suit an individual patient’s needs without necessarily putting them into a full-blown menopause.

This is an extremely well tolerated class of drugs that can control fibroid growth. We’ve never had anything like that before. Hugh S. Taylor, MD

The new drug may cause menopause symptoms such as hot flashes. Hormonal add-back therapy can be an effective option for mitigating these symptoms. For some patients, however, including patients with obesity, hypertension, or diabetes, this therapy has risks and may not be a suitable option. These conditions also tend to be more prevalent in Black patients. In this group, a lower dose of linzagolix without add-back therapy might be preferable.

To test the effectiveness of the drug, Taylor’s team ran two large prospective, randomized, double-blind, placebo-controlled clinical trials known as PRIMROSE 1 and PRIMROSE 2. The studies enrolled patients suffering from substantial bleeding who were randomly selected to receive a placebo or one of several different doses of the drug—100 mg alone, 100 mg with add-back therapy, 200 mg alone, or 200 mg with add-back therapy. The researchers followed the patients and tracked their symptoms for one year. The researchers considered the therapy successful if the patient’s bleeding was reduced by half and also stayed in what is considered the normal range.

Patients in all four treatment groups experienced a significant reduction in menstrual bleeding. The 200 mg with add-back therapy group worked with “amazing efficacy,” says Taylor—the clinical trials showed a 75.5 percent response rate in PRIMROSE 1 and a 93.9 response rate in PRIMROSE 2. Even the lower dose of the drug still showed promising results. There were greater than 60% response rates in both trials for the 100 mg group with add-back therapy, and the 100 mg group without add-back showed better than 50% response rates.

“What is interesting and unique about our trials, that has not been done with other drugs in this class, is that we used a low dose with or without hormones,” says Taylor. “This is a great option for patients who experience severe menopause symptoms from the high dose or have a medical problem where they can’t tolerate hormonal add-back therapy.”

Revolutionizing Treatment of Gynecologic Diseases

Linzagolix is one of several in this new class of drugs in development for the treatment for common gynecologic diseases. Taylor was also involved in the 2017 clinical trial for elagolix , (brand name Orlissa), a medication designed to suppress endometriosis that has recently become available for patients.

Linzagolix has been approved in Europe, but is not yet available in the United States. Taylor says drugs in this class will radically change how clinicians treat fibroids, and he hopes linzagolix will lead to a reduction in future hysterectomies once it becomes available.

“A good medical therapy is finally here for fibroids, and I predict that what was a very common operation will dramatically decrease within the next few years,” he says. “Reducing the need for hysterectomy is very important for patients who don’t want to undergo a major surgery, especially for younger people who may still want to preserve the potential of having children in the future.”

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• Hugh Taylor, MD Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology; Chair, Obstetrics, Gynecology & Reproductive Sciences; Chief , Obstetrics and Gynecology, Yale New Haven Hospital

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August 14, 2023

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Scientists develop new model for understanding uterine fibroids

by Olivia Dimmer, Northwestern University

Northwestern Medicine scientists have developed a new cellular model of uterine fibroids that stem from common genetic mutations, which will accelerate further research and development of future treatments, according to findings published in Nature Communications .

It's estimated that more than half of all women will develop uterine fibroids—noncancerous muscular tumors that grow in the wall of the uterus—at some point in their lives, according to the American College of Obstetricians and Gynecologists.

It's not clear what causes uterine fibroids to develop, but many scientists believe hormonal and genetic factors play a role.

Nearly 70% of uterine fibroids are linked to a mutation in the MED12 gene, but research has been stymied by a lack of tractable cellular models to study, said Mazhar Adli, Ph.D., associate professor of Obstetrics and Gynecology in the Division of Reproductive Science in Medicine and senior author of the study.

"When cultured in the lab, the mutant cells in the fibroid tumor do not survive and hence the cellular model that mimics fibroid tumors could not be generated," said Adli, who is also a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

To address this challenge, his lab used CRISPR-based genome editing technology to precisely engineer cells that have the same mutation in the MED12 gene.

"We found that these engineered mutant cells, like fibroid tumor cells, did not proliferate well in a 2D culture, however when we culture them in 3D conditions, that better mimics the normal in vivo physiology, and they proliferated better," Adli said.

After successfully culturing the mutated fibroid cells in 3D spheres, Adli and his collaborators noticed that the cells produced heightened levels of collagen, a key feature of uterine fibroids, as well as other chromosomal abnormalities commonly seen in uterine fibroids in patients.

"Having an accurate cellular model of uterine fibroid growth will aid in future research around fibroid treatment," Adli said.

"This model opens the door for us to conduct subsequent studies to try to identify drugs that will selectively target these mutant fibroid cells," Adli said. "We could not do these experiments before because we didn't have a model system . Now that we do, we are able to conduct high-throughput CRISPR screenings to identify potential therapeutic targets."

In addition to follow-up studies into potential treatment targets for uterine fibroids , Adli's cell models will be available to other scientists and will hopefully expedite further research into the condition.

"So far, the basic biology of this disease has been lacking," Adli said. "Either there were not enough resources or there was not a good model system really to understand the molecular biology and genomic features of this disease. I think this model system and additional model systems that we are generating will really help us to understand the disease in a much better, more tractable way."

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U.S. News: New insights into fibroids might lead to better treatments

Uc researchers reveal ways fibroids respond to strain compared to uterine cells.

U.S. News & World Report highlighted the University of Cincinnati's research into new avenues to treat fibroids, a painful condition that affects 8 in 10 women during their lifetimes.

Researchers in UC's College of Medicine and College of Engineering and Applied Science found different signaling pathways being used by the fibroid cells compared to the uterine cells.

“That’s important for identifying therapeutic targets because we want to target the tumor without affecting the surrounding tissue,” said Stacey Schutte, an assistant professor of biomedical engineering in UC’s College of Engineering and Applied Science.

The study was published in  the journal F&S Science .

In their study, fibroid cells and uterine cells were grown in the lab on plates with an elastic bottom. Researchers then used a vacuum to pull and stretch the cells, mimicking the uterine environment. They saw differences in the way cells held their shape.

"We found that fibroid cells were more sensitive to strain," said lead author  Dr. Rachel Warwar , from the University of Cincinnati's College of Medicine. She said the findings underscore the importance of incorporating mechanical strain, and not just hormones, into the study of fibroid cells.

"The more we are able to mimic the environment of these cells in the uterus, the more we will understand the pathology of these cells and then can work to target anomalous pathways in fibroid cells," Warwar added.

Read the U.S. News & World Report story.

Featured image at top: UC Research Associate Andreja Moset Zupan, left, and Assistant Professor Stacey Schutte study new avenues to treat fibroids in Schutte's biomedical engineering lab. Photo/Andrew Higley/UC Marketing + Brand

UC Research Associate Andreja Moset Zupan, left, and Assistant Professor Stacey Schutte study new avenues to treat fibroids in Schutte's biomedical engineering lab. Photo/Andrew Higley/UC Marketing + Brand

• In The News
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News Center

New genes implicated in uterine fibroid development.

Northwestern Medicine scientists have identified new genes implicated in the development of uterine fibroids, according to a study published in Nature Communications .

Uterine fibroids, a type of non-cancerous growth in the uterus, are very common: around 70 percent of women will develop a uterine fibroid in their lifetime, according to the U.S. Department of Health and Human Services Office on Women’s Health. For most women, uterine fibroids are harmless, but nearly a quarter of those afflicted will suffer from excessive uterine bleeding, anemia and recurrent pregnancy loss.

Despite their prevalence, uterine fibroids are notoriously understudied, said Mazhar Adli, PhD , the Thomas J. Watkins Memorial Professor of Tumor Genomics, associate professor of Obstetrics and Gynecology in the Division of Reproductive Science in Medicine and senior author of the study.

“Uterine fibroids are not well-studied, at least not compared to other tumors,” Adli said.

In the current study, Northwestern Medicine investigators performed a meta-analysis of existing fibroid genome-wide association studies representing more than 20,000 uterine fibroid cases. They identified 24 new risk loci, or locations on the human genome, where genetic variants increased the risk of developing uterine fibroids.

The investigators then integrated that information with single-cell gene expression data from uterine fibroid patients and identified causal cell types with increased expression of those high-risk genes. It was previously understood that smooth muscle cells contribute to uterine fibroids, but Adli and his collaborators found that certain immune cells also play a role, he said.

Previously, around 120 genes were thought to contribute to the risk of developing uterine fibroids. However, by integrating the 3D genomic organization data and epigenomic data, Adli’s group has shown that nearly 400 genes may contribute to fibroid development. To experimentally validate which of these genes are related to disease risk, the scientists used CRISPR-based epigenetic repression or activation of fibroid disease-associated genomic regions to narrow down and validate disease-associated genes.  

“One of the significances of the study is to understand which population may be at a higher risk for uterine fibroids, but more critically, what are the potential genes that are being affected by this variance that are causing uterine fibroids,” Adli said.

The study also incorporated data from people with diverse ancestries, yielding a more inclusive picture of uterine fibroid risk compared to previous studies which only analyzed patients of European ancestry, Adli said.

“Historically, a lot of these studies have been done in European ancestry populations,” said Adli, who is also a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. “When we took that information and compared it to a majority Black population, or Japanese population, the regions of the genome associated with disease are unique. That really shows the importance of studying diseases in diverse ancestry populations.” 

Now, Adli and his collaborators will build off this discovery and inhibit the identified genes in models of the disease to see if uterine fibroid growth can be halted, he said.

“The next step for us is to further understand the genetics of this disease to find which genes should we inhibit to block the development of uterine fibroids,” Adli said.

The study was supported in part by a pilot award from the Northwestern Uterine Leiomyoma Research Center.

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FDA Approves Myfembree to Treat Uterine Fibroids

Myovant Sciences

Key Takeaways

• Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus .
• Myovant Sciences and Pfizer launch Myfembree, the only once-daily treatment available for people with fibroids.
• Myfembree was approved by the FDA on May 26, 2021, and is currently available in the United States.

On May 26, 2021, the Food and Drug Administration (FDA) approved Myfembree as the first once-daily treatment for heavy menstrual bleeding that is associated with uterine fibroids .

As of June 17, 2021, the medication is available to patients in the U.S. with a physician's referral.

Uterine fibroids do not always cause symptoms. When they do, the heavy bleeding and pelvic pain that they can cause can greatly affect a person's quality of life. Experts say that Myfembree could be life-changing for people who have had only limited and invasive options for treatment.

An estimated 26 million women between the ages of 15 and 50 have uterine fibroids.

A Game Changer

In July 2013, Tanika Gray Valbrun , the founder of The White Dress Project, experienced heavy bleeding and pain. When she went to her doctor, they discovered that she had 27 uterine fibroids (noncancerous tumors that develop in the walls of the uterus).

The tumors were wreaking havoc on her body, so Valbrun had to have a myomectomy to surgically remove the fibroids from her uterus.

“It was the first time I was ever having surgery at all and the recovery was horrible,” Valbrun tells Verywell. “I had all 27 fibroids removed.”

After experiencing such an invasive and complex procedure, Valbrun says that a treatment like Myfembree could be a game-changer.

“I’m really happy about the introduction of this drug and the fact that women have options, because a lot of times with uterine fibroids, we haven’t been given options to manage the symptoms,” says Valbrun. “Symptoms are really what has the greatest impact on your quality of life.” 

How Myfembree Could Help

Myfembree is a pill that contains a gonadotropin-releasing hormone antagonist ( relugolix ), estradiol (E2), and norethindrone acetate (NETA), which work together to help stop heavy menstrual bleeding.

Tanika Gray Valbrun

Symptoms are really what has the greatest impact on your quality of life.

In Myovant Sciences' studies on the effectiveness of Myfembree, they assessed the response rate in the women included in the study.

The response was defined as a menstrual blood loss volume of fewer than 80 milliliters and a 50% reduction in menstrual blood loss volume during the last 35 days of treatment.

In the studies, Myfembree demonstrated 72.1% and 71.2% response rates in menstrual blood loss at the 24th-week mark compared to 16.8% and 14.7% of women in the placebo group.

The women who received Myfembree experienced reductions in menstrual blood loss of 82% and 84.3%.

Why New Treatments Are Needed

It is estimated that three million women are inadequately treated by current medical interventions for uterine fibroids .

Ayman Al-Hendy, MD, PhD

Many women are suffering in silence due to the social stigma that surrounds menstruation and talking about periods.

Ayman Al-Hendy, MD, PhD , professor in the Department of Obstetrics and Gynecology at the University of Chicago and clinical scientist and practicing OB/GYN, tells Verywell that Myfembree would allow people with fibroids who have not had success with current treatments to better manage their fibroids and overall health.

“Many women are suffering in silence due to the social stigma that surrounds menstruation and talking about periods or thinking that major surgery is the only treatment option,” says Al-Hendy. 

Uterine fibroids account for over 250,000 hysterectomies each year. After discovering how many fibroids she had, Valbrun's doctors considered her uterus to be compromised and suggested a hysterectomy .

“I felt very devastated, " says Valbrun. "It’s not what you want to hear, especially when you think of doing life the way you’re supposed to do it, go to school, get a good job, then get married and have babies."

Al-Hendy says that while treatments have been available for fibroids, they have been invasive with little to no non-invasive treatment options available and that the approval of a once-daily pill "represents a significant milestone in expanding treatment options for this burdensome condition."

Raising Awareness 

Valbrun thought she was the only one experiencing heavy bleeding, and she says that she found herself asking, "How many women who I know are secretly dealing with this?”

With a mission to raise awareness of fibroids, Valbrun started a nonprofit organization called The White Dress Project , which is based in Atlanta, Georgia. The organization’s mission is to raise global awareness about uterine fibroids through education, research, community, and advocacy.

Valbrun hopes that The White Dress Project will catalyze conversations about fibroids and empower people with fibroids to advocate for the treatment that works best for them. She says that the organization is "intentional about making sure that women know they have to be their own best health advocate."

Myfembree is available as of June 17, but Valbrun encourages people with fibroids to talk to their doctors and bring up any questions they have about treatment options to ensure that they get the treatment that will work best for them.

Al-Hendy adds that “Myfembree has the potential to provide much-needed symptom relief with the convenience of an oral, once-daily tablet," and that "it’s an important step forward in a disease area that has historically relied heavily on invasive procedures.” 

What This Means For You

If you have uterine fibroids or experiencing heavy bleeding that you are concerned could be caused by fibroids, talk to your doctor about your treatment options. You might be able to get a referral for a new once-daily treatment, Myfembree, which was just approved by the FDA.

Pfizer. Myovant Sciences and Pfizer receive FDA approval for Myfembree, the first once-daily treatment for heavy menstrual bleeding associated with uterine fibroids .

Agency for Healthcare Research and Quality. Management of uterine fibroids .

Myovant Sciences. Myfembree: highlights of prescribing information .

By Kayla Hui, MPH Hui is a health writer with a master's degree in public health. In 2020, she won a Pulitzer Center Fellowship to report on the mental health of Chinese immigrant truck drivers.

New research reveals important discovery for women who have fibroids

• 30 July 2020

New research findings will help women and doctors make an informed decision about treatment of uterine fibroids.

The NIHR-funded FEMME trial led by a collaborative group of researchers at the University of Oxford, St George’s Hospital London, and the Universities of Birmingham and Glasgow, compared two competing treatments which allow fertility for symptomatic uterine fibroids, to see which option best reduced symptoms and improved the patient’s quality of life.

The results from the trial, which published in the  New England Journal of Medicine , showed that myomectomy, a surgical procedure performed to remove uterine fibroids, resulted in a small but significantly higher quality of life compared with uterine artery embolisation (UAE). UAE is a minimally invasive procedure which shrinks the fibroids by placing tiny beads into the blood vessels which supply them.

A fibroid is a non-cancerous growth of the womb, with 1 in 3 women developing them at some point in their life. They most often occur in women aged 30-50 and develop more frequently in women of African-Caribbean family origin. Approximately half of women with uterine fibroids experience significant symptoms that can include heavy menstrual bleeding, abdominal pain and bloating.

Fibroids may also be associated with infertility and problems during pregnancy, including miscarriage and preterm birth. As more women are having children at a later age, fibroids are becoming more of an issue for them and safe and effective fertility sparing treatments are needed.

Two hundred and fifty-four eligible women, wishing to reduce fibroid symptoms were recruited from over 29 UK hospitals to participate in the trial. Researchers compared the two fertility preserving treatments for uterine fibroids on two patient groups. The first patient group comprised of women with an intention to conceive whilst the second group was made up of black women (who have a particularly high incidence of uterine fibroids).

The women were randomised to receive either a myomectomy or UAE procedure. The trial revealed that contrary to popular belief, rates of conception were shown to be broadly similar between the myomectomy and UAE group. Although too few trial participants were trying to get pregnant to be able to determine with certainty whether there was an impact of either treatment on pregnancy rates, which was higher in the UAE group.

Klim McPherson, Visiting Professor of Public Health Epidemiology at Oxford University and study Chief Investigator, said: “These findings are important and reveal new evidence for our understanding of the best treatment for women with fibroids who wish to avoid a hysterectomy. 

“It is worth noting that the myomectomy group reported only marginally higher quality of life score than the Uterine Artery Embolisation group, although on average women in both groups saw improvements. Interestingly, the perceived drawback associated with embolisation, that it might affect the working of the ovaries, was not supported by the evidence in this trial.”

Professor Andy Shennan, Professor of Obstetrics, and Clinical Director NIHR Clinical Research Network South London, said, “This work is a major contribution to knowledge on the management of the most common tumour in women of reproductive age. The researchers found a significant but small advantage for myomectomy in terms of quality of life, while observing slightly more pregnancies in the UAE arm, which provides wider treatment choices for women with symptomatic fibroids.”

The study was funded by the NIHR Health Technology Assessment Programme

More information about the study is available on the NIHR’s Funding & Awards website

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Uterine fibroid growth activated by chemicals found in everyday products

• Feinberg School of Medicine
• Women’s Health

For the first time, scientists at Northwestern Medicine have demonstrated a causal link between environmental phthalates (toxic chemicals found in everyday consumer products) and the increased growth of uterine fibroids, the most common tumors among women.

Manufacturers use environmental phthalates in numerous industrial and consumer products, and they’ve also been detected in medical supplies and food. Although they are known to be toxic , they are currently unbanned in the U.S.

“These toxic pollutants are everywhere, including food packaging, hair and makeup products, and more, and their usage is not banned,” said corresponding study author Dr. Serdar Bulun , chair of the department of obstetrics and gynecology at Northwestern University Feinberg School of Medicine and a Northwestern Medicine physician. “These are more than simply environmental pollutants. They can cause specific harm to human tissues.”

80% Up to 80% of all women may develop a fibroid tumor during their lifetime.

Up to 80% of all women may develop a fibroid tumor during their lifetime, Bulun said. One-quarter of these women become symptomatic with excessive and uncontrolled uterine bleeding, anemia, miscarriages, infertility and large abdominal tumors necessitating technically difficult surgeries.

The new study found women with a high exposure to certain phthalates such as DEHP (used as a plasticizer to increase the durability of products such as shower curtains, car upholstery, lunchboxes, shoes and more) and its metabolites have a high risk for having a symptomatic fibroid.

The study was published Nov. 14 in the Proceedings of the National Academy of Sciences (PNAS). 

Prior epidemiological studies have consistently indicated an association between phthalate exposure and uterine fibroid growth, but this study explains the mechanisms behind that link. The scientists discovered exposure to DEHP may activate a hormonal pathway that activates an environmentally responsive receptor (AHR) to bind to DNA and cause increased growth of fibroid tumors.

“Interestingly, AHR was cloned in the early ’90s as the receptor for dioxin, the key toxin in the agent orange,” said Bulun, who also is  a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University . “The use of agent orange during the Vietnam war caused significant reproductive abnormalities in the exposed populations; and dioxin and AHR were thought to be responsible for this.”

This new study, Bulun said, provides further evidence to support these theories.

DEHP has been the most widely used phthalate. Although there has been increased concern in the public and some regulatory restrictions in European Union countries, it is still widely used for the packaging of food and health products in the U.S. and across the world. DEHP can be gradually released from consumer products into indoor environments such as homes, schools, daycare centers, offices and cars. It settles on floors and other surfaces and can accumulate in dust and air. During pregnancy, DEHP can pass from mother to baby.

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The Future of Uterine Fibroid Management: A More Preventive and Personalized Paradigm

Malak el sabeh.

* Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA

Mostafa Borahay

Uterine fibroids are the most common tumors of the female reproductive tract, affecting up to 80% of women. Despite their heavy burden and high prevalence, available medical treatment options are limited and are offered to patients assuming equal responsiveness. These benign tumors are complex, originating from potentially diverse pathobiologic processes, yet they are all managed in a rather standardized symptom-oriented approach that does not take into account the underlying processes. With our increasing understanding of the interplay between genes, epigenetics, individual’s lifestyle and the environment in disease development, uterine fibroids management should be geared towards individualized preventive and treatment options. For example, it seems that some subsets of patients with fibroids also suffer from vitamin D deficiency, hypertension, metabolic syndrome or other conditions. It is possible that these subsets may have different underlying processes and different responsiveness to different treatment options. Herein, we call for a futuristic paradigm shift of research to develop a new model to manage uterine fibroids with the treatment approach varying depending on the patient’s perceived underlying processes as assessed by medical, social, family history and relevant investigations. This is only possible through the collaboration of scientists, physicians, and funding agencies and with the help of our patients.

Problems can be simple, complicated, or complex. Uterine fibroids are squarely in the complex category. This applies to why they develop and how they present. For example, how many times do we incidentally discover large fibroids barely causing any symptoms while a much smaller tumor in a similar location may cause significant symptoms in another patient? Why do some fibroids grow at a fast clip while others stay stationary over several years? Why do fibroids recur in some women while in others they do not? Are we adopting a “one size fits all” approach that ignores the disease variability and heterogeneity?

With our increasing understanding of the interplay between genes, epigenetics, individual’s lifestyle, and the environment in disease development, precision medicine geared towards individualized prevention and treatment options is expanding, and uterine fibroids should be no exception. Uterine fibroids are the most common tumors of the female reproductive tract, affecting up to 80% of women. Yet, available medical treatment options are not only limited, but they are offered assuming equal responsiveness. To reduce the health, economic, social, and psychological burden of these tumors, a better understanding of different pathogenic pathways is necessary to enable effective prevention and management approaches. It is time to utilize the information we currently know on risk factors and treatment options and use it to manage this benign tumor.

A striking example is the association of low vitamin D with uterine fibroids. Robust evidence suggests that a rigorous clinical trial is not only indicated, but overdue [ 1 , 2 ]. Another example is the association of cardiometabolic risk factors; including obesity, hypertension, hyperlipidemia, and metabolic syndrome with uterine fibroid development [ 3 ]. While more studies are needed to identify the mechanisms of this association, it offers the potential for clinical intervention through lifestyle changes and medications. Our group showed the possible beneficial effects of simvastatin, an anti-hyperlipidemic drug, on uterine fibroids through in vitro, in vivo, and epidemiologic studies [ 4 – 7 ]. Simvastatin was shown to induce calcium dependent apoptosis [ 5 ], reduce extracellular matrix deposition [ 8 ], and restore the altered mechanotransduction state in uterine fibroids [ 4 ]. A nested-case control study showed that statin use was also associated with a lower risk of uterine fibroid development and experiencing fibroid-related symptoms [ 7 ]. Similarly, a recent study suggests that angiotensin-converting enzyme inhibitors may reduce uterine fibroid incidence in hypertensive patients [ 9 ]. It seems reasonable to think that the underlying pathobiologic processes and the response to treatment options can be different between patients with vitamin D deficiency and those with hypertension/metabolic syndrome.

One of the possible limitations to the development of effective therapeutics for uterine fibroids is the assumption that it is one uniform disease. As mentioned earlier, fibroids behave differently in their growth rate and the symptoms they produce. It is also possible that fibroids are the ultimate presentation of a group of different pathogenic pathways. For example, the observed cellular proliferation and the deposition of excessive extracellular matrix can be the outcome of different disease processes such as cardiometabolic risk factors, hypertension, or low vitamin D levels. One or more of these processes can be predominant in a group of patients. Therefore, it is conceivable that some patients may respond to vitamin D, while others may respond to simvastatin, angiotensin-converting enzyme inhibitors and so on. Thus, it can be helpful to identify the specific disease processes in each patient to deploy its appropriate treatment ( Fig. 1 ).

A potential stratification paradigm according to the pathobiology patients might have.

To efficiently prevent the development of uterine fibroids, it would be wise to target the group of women who are at highest risk. More research is needed to develop sensitive and specific biomarkers that can accurately predict future fibroid growth and symptom development beyond the initial work we currently have [ 10 ]. These biomarkers should be non-invasive and cost-effective manner for efficient application. The future of uterine fibroid prevention can be developing a reliable risk calculator using these biomarkers and individual risk factors, such as age, race, parity, family history, lifestyle, medication use including hormonal contraception. This would be similar to the extensively used ASCVD (atherosclerotic vascular disease) risk calculator which uses several factors such as age, gender, and cholesterol level to predict cardiovascular events and guide primary prevention management [ 11 ]. Similarly, the uterine fibroid risk calculator would serve as a tool to direct management, where a determined cut-off would prompt the use of established preventive medications ( Fig. 2 ). Certainly, more research is needed to develop this risk score calculator and to validate its effectiveness in predicting uterine fibroids, their symptomatology, and responsiveness to management options.

Potential fibroid risk calculator for consideration by future research. The aim of this calculator would be to guide prevention after stratifying the patients depending on their risk factors.

Despite its high burden, uterine fibroids’ research funding is considerably low, a problem hindering women health research in general. Recently, several women health professional organizations formed a coalition to advocate for increasing funding to propel women health research and discovery [ 12 ]. The therapeutic examples discussed in this article are already available drugs with decades of clinical use, established safety and low cost. While drug repurposing is a highly efficient approach to hasten discovery, these very advantages, in fact, discourage pharmaceutical companies as these drugs are already generic. This highlights the critical role of NIH for funding clinical trials and mechanistic studies of these drugs. This is in no way a call to stop developing and examining new molecules, but rather to broaden our search. The currently ongoing clinical trial ( NCT03400826 ) for simvastatin in women with uterine fibroids funded by the Gynecologic Health and Disease Branch (GHDB) of the National Institute of Child Health and Human Development (NICHD) is an example of such highly needed studies.

In summary, this is a call for a new paradigm in uterine fibroid research focused in a more precise approach. Undoubtedly, more clinical, epidemiologic and translational research is needed to further develop these prevention and individualized treatment options. This is only possible through the cooperation of scientists, physicians, funding agencies, and patients. It is critical to prioritize uterine fibroid prevention and management research in an effort to reduce the heavy burden of women suffering from this condition and the billions of dollars spent to manage it.

This work was supported, in part, by NIH grant 1R01HD094380 to Mostafa Borahay.

Conflict of interest

On behalf of all authors, the corresponding author states that there is no conflict of interest.

• Introduction
• Conclusions
• Article Information

eAppendix. Assay Details for Cardiovascular Biomarkers

eReferences

eFigure 1. Study Timeline and Schematic

eFigure 2. Directed Acyclic Graph (DAG) Showing the Relationships Between Each Confounder, the Exposure (in This Example, Blood Pressure) and the Outcome (Self-Reported Fibroid Diagnosis)

eTable 3. Longitudinal Discrete Survival Models Estimate the Risk of Newly Diagnosed Fibroids Associated With Each Cardiovascular Risk Factor in the Study of Women’s Health Across the Nation (SWAN) Cohort

eTable 4. Longitudinal Discrete Survival Models Estimate the Risk of Newly Diagnosed Fibroids Associated With Each Cardiovascular Risk Factor in the Study of Women’s Health Across the Nation (SWAN) Cohort

eTable 5. Longitudinal Discrete Survival Models Estimate the Risk of Newly Diagnosed Fibroids Associated With Each Cardiovascular Risk Factor in the Study of Women’s Health Across the Nation (SWAN) Cohort

eTable 6. Longitudinal Discrete Survival Models Estimate the Risk of Newly Diagnosed Fibroids Associated With Each Cardiovascular Risk Factor in the Study of Women’s Health Across the Nation (SWAN) Cohort

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Mitro SD , Wise LA , Waetjen LE, et al. Hypertension, Cardiovascular Risk Factors, and Uterine Fibroid Diagnosis in Midlife. JAMA Netw Open. 2024;7(4):e246832. doi:10.1001/jamanetworkopen.2024.6832

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Hypertension, Cardiovascular Risk Factors, and Uterine Fibroid Diagnosis in Midlife

• 1 Division of Research, Kaiser Permanente Northern California, Oakland
• 2 Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts
• 3 Department of Obstetrics and Gynecology, University of California Davis School of Medicine, Davis
• 4 Department of Obstetrics and Gynecology, Kaiser Permanente Northern California, Oakland
• 5 Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor
• 6 Brigham and Women’s Hospital, Boston, Massachusetts
• 7 Department of Psychology and Psychiatry, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
• 8 Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
• 9 Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora

Question   Are study-measured blood pressure, antihypertensive treatment, and cardiovascular risk factors (anthropometry and biomarkers) associated with incidence of fibroids?

Findings   In this cohort study of 2570 individuals at midlife, participants with untreated and new-onset hypertension had increased risk of newly self-reported fibroids, whereas those taking antihypertensive treatment had lower risk. Anthropometric factors and blood biomarkers were not associated with risk of newly reported fibroids.

Meaning   These findings motivate investigation into the mechanisms underlying fibroids and may lead to new strategies for their prevention.

Importance   Fibroids are benign neoplasms associated with severe gynecologic morbidity. There are no strategies to prevent fibroid development.

Objective   To examine associations of hypertension, antihypertensive treatment, anthropometry, and blood biomarkers with incidence of reported fibroid diagnosis in midlife.

Design, Setting, and Participants   The Study of Women’s Health Across the Nation is a prospective, multisite cohort study in the US. Participants were followed-up from enrollment (1996-1997) through 13 semiannual visits (1998-2013). Participants had a menstrual period in the last 3 months, were not pregnant or lactating, were aged 42 to 52 years, were not using hormones, and had a uterus and at least 1 ovary. Participants with prior fibroid diagnoses were excluded. Data analysis was performed from November 2022 to February 2024.

Exposures   Blood pressure, anthropometry, biomarkers (cholesterol, triglycerides, and C-reactive protein), and self-reported antihypertensive treatment at baseline and follow-up visits were measured. Hypertension status (new-onset, preexisting, or never [reference]) and hypertension treatment (untreated, treated, or no hypertension [reference]) were categorized.

Main Outcomes and Measures   Participants reported fibroid diagnosis at each visit. Discrete-time survival models estimated hazard ratios (HRs) and 95% CIs for associations of time-varying hypertension status, antihypertensive treatment, anthropometry, and biomarkers with incident reported fibroid diagnoses.

Results   Among 2570 participants without a history of diagnosed fibroids (median [IQR] age at screening, 45 [43-48] years; 1079 [42.1%] college educated), 526 (20%) reported a new fibroid diagnosis during follow-up. Risk varied by category of hypertension treatment: compared with those with no hypertension, participants with untreated hypertension had a 19% greater risk of newly diagnosed fibroids (HR, 1.19; 95% CI, 0.91-1.57), whereas those with treated hypertension had a 20% lower risk (HR, 0.80; 95% CI, 0.56-1.15). Among eligible participants with hypertension, those taking antihypertensive treatment had a 37% lower risk of newly diagnosed fibroids (HR, 0.63; 95% CI, 0.38-1.05). Risk also varied by hypertension status: compared with never-hypertensive participants, participants with new-onset hypertension had 45% greater risk of newly diagnosed fibroids (HR, 1.45; 95% CI, 0.96-2.20). Anthropometric factors and blood biomarkers were not associated with fibroid risk.

Conclusions and Relevance   Participants with untreated and new-onset hypertension had increased risk of newly diagnosed fibroids, whereas those taking antihypertensive treatment had lower risk, suggesting that blood pressure control may provide new strategies for fibroid prevention.

Uterine fibroids are benign, hormonally responsive tumors that occur in 70% to 80% of people with uteruses by age 50 years, approximately one-half of whom have clinically relevant disease. 1 A high-risk time for fibroid diagnosis begins around age 40 years. 2 Although fibroids are common and cause debilitating symptoms, including pain and bleeding, 3 no strategies are available to prevent them.

Growing evidence suggests that hypertension and other cardiovascular risk factors (including cholesterol levels, anthropometric measurements, carotid intima-media thickness, ankle-brachial index, and body composition) may be associated with fibroids. 4 However, most studies have been cross-sectional, 5 - 13 precluding analysis of temporality. Evidence from prospective studies is limited. One study 14 reported a positive association between diastolic blood pressure and risk of fibroid diagnosis, whereas another 15 reported that hypertension, but not heart attack or stroke, was associated with greater risk of fibroid surgery. A third study 16 linked untreated hypertension with ultrasonography-confirmed fibroids only and treated hypertension with risk of hysterectomy-confirmed fibroids only. These prior prospective studies used self-reported blood pressure, hypertension diagnosis, and antihypertensive use and, thus, may be subject to reporting errors. If blood pressure affects fibroid risk, hypertension control may have the added benefit of preventing fibroid development or growth.

Prospective longitudinal studies with criterion-standard risk factor ascertainment are needed to elucidate potential associations between hypertension, markers of cardiovascular risk, and fibroids. Using data from a racially and ethnically diverse prospective cohort, Study of Women’s Health Across the Nation (SWAN), we examined whether measured hypertension, antihypertensive treatment, and other cardiovascular risk factors were associated with new fibroid diagnosis in midlife, when fibroids often become clinically apparent.

SWAN is a multisite cohort study that enrolled 3302 participants between 1996 and 1997. 17 Eligible participants had a menstrual period in the 3 months before enrollment, were not pregnant or lactating, were aged 42 to 52 years, were not using hormones, and had a uterus and at least 1 ovary. Recruitment details have been published elsewhere. 18 Protocols were approved by institutional review boards at each participating institution. Participants provided written informed consent at each study visit. This manuscript follows Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) reporting guideline for observational studies.

Fibroid diagnosis was reported at baseline (visit 0, 1996-1997) and longitudinally through visit 13 (2011-2013, at which point nearly all participants were postmenopausal). Follow-up visits occurred approximately once per year from 1998 to 2008 (visits 1-11); visit 12 was in 2010 to 2011. At baseline participants were asked, “Has a doctor, nurse practitioner or other health care provider ever told you that you had fibroids, benign growths of the uterus or womb?” In visits 1 to 13, participants were asked, “Since your last study visit, have you had fibroids (benign growths in the uterus or womb)?” Self-reported fibroid diagnosis has been shown to have high specificity. 19 We excluded participants who reported a history of fibroids at enrollment (670 participants [20.3%]) or were missing baseline fibroid status (62 participants [1.9%]). eTable 1 in Supplement 1 compares participants with and without fibroids at baseline. eFigure 1 in Supplement 1 shows a timeline and sample sizes for each visit.

At each visit, study staff measured blood pressure with a standardized protocol: 2 readings from the right arm after the participant had been seated for 5 minutes. We averaged the measured values. We defined hypertension as study-measured systolic blood pressure 130 mm Hg or higher or diastolic blood pressure 80 mm Hg or higher. 20 Study staff also measured participant waist and hip circumference, height, and weight, and calculated waist-to-hip ratio and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared).

We quantified high-sensitivity C-reactive protein (hsCRP), total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides in fasting blood samples (plasma or serum). hsCRP was quantified at baseline and visits 1, visits 3 to 7, and visits 9 to 12. Lipids were quantified at baseline and visits 1, 2 to 7, 9, 12, and 13. The study laboratory changed between visits 7 and 9, so concentrations were calibrated to ensure consistency. Additional details of the assays and calibration procedures are in the eAppendix in Supplement 1 .

We created a 3-category hypertension treatment variable to evaluate associations of fibroid diagnosis risk with treated and untreated hypertension. The hypertension treatment variable was updated at each visit and compared (1) participants with no antihypertensive treatment and measured normotension (no hypertension [reference group]) with (2) participants with no antihypertensive treatment and measured hypertension (untreated hypertension) and (3) participants receiving antihypertensive treatment regardless of measured blood pressure (treated hypertension).

We also created a 3-category, time-varying hypertension status variable to capture associations of fibroid diagnosis risk with hypertension onset. The hypertension status variable used information from current and prior visits and compared (1) participants who had never reported antihypertensive use and never had measured hypertension (ie, systolic blood pressure ≥130 mm Hg and diastolic blood pressure ≥80 mm Hg) (never hypertensive [reference group]) with (2) participants who had reported antihypertensive treatment or had measured hypertension at past visits (preexisting hypertension) and (3) participants who reported antihypertensive treatment or had measured hypertension for the first time at the current visit (new-onset hypertension).

Participants reported all medication used at each visit, and study staff categorized each medication by mechanism. Antihypertensive medications included α-blockers, β-blockers, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, and diuretics. Participants who reported use of antihypertensive medication in the current visit or in a prior visit were considered to be using antihypertensive medication; however, the type of antihypertensive medication used was updated at each visit and reflected current use only.

Models of time-varying antihypertensive treatment vs no treatment were conducted among a subpopulation of participants eligible to be treated with antihypertensives (624 participants at baseline; using antihypertensive medication; having systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg; or having systolic blood pressure ≥130 or diastolic blood pressure ≥80 mm Hg and at least 1 risk factor [age ≥65 years, history of cardiovascular event, 10-year atherosclerotic cardiovascular disease risk score ≥10%, 21 or diabetes]) (eFigure 1 in Supplement 1 ). 20 We also evaluated time-varying treatment with ACE inhibitors specifically, because of evidence suggesting that ACE inhibitors may be associated with lower fibroid incidence 22 (ACE inhibitors were 28%-34% of antihypertensive medications used across visits). eTable 2 in Supplement 1 describes the subpopulation eligible for antihypertensive treatment.

Participants self-reported their age, educational attainment, race and ethnicity, smoking status, and parity. To identify race and ethnicity, participants were asked their primary group and told to choose 1 group if identifying as multiple races and ethnicities. Data on race and ethnicity are included in this analysis because Black women experience elevated risk of both fibroids and hypertension compared with White women. 23 , 24

Because fibroids are diagnosed by radiological tests or physical examinations, they are more likely to be identified in participants with greater health care engagement. We operationalized health care utilization with variables that may reflect healthy behaviors, health care seeking, and health care access, 25 such as multivitamin use, calcium supplementation, annual times spoken to a health care practitioner, and recency of last mammogram. To explore the role of gynecologic symptoms and care on likelihood of fibroid detection, we used recency of last pelvic examination, abnormal bleeding, and pelvic pain. We categorized menopausal status using data on menstrual bleeding patterns, pregnancy and/or breastfeeding, hormone use, and hysterectomy and/or oophorectomy. 26 All variables except baseline age, education, site, and race and ethnicity were updated at each visit.

Data analysis was performed from November 2022 to February 2024. We used discrete-time survival models (with a complementary log-log link) to estimate hazard ratios (HRs) and 95% CIs for the associations of hypertension, anthropometry, blood biomarkers, and new reported fibroid diagnosis. 27 We censored participants at menopause (because it is unusual for fibroids to develop after menopause), 28 hysterectomy, loss to follow-up, or visit 13 (last visit with fibroid data), whichever occurred first. One site paused data collection for several years after visit 5, so we censored participants from that site at the pause. When participants had missing data due to a missed visit or questionnaire changes, we imputed the last observed value. Anthropometry, blood-based biomarkers, and hypertension variables were modeled separately to avoid collinearity.

Confounder selection was based on published literature indicating associations between each covariate and both fibroids and blood pressure and a directed acyclic graph (eFigure 2 in Supplement 1 ). We ran unadjusted models and models adjusted for the baseline value of the exposure, age, 1 study site, educational attainment (less than high school, high school, some college and/or technical school, college graduate, or postgraduate), 28 , 29 self-reported race and ethnicity (Black, Chinese, Hispanic, Japanese, or White), 29 , 30 smoking status (current smoker vs nonsmoker), 31 , 32 menopause status (perimenopausal, premenopausal or pregnant or breastfeeding, or unknown due to hormone use), 30 , 33 parity (0, 1-2, ≥3 births), 30 and BMI (continuous) 34 , 35 (minimally adjusted models). Finally, we ran models including all covariates in the minimally adjusted model plus time-varying health care utilization variables reflecting behavior since the prior visit: times spoken to a health care practitioner (0, 1-2, or ≥3 times), use of multivitamins (yes or no), use of calcium supplements (yes or no), and mammogram (yes or no) (health care–adjusted models).

We further adjusted blood pressure models for antihypertensive medication use, and cholesterol and triglyceride models for statin use. Models of antihypertensive treatment vs no treatment were restricted to participants eligible to receive antihypertensive treatment (eTable 2 in Supplement 1 ).

Consistent with recommendations issued by the American Statistical Association, 36 - 38 we interpret results according to the magnitude and direction of point estimates, width of 95% CIs, and pattern of findings across models, rather than statistical significance testing. Analyses were conducted using SAS statistical software 9.4 (SAS Institute).

In sensitivity analyses, to explore the role of gynecological symptoms or care, we repeated analyses restricted to participants who reported a pelvic examination, abnormal bleeding, or pelvic pain since the prior visit. To assess the effect of carrying forward observations to fill missing values, we repeated the main analysis without filling missing values (complete case analysis). Finally, we repeated analyses without censoring at menopause, and without adjusting for baseline values of exposure variables.

The eligible population of 2570 participants had a median (IQR) age of 45 (43-48) years. With regard to race and ethnicity, 644 (25.1%) were Black, 212 (8.3%) were Chinese, 235 (9.1%) were Hispanic, 223 (8.7%) were Japanese, and 1256 (48.9%) were White. A total of 1079 participants (42.1%) had a college education or greater, and 1398 (54.8%) were premenopausal ( Table 1 ). Compared with participants with a history of fibroids, eligible participants were less likely to be Black (644 participants [25.1%] vs 284 participants [42.4%]), to have BMI 30 or greater (630 participants [25.7%] vs 195 participants [29.8%]), and to use antihypertensive medication (333 participants [13.0%] vs 120 participants [17.9%]) (eTable 1 in Supplement 1 ). Over follow-up, 526 participants (20% of eligible) reported a new diagnosis of fibroids.

We found no association between continuous blood pressure and new reported fibroid diagnosis ( Table 2 ). However, participants with new-onset hypertension had a 45% higher risk of new reported fibroid diagnosis (HR, 1.45; 95% CI, 0.96-2.20) compared with never-hypertensive participants, whereas those with preexisting hypertension did not have higher risk. Similarly, participants with untreated hypertension had a 19% (HR, 1.19; 95% CI, 0.91-1.57) greater risk of new reported fibroid diagnosis compared with those with no hypertension, whereas those with treated hypertension had a 20% lower risk (HR, 0.80; 95% CI, 0.56-1.15).

Participants eligible to use antihypertensive medication were more likely than the overall study population to be non-Hispanic Black and have BMI 30 or higher (eTable 2 in Supplement 1 ). Among participants eligible to use antihypertensive treatment, those using antihypertensive treatment had a 37% lower risk of new reported fibroid diagnosis (HR, 0.63; 95% CI, 0.38-1.05); reduction in risk was especially pronounced among participants using ACE inhibitors compared with those using no antihypertensive treatment (48% lower risk; HR, 0.52; 95% CI, 0.27-1.00) ( Table 2 ).

Anthropometry, lipids, and hsCRP were not associated with risk of new reported fibroid diagnosis. For each 0.1-unit increase in waist-to-hip ratio, the risk of newly developed fibroids increased by 29% (HR, 1.29; 95% CI, 1.02-1.63), but there were no associations with BMI, waist circumference, lipids, or hsCRP ( Table 2 ). In sensitivity analyses, the findings slightly attenuated in models restricted to participants who reported a pelvic examination, abnormal bleeding, or pelvic pain since the prior visit (63%-72% of participants); in models without carried forward observations to fill missing values; in models that did not censor at menopause (postmenopausal participants increased from 2% at visit 1 to 99% at visit 13); and in models without adjustment for baseline exposure values (eTables 3-6 in Supplement 1 ).

In this longitudinal cohort study with repeated measures of both cardiovascular risk factors and self-reported fibroid diagnosis, patients with new-onset hypertension had a 45% increased risk of newly reported fibroids, and those with untreated hypertension had a 19% increased risk. Participants who used antihypertensive medication had lower risks of newly reported fibroids: 20% lower risk compared with participants without hypertension, and 37% lower risk (for ACE inhibitors, 48% lower risk) compared with untreated participants eligible to use antihypertensive medication. These findings suggest that new hypertension is associated with elevated risk of first fibroid diagnosis at midlife, a high-risk time for both fibroid diagnosis and the development of cardiovascular risk.

Our finding that risk of new reported fibroid diagnosis was higher among participants with untreated vs treated hypertension, whereas continuous blood pressure was not associated with risk, adds important new insights to a conflicting literature. Both the Black Women’s Health Study, a prospective cohort of premenopausal Black women, and the Nurses’ Health Study II, a prospective cohort of nurses aged 25 to 42 years at baseline, found that higher blood pressure was associated with greater fibroid incidence regardless of antihypertensive use. 14 , 16 We also found that new-onset hypertension carried greater risk of newly reported fibroids than ongoing hypertension, which differs from prior research suggesting either sustained elevation 14 or no change 16 in fibroid risk after hypertension diagnosis. Our findings may differ from prior literature for many reasons. Importantly, we relied on technician-measured blood pressure to ascertain hypertension status, thereby reducing misclassification; participants with untreated hypertension may not be aware of their hypertension. Also, previous studies less precisely ascertained hypertension onset, which may have attenuated the associations. Finally, prior cohort studies included a wider age range (eg, approximately 20-80 years in some cases 14 - 16 ), possibly diluting associations. Nonetheless, our results add to the prospective evidence linking untreated hypertension to risk of newly clinically apparent fibroids.

Our related finding among participants eligible to use antihypertensive medication that those using antihypertensive medication had a 37% lower risk of newly reported fibroids, and those using ACE inhibitors in particular had 48% lower risk, is consistent with a recent commercial insurance database study that reported that ACE inhibitor use was associated with 32% reduced odds of new fibroid diagnosis. 22 Preliminary evidence suggests that the renin-angiotensin-aldosterone pathway may explain a protective effect of ACE inhibitors: angiotensin II and aldosterone have been shown to cause fibroid cell proliferation in a rat cell line, 39 , 40 and mixed evidence from human genetic studies 41 suggests that fibroid risk is associated with angiotensin II receptor type 1 genetic sequence variants 42 and angiotensin-converting enzyme insertion-deletion genetic sequence variants. 43 , 44 The renin-angiotensin-aldosterone pathway deserves further exploration in light of our findings suggesting reduction of fibroid risk associated with ACE inhibitors.

Alternatively, associations between new-onset hypertension and newly reported fibroid diagnosis may be due to bias. For example, unmeasured comorbidities could increase both blood pressure and health care utilization, leading to incidental fibroid diagnosis; however, results were robust to adjustment for health care utilization and sensitivity analyses restricting to participants with a pelvic examination or symptoms. Reverse causation is also possible: a growing fibroid might increase blood pressure through vascular demands 4 or altered systemic hemodynamics. 45

Although a growing literature links cardiovascular risk factors to prevalent fibroids, nearly all studies have been cross-sectional in design. In this prospective study, we reported null associations between lipids, CRP, anthropometry (except waist-to-hip ratio), and incidence of fibroids. Prior studies have reported mixed findings for the association between cholesterol and fibroids, with some linking fibroids to higher low-density lipoprotein and lower high-density lipoprotein cholesterol, 7 , 11 , 13 , 46 some suggesting the opposite, 47 and others reporting null associations. 5 , 48 , 49 The only prior study to investigate associations between CRP and fibroid prevalence reported null associations. 50 Prior literature has reported nonlinear associations between BMI and fibroids (highest risk for BMI approximately 28-32) and both positive and null associations between waist-to-hip ratio and fibroids. 7 , 34 , 51 - 53 Previous studies varied widely in design, which may also explain heterogeneity; for example, some relied on retrospective analyses (eg, lifetime fibroid occurrence), 5 clinical convenience samples, 11 or surgically confirmed cases. 54 Our null findings in a longitudinal cohort study with criterion-standard biomarker measurements do not support an effect of lipids or CRP on new fibroid diagnosis in midlife participants.

Our analysis benefited from high-quality, repeated measurements of blood pressure, biomarkers, and anthropometry, enabling us to assess exposures independent of health care access. SWAN’s midlife participants and criterion-standard assessment of menopause status allowed us to focus on a high-risk life stage. 55 Finally, we adjusted for a wide range of potential confounding factors, including health care utilization (an especially strong confounder of associations between medication use and fibroid diagnosis).

Our work also has limitations. First, we used self-reported fibroid diagnosis; therefore, asymptomatic fibroids, which may constitute more than one-half of cases, 2 may be missed. Complete fibroid ascertainment (ie, repeated ultrasonography of asymptomatic participants) is difficult, and all prior prospective studies of hypertension and fibroids also relied on self-reported diagnosis. 14 - 16 Self-reported fibroid diagnosis has high specificity 19 ; sensitivity is estimated to be approximately 50% for women aged 35 to 49 years. 19 Because fibroid misclassification is unlikely to vary by study-measured hypertension status and specificity is high, despite lower sensitivity, effect estimates are expected to be unbiased. 56 On the other hand, if participants with study-measured hypertension had lower rates of missed fibroid diagnosis than those with normotension, the magnitude of our associations would be overstated. Second, the eligibility criteria may limit generalizability. Fibroids often develop before midlife, especially for Black women 28 ; in this study, Black participants were more likely to be excluded because of prior fibroids. Findings are most applicable to those with a first fibroid diagnosis in midlife. Fibroids may grow slowly 57 and may have been present but undiagnosed before hypertension onset. However, prospective associations between new-onset hypertension and fibroid diagnosis suggest that high blood pressure plays a role in fibroid growth to the point of clinical recognition. Participants using ACE inhibitors may differ from those using other antihypertensive medications or no medications; further investigation is needed to determine the causal effect of ACE inhibitor use on fibroid risk. Furthermore, we could not rule out unmeasured confounding but were able to adjust for multiple demographic and health care utilization variables.

This study of a midlife cohort found that patients with untreated and new-onset hypertension had increased risk of newly reported fibroid diagnosis, whereas those taking antihypertensive medication had a reduced risk. Investigation into mechanisms and health implications is warranted; if the associations are causal, antihypertensive medication use where indicated may present an opportunity to prevent clinically apparent fibroid development at this high-risk life stage.

Accepted for Publication: February 18, 2024.

Published: April 16, 2024. doi:10.1001/jamanetworkopen.2024.6832

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Mitro SD et al. JAMA Network Open .

Corresponding Author: Susanna D. Mitro, PhD, Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612 ( [email protected] ).

Author Contributions: Dr Mitro had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Mitro, Zaritsky, Solomon, El Khoudary, Hedderson.

Acquisition, analysis, or interpretation of data: Mitro, Wise, Waetjen, Lee, Zaritsky, Harlow, Thurston, El Khoudary, Santoro, Hedderson.

Drafting of the manuscript: Mitro, Wise, Zaritsky, Harlow, El Khoudary, Santoro.

Critical review of the manuscript for important intellectual content: Mitro, Wise, Waetjen, Lee, Zaritsky, Harlow, Solomon, Thurston, El Khoudary, Hedderson.

Statistical analysis: Mitro, Wise, Santoro.

Obtained funding: Waetjen, Harlow, Thurston, El Khoudary, Hedderson.

Administrative, technical, or material support: El Khoudary, Santoro.

Supervision: Wise, Waetjen, Lee, Zaritsky, Thurston, El Khoudary, Hedderson.

Conflict of Interest Disclosures: Dr Wise reported receiving grants from the National Institutes of Health (NIH), personal fees from The Gates Foundation and Abbvie, Inc, and in-kind donations for primary data collection in a study outside the submitted work from Swiss Precision Diagnostics (home pregnancy tests) and Kindara.com (fertility applications). Dr Waetjen reported receiving grants from Accessa Health Inc outside the submitted work. Dr Solomon reported receiving grants from CorEvitas, Janssen, and Novartis outside the submitted work. Dr Thurston reported receiving personal fees from Astellas Pharma, Bayer, Hello Therapeutics, Happify Health, and Vira Health outside the submitted work. Dr Santoro reported receiving grants from Menogenix, Inc, and personal fees from Astellas Pharma, Ansh Labs, Amazon, and FertilityIQ outside the submitted work. No other disclosures were reported.

Funding/Support: The Study of Women’s Health Across the Nation (SWAN) has grant support from the NIH, Department of Health and Human Services, through the National Institute on Aging (NIA), the National Institute of Nursing Research (NINR), and the NIH Office of Research on Women’s Health (ORWH) (grants U01NR004061, U01AG012505, U01AG012535, U01AG012531, U01AG012539, U01AG012546, U01AG012553, U01AG012554, U01AG012495, and U19AG063720; the SWAN Repository is funded through grant U01AG017719). This publication was supported in part by the National Center for Research Resources and the National Center for Advancing Translational Sciences, NIH (UCSF-CTSI grant UL1 RR024131). Dr Mitro is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the NIH (award number K12AR084219).

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the NIA, NINR, ORWH, or the NIH.

Data Sharing Statement: See Supplement 2 .

Additional Contributions: We thank the study staff at each site and all the women who participated in SWAN. Clinical centers included University of Michigan, Ann Arbor (principal investigators [PIs], Carrie Karvonen-Gutierrez, 2021 to present; Siobán Harlow, 2011-2021; MaryFran Sowers, 1994-2011); Massachusetts General Hospital, Boston (PIs, Sherri-Ann Burnett-Bowie, 2020 to present; Joel Finkelstein, 1999-2020; Robert Neer, 1994-1999); Rush University, Rush University Medical Center, Chicago, Illinois (PIs, Imke Janssen, 2020 to present; Howard Kravitz, 2009-2020; Lynda Powell, 1994-2009); University of California, Davis, and Kaiser Permanente, Oakland, California (PIs, Elaine Waetjen and Monique Hedderson, 2020 to present; Ellen Gold, 1994-2020); University of California, Los Angeles (PIs, Arun Karlamangla, 2020 to present; Gail Greendale, 1994-2020), Albert Einstein College of Medicine, Bronx, New York (PIs, Carol Derby, 2011 to present; Rachel Wildman, 2010-2011; Nanette Santoro, 2004-2010); University of Medicine and Dentistry–New Jersey Medical School, Newark (PIs, Gerson Weiss, 1994-2004); University of Pittsburgh, Pittsburgh, Pennsylvania (PIs, Rebecca Thurston, 2020 to present; Karen Matthews, 1994-2020); NIH Program Office, National Institute on Aging, Bethesda, Maryland (PIs, Rosaly Correa-de-Araujo, 2020 to present; Chhanda Dutta, 2016 to present; Winifred Rossi, 2012-2016; Sherry Sherman, 1994-2012; Marcia Ory, 1994-2001); National Institute of Nursing Research, Bethesda, Maryland, Program Officers; central laboratory, University of Michigan, Ann Arbor (PI, Daniel McConnell; Central Ligand Assay Satellite Services); SWAN repository, University of Michigan, Ann Arbor (PIs, Siobán Harlow, 2013-2018; Dan McConnell, 2011-2013; MaryFran Sowers, 2000-2011), coordinating center, University of Pittsburgh, Pittsburgh, Pennsylvania (PIs, Maria Mori Brooks, 2012 to present; Kim Sutton-Tyrrell, 2001-2012); New England Research Institutes, Watertown, Massachusetts (PI, Sonja McKinlay, 1995-2001), and steering committee (Susan Johnson, current chair; Chris Gallagher, former chair).

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• Open access
• Published: 30 September 2024

Continuous adaptation of conversation aids for uterine fibroids treatment options in a four-year multi-center implementation project

• Danielle Schubbe 1 ,
• Marie-Anne Durand 1 , 2 ,
• Rachel C. Forcino 3 ,
• Jaclyn Engel 1 ,
• Marisa Tomaino 4 ,
• Monica Adams-Foster 1 ,
• Carla Bacon 5 ,
• Carrie Cahill Mulligan 1 ,
• Sateria Venable 6 ,
• Tina Foster 1 ,
• Paul J. Barr 1 ,
• Raymond M. Anchan 7 ,
• Shannon Laughlin-Tommaso 8 ,
• Anne Lindholm 7 ,
• Maya Seshan 7 ,
• Rossella M. Gargiulo 7 ,
• Patricia Stephenson 1 ,
• Karen George 9 ,
• Mobolaji Ajao 7 ,
• Tessa Madden 10 ,
• Erika Banks 11 ,
• Antonio R. Gargiulo 7 ,
• James O’Malley 1 ,
• Maria van den Muijsenbergh 12 ,
• Johanna W. M. Aarts 13 &
• Glyn Elwyn 1  

BMC Medical Informatics and Decision Making volume  24 , Article number:  277 ( 2024 ) Cite this article

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Fibroids are non-cancerous uterine growths that can cause symptoms impacting quality of life. The breadth of treatment options allows for patient-centered preference. While conversation aids are known to facilitate shared decision making, the implementation of these aids for uterine fibroids treatments is limited. We aimed to develop two end-user-acceptable uterine fibroids conversation aids for an implementation project. Our second aim was to outline the adaptations that were made to the conversation aids as implementation occurred.

We used a multi-phase user-centered participatory approach to develop a text-based and picture-enhanced conversation aid for uterine fibroids. We conducted a focus group with project stakeholders and user-testing interviews with eligible individuals with symptomatic uterine fibroids. We analyzed the results of the user-testing interviews using Morville’s Honeycomb framework. Spanish translations of the conversation aids occurred in parallel with the English iterations. We documented the continuous adaptations of the conversation aids that occurred during the project using an expanded framework for reporting adaptations and modifications to evidence-based interventions (FRAME).

The first iteration of the conversation aids was developed in December 2018. Focus group participants ( n  = 6) appreciated the brevity of the tools and suggested changes to the bar graphs and illustrations used in the picture-enhanced version. User-testing with interview participants ( n  = 9) found that both conversation aids were satisfactory, with minor changes suggested. However, during implementation, significant changes were suggested by patients, other stakeholders, and participating clinicians when they reviewed the content. The most significant changes required the addition or deletion of information about treatment options as newer research was published or as novel interventions were introduced into clinical practice.

Conclusions

This multi-year project revealed the necessity of continuously adapting the uterine fibroids conversation aids so they remain acceptable in an implementation and sustainability context. Therefore, it is important to seek regular user feedback and plan for the need to undertake updates and revisions to conversation aids if they are going to be acceptable for clinical use.

Peer Review reports

Introduction

Fibroids are common non-cancerous uterine growths that can cause heavy and/or prolonged bleeding and symptoms of bulk, such as urinary infrequency, pelvic pressure, and constipation [ 1 ]. There are multiple treatment options available for symptomatic uterine fibroids, each one with different advantages or risks. No single treatment is most effective for all patients and not all treatment options are appropriate for all patients, meaning a treatment decision should ideally depend on a patient’s informed preferences and values [ 2 , 3 , 4 ].

Conversation aids, like Option Grid™, are brief evidence-based interventions designed to support this process, called shared decision making [ 5 , 6 , 7 ]. Our definition of a conversation aid is a patient decision aid that is used to facilitate a shared decision making conversation between a patient and a health professional [ 5 , 8 ]. They are designed for encounter-based use but can be tailored to be used before and after an encounter [ 7 ]. Option Grids are written in plain language with high readability (6th grade or 12 years old). They are developed using an iterative user-centric process compatible with the International Patient Decision Aids Standards (IPDAS) [ 9 ]. A previous version of the uterine fibroids Option Grid has been shown to facilitate shared decision making in the context of uterine fibroids treatment decisions [ 10 , 11 ].

Conversation aids with pictures are shown to be especially useful in increasing understanding and information recall [ 12 , 13 , 14 , 15 , 16 ]. According to a recent systematic review, pictures in health information largely improve comprehension for lower health literacy populations [ 16 ]. For displaying risk information, prior studies have revealed varying format preferences and levels of understanding [ 17 , 18 ].

IPDAS indicates that relevant users of a conversation aid should be embedded in the development of the interventions [ 19 ]. A recent systematic review found that conversation aids are frequently developed using user-centered participatory approaches [ 20 ]. User-centered design approaches may improve the implementation of conversation aids [ 21 ]. User-centered participatory approaches are often iterative and require multiple steps [ 20 ]. We know of no existing text-based or picture-enhanced uterine fibroids conversation aids being widely implemented in diverse clinical settings. In a multi-site implementation project of two uterine fibroids conversation aids, our broad project team (including researchers, clinicians, and patients with experience with symptomatic uterine fibroids) developed and iterated two conversation aids for uterine fibroids [ 22 ]. Our first objective for this research was to develop a current and acceptable text-based Option Grid and a picture-based version and provide translated versions in Spanish using a multi-phase user-centered participatory approach [ 22 , 23 ]. Our second objective was to outline the iterative adaptation approach that keeps the Option Grids current and relevant using FRAME, an expanded framework for reporting adaptations and modifications to evidence-based interventions [ 24 ].

All methods and results are in alignment with the COnsolidated criteria for REporting Qualitative research (CORE-Q) checklist criteria [ 25 ]. Please see supplemental file 1.

Option Grid patient conversation aids are created by synthesizing evidence-based information about the benefits and harms of available treatment and screening options, and communicating those findings in a patient-friendly tabular format. We followed a multi-phase user-centered participatory approach to developing and adapting the uterine fibroid treatment options conversation aids. Multiple steps are common for user-centered participatory approaches to conversation aid development [ 20 ]. Specifically, there were six documented phases of this development work.

Create initial textual content for uterine fibroids treatment options Option Grid

Create prototypes of the Option Grid (text-based) and Picture Option Grid (picture-enhanced) and seek feedback from stakeholders

Conduct a focus group with the broader project’s Community Advisory Board

Conduct user-testing interviews with end-users of the Option Grid

Translate and test for acceptability the final approved Option Grid and Picture Option Grid

Track adaptations made to the Option Grid and Picture Option Grid

Phase 1—Initial development of content

Setting and participants.

EBSCO DynaMed, a group of “clinical experts, scientists, methodologists, specialized medical writers and editors and medical librarians,” generated the initial content of the uterine fibroids Option Grid [ 26 ].

EBSCO DynaMed’s editorial process includes the following steps: (1) Identifying the evidence, (2) Selecting the best evidence available, (3) Critical appraisal, (4) Objectively reporting the evidence, (5) Synthesizing multiple evidence reports, (6) Basing conclusions on the evidence, and (7) Updating daily [ 27 ]. Please see supplemental file 2 for an abbreviated description of the development process EBSCO DynaMed uses to develop Option Grids.

Prior to the start of this study, EBSCO DynaMed followed a 45-step process to create the initial content for the uterine fibroids treatment Option Grid (see supplemental file 2). The process involved topic scoping frequently asked questions scoping, evidence gathering, evidence evaluation and synthesis, patient-friendly translation (6th-grade reading level and below), and finalization review.

Phase 2—Prototype development

This study is part of a broader randomized stepped-wedge implementation study of the uterine fibroids Option Grids [ 22 ]. The five participating sites that were randomized to implement the Option Grids at different time points are gynecology clinics at (1) Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire; (2) Washington University/Barnes-Jewish Hospital in St. Louis, Missouri; (3) Montefiore Medical Center in Bronx, New York; (4) Brigham and Women’s Hospital in Boston, Massachusetts; and (5) Mayo Clinic in Rochester, Minnesota. Sites were chosen based on their diversity (racial, ethnic, and geographic) and interest in and capability of implementing shared decision making tools.

The iterative prototype development process included our broader project’s Community Advisory Board (CAB) and Steering Committee members. Our CAB was composed of 10 individuals. Among five patient partners, two represented different national fibroid advocacy organizations, and two were Black women. Patient partners ranged in geographical location, including rural and urban. Other CAB members included one payer organization representative, one national health insurance clinician representative, and one expert clinician in fibroid care. We selected members of the CAB for their experience or expertise in the multifaceted subject matter of uterine fibroids. They participated in quarterly meetings during the full project duration (June 2018 to January 2023) and were included in regular project communications and requests for feedback. The broader project’s Steering Committee was composed of seven clinician stakeholders, all patient partners, participating site research staff, and two subject matter expertise stakeholders. They participated in quarterly meetings during the full project duration and were included in regular project communications and requests for feedback.

Working with a professional illustrator and based on synthesized and summarized content from EBSCO DynaMed , researchers (M-AD and DS), in collaboration with other project members, created prototypes of Option Grid (text-based and in a tabular format) and Picture Option Grid (picture-enhanced) and then sought feedback from numerous stakeholders, including individuals with symptomatic uterine fibroids. We received feedback at our first site visits to each of the project sites in January and February 2019, and we also received feedback at regularly scheduled monthly team meetings, Steering Committee meetings, and CAB meetings during 2019. We collated Phase 2 feedback in a spreadsheet the project team used to relay information to EBSCO and the project’s illustrator.

Phase 3—Feedback for picture-enhanced conversation aid

Focus group participants included the project’s CAB. The focus group was conducted using Dartmouth’s HIPAA-compliant Zoom.

A researcher (DS) conducted a focus group with the CAB in 2019 using an interview guide that explored their overall thoughts about the recently updated Picture Option Grid. The interview guide was also used to seek their opinions about the layout, organization, colors, pictures, and bar graphs in the Picture Option Grid. The interview guide was reviewed and finalized by the Dartmouth project team before the focus group (see supplemental file 3).

Focus group participants had time to review the Picture Option Grid in advance. Planned discussion topics included overall thoughts and opinions about the layout, organization, and colors; specific questions about the pictures and illustrations and the bar graph representations of the statistical information; and specific areas that could be improved. The focus group was audio recorded and transcribed verbatim (DS).

Interviewer characteristics

The researcher who conducted the focus group with the project’s CAB as well as the user-testing interviews with individuals with symptomatic uterine fibroids (DS) was a female research assistant who held a bachelor’s degree. The researcher had previous experience conducting focus groups and was trained in qualitative interview methods such as probing and redirection. The researcher had an established relationship with the project’s CAB since she facilitated all quarterly CAB meetings. However, she did not have an established relationship with the user-testing interviewees. Still, they were made aware of her involvement in the broader project and knew of the broader project’s reasons for conducting the study.

Phase 4—User-testing versions of both conversation aids

We identified a convenience sample of individuals with symptomatic uterine fibroids for the user-testing interviews. We worked with a CAB member to post a brief summary about participation in the study on their advocacy organization's Facebook page, which includes uterine fibroids patients across the United States. Interested individuals reached out by email to participate.

Seventeen individuals were approached by research staff (DS) via email to participate in the user-testing interview. Five individuals did not respond to the email, and three individuals could not participate due to the timing and technological requirements to conduct the interview. Nine total interviews were conducted with patients with symptomatic uterine fibroids. No other individuals were present during participant interviews.

We developed a user-testing interview guide and analyzed interview transcripts using Morville’s user experience framework [ 28 ]. This framework has previously been used to user-test conversation aids.[[ 29 , 30 , 31 ] The framework uses seven domains associated with a user’s experience of an intervention: usability, usefulness, credibility, desirability, value, findability and accessibility (see Fig.  1 ) [ 32 ].

Morville’s user-experience ‘honeycomb’ framework

The first domain, usable, specifies that the product delivered (the conversation aid), needs to be simple and easy to use. The second domain, useful, says that the product needs to fill a need. Desirable, the third domain, requires that the visual aesthetics of the product need to be attractive, easy to translate, minimal, and to the point. The fourth domain, findable, necessitates that the information provided needs to be easy to navigate. The navigational structure should be set up in a way that makes sense. Accessible, the fifth domain, notes that the product should be designed so that all kinds of users (at all levels of ability) can have the same experience. The second to last domain, credible, describes that the company that makes the product and the product itself needs to be trustworthy. The final domain, valuable, is a compilation of all the other domains. A product cannot be deemed valuable without satisfying all seven domains.

The Phase 4 user-testing interview guide was reviewed by the Dartmouth project team before commencing user-testing interviews (see supplemental file 4). The semi-structured interviews were conducted with a convenience sample of nine individuals over Zoom teleconferencing system in July 2019. The researcher (DS) conducted the interviews to assess the usability, acceptability, and accessibility of the final versions of the two conversation aids. The researcher (DS) contacted individuals and conducted interviews until data saturation was reached. Each user-testing participant was compensated $15 for their interview. The interviews were recorded and transcribed using a HIPAA-compliant transcription company. All recordings and transcriptions were stored using Dartmouth Sharepoint, a HIPAA-compliant web platform. As the transcriptions were verbatim, the researcher (DS) did not take field notes while conducting the interviews.

Phase 5—Translation of conversation aid content

A bilingual researcher assisted in the Translation, Review, Adjudication, Pretest, Documentation (TRAPD)-adapted translation procedure. The same bilingual researcher identified a convenience sample of native Spanish speakers living in the United States using their social network.

Our TRAPD-adapted translation approach included the four main stages: (1) Two Spanish speakers created independent translations of the original text; (2) a bilingual reviewer compared the original text, translation 1, and translation 2 and either selected the preferred translation or produced a third translation that built on the previous two; (3) the bilingual reviewer met with the project team to review and reconcile translations by consensus; and (4) the resulting translation was tested via cognitive debriefing interviews [ 33 ]. A bilingual researcher conducted the semi-structured cognitive debriefing interviews with a convenience sample of seven native Spanish speakers residing in the United States to ensure the understanding and readability of the uterine fibroids conversation aids. Each cognitive interview participant received a $10 honorarium.

Phase 6—Tracking continuous adaptations

After gathering all of the above data, we reflected and adapted FRAME to describe the adaptations to the Option Grids throughout the course of the implementation project.

Two researchers (DS and RF) independently coded the Phase 3 focus group and Phase 4 user-testing interviews. A third researcher (MAD) was available for arbitration. The Phase 3 focus group was inductively coded to identify elements that pertain to the usability, acceptability, and accessibility of the Picture Option Grid. The Phase 4 user-testing interviews were analyzed in two rounds. One researcher (DS) conducted the first round of coding solely looking for explicit suggested changes on the tools so the broader project team could finalize the two tools. Two independent researchers (DS and RF) simultaneously conducted the second coding round using framework analysis (based on the ‘honeycomb’ framework). The transcripts were inductively coded to identify elements that pertained to the usability, acceptability, and accessibility of both of the tools. We used ATLAS.ti software for our coding and codebook development. All codes were reviewed by the three researchers (DS, RF, MAD—expert arbitrator) to determine the final major and minor themes.

Phase 1 EBSCO content creation

The first Option Grid developed by EBSCO in December 2018 listed six treatment options for uterine fibroids in no particular order or arrangement but separated into two separate grids because of space issues. The first grid listed information for treatment with hormones, medicine without hormones, and myomectomy. The second grid listed information for fibroid destruction, endometrial ablation, and hysterectomy.

Phase 2 prototype development results

Based on stakeholder feedback of the original version that EBSCO created, there was a push to be more specific about the names of the treatment options/procedures, add “ watch and wait ” as an option, organize the options by treatment intensity, and add brief definitions for some of the treatment options in the top row. Two more versions were developed after collecting feedback (March 2019, April 2019).

At this point, we had worked with the illustrator on developing a picture-enhanced prototype of the Option Grid (called Picture Option Grid). The illustrations were originally drafted in March 2019, and a second round of illustrations was commented on in April 2019. The first prototype of the Picture Option Grid was completed in May 2019 in preparation for the Phase 3 focus group.

Phase 3 focus group results

Our focus group was held at a regularly scheduled CAB quarterly meeting in May 2019. Six out of 10 members (3 patient partners, 1 clinician, 2 researchers) were present. The focus group lasted thirty minutes and covered questions specific to the Picture Option Grid, as we were in the illustration phase of the intervention development at that time.

The focus group participants had a positive appraisal of and did not suggest any major changes to the Picture Option Grid. They emphasized the importance of the concise nature of the conversation aid. Specific feedback was collected on certain illustrations, including clarifying the meaning of the traffic lights representation and making the bar graphs easier to understand. However, some focus group participants agreed that the bar charts might be difficult for some to interpret.

“I like the traffic light symbol. I think it’s clear. I think the improved graphics are much easier to read and comprehend.”

“I think you could clean them (traffic lights) up a little bit. I’m not sure the people walking in the middle are necessary or the line through the yellow and red is necessary.”

“I usually see bar graphs vertically. The vertical bar charts are clearer. I also don’t love the icons, but I think it’s going to have to do with how people best receive and interpret information.”

The patient partners also focused on the location and size of the fibroids illustrations throughout the Picture Option Grid, and we adjusted our illustrations accordingly. Participants agreed that the Picture Option Grid is a “ nice, clean depiction that we are being mindful of using excess words or images. ”

Phase 4 user-testing results

Participants ( n  = 9) were all women who had experience with symptomatic uterine fibroids and ranged in age from 32 to 50 (an average of 42 years old). All interview participants had higher education: one associate’s degree, four master’s degrees, and four doctorates. Interview participants ranged in location from California to New York. About half of the participants interviewed identified as Black. Interviews were between 15 min and 1 h long. See Table  1 for user-testing interview participant characteristics.

Feedback collected during the interviews included comments about the image of the needle for uterine artery embolization being too intimidating and that it should be reduced in size. Comments were also made about the graph fill needing to be a different color to provide more contrast. Lastly, two interview participants mentioned it would be convenient to have the conversation aids available online.

The results below are organized by each domain of Morville’s user experience honeycomb framework.

Overall, the interview participants found that the conversation aids help to compare options and are easy to understand. Participants who were interviewed felt that the two conversation aids helped compare the numerous treatment options for symptomatic uterine fibroids. They reported the amount of information provided in the conversation aids was sufficient to help facilitate a shared decision making discussion between the patient and clinician.

“ I think that [the conversation aid] is a great way to make a decision or at least have help with the decision because it’s a lot of information to take in. Not everybody is a surgery person, not every case is exactly the same. To have choices really makes the difference for people. ” - ID 01

Some participants found the text-only Option Grid easier to understand because of its simpler layout. Most participants conceptually liked the idea of the Picture Option Grid and could understand how the pictures would be helpful for comprehension. Some participants had specific feedback regarding certain pictures and their meanings, including the bar graphs. Some found the bar graphs redundant and found that looking at the accompanying text was more helpful.

“ I would say this one [Picture Option Grid] probably lends itself to increasing the potential of understanding and comprehension because you can envision your body when you look at this, when you absorb the information. The first one [Option Grid] appeals to the analytical mind, such as myself, particularly when you’ve had roles and responsibilities using that type of data. From an intellectual perspective, the first one is great because it still gives you what you need. From the emotional response and reaction, the graphics do a better job in terms of the consultation with the doctor. ” - ID 02

Overall, the interview participants thought the tools had good questions, good information, and served as a good starting point.

The interview participants felt that using the tools was practical, given the flexibility of use, and would help start the conversation about their treatment options. A couple of patients thought that the statistics provided in both conversation aids were not helpful.

“ I think it’s a great conversation starter. I think that the whole idea here is if we’re talking upfront, it does a good job of opening the dialogue to the deeper conversations of practical application, then of selection of choice. ” - ID 04

“...when I was discussing it with my doctor, I didn’t have any of these and I would try to think of questions to ask. I would almost always come out with the question after I left the appointment. If this was there, then I could only have it there and then she could expound on the answers that were already given to help make an informed decision.” - ID 02

“ The percentages are really useless to me. ” - ID 08

Participants thought the idea of receiving the conversation aids before their treatment option discussion would be helpful. They noted it would assist in absorbing the information so they can come to their clinic appointment with more personal, focused, and specific questions. Participants also highlighted the importance of taking the tools home for further deliberation.

“ Yes, because sometimes the doctor is talking and you’re kind of listening but if you have something you can take home and sit down in your own time and go through. Personally, for me, that works better for me. ” - ID 01

“ I think it would be practical to receive it before the appointment. ” - ID 04

“... I think having it beforehand might lessen some of that feeling because you’re processing it, you’re thinking about it, and then when you get to the doctor and you want to sit down and talk, he or she can clarify things for you. ” - ID 01

Overall, participants preferred the Option Grid for its more concise nature but also enjoyed the picture representations in the Picture Option Grid.

Participants found the Option Grid layout appealing and concise. Among our sample of interview participants, the Option Grid was preferred over the Picture Option Grid. Most participants liked the picture representations in the Picture Option Grid, but they had mixed feelings about the bar graphs.

“ Personally, my preference is just to have the text. ” - ID 02

“ Like I said before, I think the visual is extra helpful to know. (...) I think having a visual representation is useful for all kinds. ” - ID 06

Overall, the participants thought the conversation aids were well-organized. Participants liked the layout of the Option Grid.

Participants found the grouping of the treatment options made sense, and the conversation aids were well-organized. They also felt the Option Grid was easier to navigate because of its tabular structure.

“ I think that it’s [Option Grid] nice. It’s like a crosswalk type of approach, so I think it’s a familiar format for people. ” - ID 08

“ The grouping of treatment options makes sense considering they represent different levels of severity of options. ” - ID 09

“ I like the way that it breaks out into expectations, to what’s actually involved – the expectations, I like the discussion of symptoms and I like kind of understanding the spectrum of risk .” - ID 08

Participants felt the conversation aids were broadly accessible because they used plain language. However, the bar graphs may be difficult for some people to understand. Participants have different preferences for which conversation aid they would want to receive. They also highlighted the importance of providing conversation aids in other languages or ensuring an interpreter is available.

“ I think the text is easy to read. I don’t feel like you have to have any kind of medical or scientific background to understand what the text is saying. ” - ID 08

“ You have...the bars - I don’t know if that’s necessarily helpful for your average woman out there or average education level. ” - ID 02

“ I did like the first one a little bit better [Option Grid], but this one [Picture Option Grid], I do think it’s good if you’re a visual learner. I guess it depends on your style of what you prefer. ” - ID 05

Participants trusted the information in the conversation aids, provided that it was coming from their doctor. Nobody interviewed mentioned that conflict of interest information would be helpful or necessary in the conversation aid.

“ I’ve done some research on some of the ways to treat fibroids, and it looks very similar, so it’s definitely the treatments that have been out there. ” - ID 05

Both tools were deemed valuable by the participants. Participants found both pros and cons for each conversation aid, highlighting the importance of individual preference in choosing which conversation aid to use.

“ I think it’s very helpful. Like I said before, I would like to have had something like this when I first was told that I have fibroids. ” - ID 03

“ For me, it’s a personal choice because everybody is different in their learning methods. ” - ID 02

Phase 6 FRAME results

As the broader implementation project went on, we continued to collect feedback from clinical and patient stakeholders. We made subsequent modifications to both the text-based Option Grid and the picture-enhanced Picture Option Grid. Please see Table  2 below which describes the major changes to the tools over time according to FRAME. All adaptations were (1) at the intervention level of modification delivery, (2) content level modifications, and (3) considered fidelity consistent in that it kept the tools relevant and useful. Any adaptations to the tools over time resulted in updated Spanish translations as well.

Please see Fig.  2 a-c for a visualization of the modifications to the Picture Option Grid over the course of the project. See supplemental files 5–8 to view full versions of the Picture Option Grid shown in Fig.  2 a-c.

a - c Evolution of the picture option grid

The six phases of developing and tracking adaptations of the conversation aid informed us that continuous updating of the Option Grid is needed for successful implementation and sustainability, especially if the tools will be used across diverse settings over many years. Phase 3 focus group members suggested minor changes to the bar graphs and traffic lights on the Picture Option Grid. Overall, they liked the brevity of the updated Picture Option Grid and did not suggest any major changes. Phase 4 user testing interview participants found that both conversation aids met the criteria for satisfactory user experience. In Phase 6, we organized the major adaptations to the tools using FRAME, noting most main changes were reactive and determined by patient/stakeholder partners and participating clinicians.

A consistent user-centered participatory approach that collects and responds to user and stakeholder feedback facilitates continuous adaptation of the conversation aids. While doing this can slow down the actual implementation work, it is necessary to ensure the usability and acceptability of the conversation aids for sustainability.

Comparison with other literature

We observed that both patients and clinicians had varying preferences for one format over the other (Option Grid versus Picture Option Grid). While we accept that preferences will determine utilization, we emphasized the evidence showing that pictures and visual risk communication strategies can help increase knowledge and understanding, especially for people with lower health literacy [ 16 ]. In our user-testing sample, bar graphs were moderately understood with preference for the text accompanying them, also seen in another study [ 34 ]. Research also shows that bar graphs may be more difficult to understand for individuals with lower graph literacy and fewer years of education [ 35 ].

Another major finding from the user-testing interviews was the benefit to patients of receiving the conversation aids before their visits with their clinician. Bunzli’s study on an orthopedic surgery decision aid also reported this [ 36 ]. Being able to read and process the information ahead of visits helps patients better prepare and take part in discussions about their treatment options.

Our finding that there is a need to continually adapt patient decision aids during implementation processes is echoed by others [ 37 ]. Holtrop et al. emphasize the importance of mental models in implementation science and that adaptations are, therefore, a consequence of learning by understanding the perspectives of end-users [ 38 ]. Adaptations should be appreciated, documented, and evaluated [ 39 ]. Additionally, the iterative process of responsive continuous adaptation created a “ripple effect”: end-users realized that their opinions led to changes and became more interested in successfully implementing the conversation aids [ 40 , 41 ].

Strengths and limitations

One strength of this study was the involvement of key stakeholders from the conversation aids’ inception to real-life implementation. This approach required continual interactions on a regular basis, which provided full transparency of the development progress. Our iterative approach also emphasized the importance of adapting the conversation aids to target population needs, which in turn made them more suitable for sustainability.

“ I feel like I have helped to implement and shape this thing, and to kind of put my hat in the ring on behalf of my own personal community, but then the other communities that I know are oftentimes unrepresented at the upfront stages when things are being discussed. ” - Phase 4 user-testing interview, ID 04

In hindsight, we unintentionally overlooked user-testing the final versions of the conversation aids with clinicians, as they are also end-users of the conversation aids in practice. Including all end-users may be the most effective approach to reducing some implementation barriers [ 42 ]. Another limitation is that most of our user-testing interview participants were more educated and of higher socioeconomic status, which is not representative of the population with symptomatic uterine fibroids and reduces generalizability.

Lessons learned and recommendations

In doing our best to follow an iterative user-centered participatory approach, the adaptation and development of the conversation aids took time, effort, and resources. Beyond strictly developing the conversation aids, we also spent over a year using a trial and error approach to how the conversation aids would be printed for real-life use in practice (text-based Option Grid printed as a tear-off pad, Picture Option Grid printed as an individual document). We learned that in future development efforts, it is important to allow enough time for the development and dissemination of conversation aids in diverse clinical settings.

Our recommendations for future development of conversation aids is to use a user-centered participatory approach with all end-users from inception to implementation and sustainability, being mindful of the time it takes to do this successfully with better decisions made. We suggest using the Honeycomb framework in developing and analyzing conversation aids as it provides a useful structure for understanding how end-users perceive and engage with them. We highly recommend keeping conversation aids concise and tailoring them to individual patient’s needs, as this was a major theme highlighted by all stakeholders in the project. Lastly, we recommend incorporating flexibility into a project timeline to allow for continuous adaptations of the conversation aids so they remain useful in an implementation and sustainability context.

Using a user-centered participatory approach to develop a conversation aid from inception to implementation and sustainability takes time and effort. Still, it provides a framework to systematically include all potential end-users and stakeholders. To successfully implement the conversation aids across a broad audience, we learned the importance of providing concise information while offering customization (to both the clinician and patient). Lastly, allowing for continuous adaptations of a conversation aid is important for the usability and acceptability of the tools so they are better sustained in clinical practice.

Availability of data and materials

The dataset analyzed during the current study is not publicly available due to the protection of the human subjects involved in the qualitative interviews. A de-identified copy of the dataset is available from the corresponding author upon reasonable request.

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Acknowledgements

Nancy O’Brien

Jacqueline Pogue

Elaine Kiriakopoulos

Open access funding provided by University of Lausanne The research reported in this manuscript is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (SDM-2017C2-8507). The statements presented in this manuscript are solely the responsibility of the authors and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee.

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Danielle Schubbe, Marie-Anne Durand, Jaclyn Engel, Monica Adams-Foster, Carrie Cahill Mulligan, Tina Foster, Paul J. Barr, Patricia Stephenson, James O’Malley & Glyn Elwyn

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Rachel C. Forcino

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National Uterine Fibroids Foundation, Colorado Springs, CO, 80909, USA

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Contributions

DS: Conceptualization, methodology, formal analysis, investigation, writing - original draft, visualization, project administration; MAD: Conceptualization, methodology, writing - review & editing, supervision, funding acquisition; RF: Formal analysis, writing - review & editing, project administration; JE: Writing - review & editing, project administration; MT: Writing - review & editing, project administration; MA-F: Investigation, writing - review & editing; CB: Investigation, writing - review & editing; CCM: Investigation, writing - review & editing; SV: Investigation, writing - review & editing; TF: Investigation, writing - review & editing; PB: Investigation, writing - review & editing; RA: Investigation, writing - review & editing; SL-T: Investigation, writing - review & editing; AL: Investigation, writing - review & editing; MS: Investigation, writing - review & editing; RG: Investigation, writing - review & editing; PS: Investigation, writing - review & editing; KG: Investigation, writing - review & editing; MA: Investigation, writing - review & editing; TM: Investigation, writing - review & editing; EB: Investigation, writing - review & editing; AG: Investigation, writing - review & editing; JO: Writing - review & editing; MvdM: Conceptualization, methodology, writing - review & editing, supervision; JA: Conceptualization, methodology, writing - review & editing, supervision; GE: Conceptualization, methodology, writing - review & editing, supervision, funding acquisition. All authors read and approved the final manuscript.

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Ethics approval for this study was provided by the Dartmouth Committee for the Protection of Human Subjects on February 1, 2019. Brigham and Women’s Hospital and Montefiore Medical Center provided their authorization agreement to rely on Dartmouth’s approval on May 2, 2019. Ethics approval was provided by Barnes-Jewish Hospital Institutional Review Board on May 10, 2019. The Mayo Clinic provided ethics approval on May 7, 2019. Informed consent was obtained from all human participants.

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Competing interests

Glyn Elwyn has edited and published books that provide royalties on sales by the publishers: the books include Shared Decision Making (Oxford University Press) and Groups (Radcliffe Press). Glyn Elwyn’s academic interests are focused on shared decision making and coproduction. He owns copyright in measures of shared decision making and care integration, namely collaboRATE, integRATE (measure of care integration), consideRATE (patient experience of care in serious illness), coopeRATE (measure of goal setting), toleRATE (clinician attitude to shared decision making), Observer OPTION-5, and Observer OPTION-12 (observer measures of shared decision making). He has in the past provided consultancy for organizations, including: 1) Emmi Solutions, LLC who developed patient decision support tools; 2) National Quality Forum on the certification of decision support tools; 3) Washington State Health Department on the certification of decision support tools; 4) SciMentum LLC, Amsterdam (workshops for shared decision making). He is the Founder and Director of & think LLC, which owns the registered trademark for Option GridsTM patient decision aids; Founder and Director of SHARPNETWORK LLC, a provider of training for shared decision making. He provides advice in the domain of shared decision making and patient decision aids to: 1) Access Community Health Network, Chicago (Adviser to Federally Qualified Medical Centers); 2) EBSCO Health for Option GridsTM patient decision aids (consultant); 3) Bind on Demand Health Insurance (consultant); 4) PatientWisdom Inc (adviser); 5) abridge AI Inc (Chief Clinical Research Scientist). Glyn Elwyn and Marie-Anne Durand have developed the Option Grid conversation aids, which are licensed to EBSCO Health. They receive consulting income from EBSCO Health, and may receive royalties in the future. Marie-Anne Durand was a consultant for ACCESS Community Health Network until 2019. For all other co-authors, no other competing interests are declared.

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Schubbe, D., Durand, MA., Forcino, R.C. et al. Continuous adaptation of conversation aids for uterine fibroids treatment options in a four-year multi-center implementation project. BMC Med Inform Decis Mak 24 , 277 (2024). https://doi.org/10.1186/s12911-024-02637-6

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DOI : https://doi.org/10.1186/s12911-024-02637-6

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Uterine Fibroids - Current Trends and Strategies

Affiliation.

• 1 Department of Women's Health, University of Tübingen, Tübingen, Germany.
• PMID: 30888674

Fibroids are the most common benign tumors in women of childbearing age and can be found in almost 80-90% of all women by age 50 years. They can cause pain, excessive menstrual bleeding or infertility. The development of fibroids increases with age. Since the age of women in industrial countries who are trying to conceive is generally increasing, there has been a growing demand for minimally invasive and uterine-sparing surgical treatment of fibroids. Whereas the main focus of previous surgical techniques for the treatment of fibroids was enucleation of the tumour with subsequent closure of the uterine incision, modern devices developed over the past decade can destroy fibroids by using ultrasound or radio-frequency without incising the uterine wall. Thus, there is no uterine scar, which would impart a risk of rupture during labour or pregnancy. This article provides an overview of the latest techniques and devices used for uterine-sparing surgical treatment of fibroids. While laparoscopic myomectomy is still the gold standard, novel laparoscopic and transcervical radiofrequency ablation techniques use low-voltage and alternating current to induce heat in the uterine tissue, which triggers necrosis in fibroids. This enables the removal of multiple fibroids without the need for large incisions in the uterine wall. In addition, we address the benefits and potential risks, as well as the impact on fertility and pregnancy, of the different surgical approaches used for the treatment of uterine fibroids.

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Dr. Randy Longman Receives NIH Director’s Transformative Research Award

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Dr. Randy Longman. Credit: John Abbott.

Dr. Randy Longman, director of the Jill Roberts Center for Inflammatory Bowel Diseas e and an associate professor of medicine at Weill Cornell Medicine, and colleagues have received the NIH Director’s Transformative Research Award to develop the tools needed to understand how the gut microbiome drives metabolic pathways.

Established in 2009, the award funds innovative but inherently risky research endeavors that have the potential to overturn existing scientific paradigms or create new ones. Part of the High-Risk High Reward Research Program, it helps fund large-scale, unconventional projects that may create new research tools or technologies or develop radically different diagnostic or therapeutic approaches. The award will provide about $5.6 million over five years to Dr. Longman and his co-principal investigators Dr. Aaron Wright , the Schofield Endowed Chair in Biomedical Science and professor at Baylor University, and Dr. Chun-Jun Guo , assistant professor in the Jill Roberts Institute for Research in Inflammatory Bowel Disease at Weill Cornell Medicine.

Dr. Chun-Jun Guo. Credit: Ashley Jones

“The NIH Director’s Transformative Research Award identifies areas in science where there is an unmet need and an opportunity through collaborative science to make transformative breakthroughs,” Dr. Longman said. “It’s an exciting opportunity for three scientists with three distinct scientific programs to come together to accelerate our understanding of the functional impact of gut microbes on human health.”

Dr. Longman is a gastroenterologist and mucosal immunologist focused on understanding the causes of inflammatory bowel disease and developing new treatments. People with the disease have an altered gut microbiome, but the functional effects of these changes or how therapies like dietary changes might alter them are not yet apparent.

“Scientists have studied the microbiome for over a decade with advanced sequencing technologies, and we are very good identifying the microbes that make up the microbiome, genetically sequencing them, and recognizing the metabolites they produce.” Dr. Longman said. “Now, it’s really about connecting the dots between what the microbes are doing and how it affects human health.”

So, Dr. Wright, a chemist who has previously developed chemical probes to study the enzymes and proteins created by soil microbes, will make similar chemical probes that will allow the team to identify and track the source of proteins and enzymes produced by the gut microbiome. Dr. Guo will use his skill in genetically engineering gut microbes to tease apart what the proteins and enzymes do. They will use these techniques to understand the impact of therapies like increased fiber on the microbiome, which Dr. Longman is currently studying in clinical trials with patients with inflammatory bowel disease.

“Our goal is to understand which bacteria have major functional impacts and how we can leverage them to improve disease outcomes,” Dr. Longman said.

For example, Dr. Guo explained, once the chemical probes identify an enzyme of interest in human gut microbe samples, he can genetically engineer gut microbes that don’t produce the enzyme, or make too much of it, to see how that affects the gut in animal models. Guo said that the technology may lead to breakthroughs in treating inflammatory bowel disease and other conditions involving the microbiome.

“If this technology works, we can isolate microbes based on their function,” Dr. Guo said. “If we can then show that some of them are critical to modulating disease severity by reducing inflammation, these microbes could form the basis of a new microbiome-based therapy.”  

This work will be supported by grant number R01AT013241.

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Marie Skłodowska-Curie Actions

Developing talents, advancing research

New call to co-fund Brazilian-EU research partnerships within MSCA Staff Exchanges

The new call will top up selected MSCA Staff Exchanges projects, enabling Brazilian entities to carry out joint research projects with European and international partners and second their staff in Europe.

The Brazilian National Council of State Funding Agencies ( CONFAP ) has published a new call to co-fund projects involving Brazilian entities under the Marie Skłodowska-Curie Actions (MSCA) Staff Exchanges 2024 call . The MSCA are part of Horizon Europe, the EU programme for research and innovation.   

Various Brazilian State Research Support Foundations (FAPs), in cooperation with CONFAP, will top up selected MSCA Staff Exchanges projects, enabling research and innovation organisations in their respective areas to carry out joint research projects with European and international partners. 

The co-funding will allow these organisations to second their staff to European research organisations for training, skills and career development and knowledge sharing.  

The scheme will promote mobility of researchers in both directions and create a balanced flow of exchanges. This will strengthen research ties between Europe and Brazil and drive forward scientific and technological progress by enhancing long-term bilateral institutional cooperation and collaborative research.   

Funding for Brazilian organisations and staff  

Consortia of organisations planning to apply to the 2024 MSCA Staff Exchanges call are strongly encouraged to partner with Brazilian organisations active in research and innovation activities for their proposals.  

An eligible consortium of organisations, including the Brazilian organisations, must submit a project proposal within the deadline through the European Commission’s Funding & Tenders Portal. 

To be eligible for the co-funding, projects should comply with Staff Exchange ’s criteria and include at least one eligible entity based in Brazil.  

In addition, the representatives of Brazilian organisations in these proposals must also submit a summarised proposal to their respective FAP.  

Applicants from Brazil should refer to FAP in their area and participating in the call to check their eligibility. Each foundation will provide guidance on the conditions and rules to be followed by Brazilian organisations applying.   

The full details and guidelines for applicants are available on CONFAP’s website.  

Attend the networking and brokerage event  

If you are looking for new Brazilian partners or are preparing a proposal with other organisations interested in cooperating with Brazil through Staff Exchanges, you can attend the online networking and brokerage event organised by the European Research Executive Agency on 15 November 2024.  

About Staff Exchanges  

Through its Staff Exchanges scheme, the MSCA promote collaborative research, knowledge transfer and innovation through international, inter-sectoral, and interdisciplinary projects. Staff Exchanges support the secondment of research and innovation staff within international consortia of organisations based in the EU, countries associated to Horizon Europe and other countries worldwide.  

The next calls of Staff Exchanges are  

• 2024 call: opened on 19 September 2024, with a deadline on 5 February 2025 
• 2025 call: will open on 27 March 2025, with a deadline on 8 October 2025

Get started with this funding scheme and learn how to prepare a successful proposal.

Timeline for the 2024 call  

• 19 September 2024: launch of the 2024 Staff Exchanges call for proposals 
• 15 November 2024: Staff Exchanges information day and brokerage event  
• 5 February 2025: deadline for applicants to submit proposals at the EU’s Funding & Tenders Opportunities Portal 
• Date TBC: submission of proposals to the participating FAPs 
• July 2025: notification of the call results by the European Commission (TBC) 
• November 2025: signature of the grant agreements with the European Commission and CSIR  
• November 2025: first EU-Brazil - funded projects start (TBC)

More information  

More information and guidelines on the co-funding scheme for interested consortia and Brazilian organisations (in Brazilian Portuguese)  

More information and guidelines on the co-funding scheme for interested consortia and Brazilian organisations (in English)  

Information on how to apply to MSCA Staff Exchanges  

Staff Exchanges 2024 call Guide for applicants  

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Princeton physicist wins physics Nobel Prize for pioneering AI research

An American professor and a British-Canadian professor won the Nobel Prize in Physics on Tuesday for their decadeslong, trailblazing research forming the building blocks of artificial intelligence .

John J. Hopfield, 91, was awarded the honor alongside Geoffrey E. Hinton, 76, who left his job at Google last year so he could speak freely about his concerns over the technology.

The pair are central figures in the creation of modern-day AI .

Since the 1980s, they have been using tools from physics to develop the foundations of what is known as “machine learning,” in which computers are fed masses of data to learn an array of tasks — from diagnosing diseases to knowing people’s favorite streaming shows .

Their research “formed the building blocks of machine learning, that can aid humans in making faster and more reliable decisions ,” Ellen Moons, chair of the Nobel Committee for Physics, told a news conference.

The use of this technology has “become part of our daily lives, for instance in facial recognition and language translation,” Moons said, while warning that AI’s “rapid development has also raised concerns about our future .”

The machine-learning revolution can arguably be traced back to Hopfield, a Chicago-born emeritus professor at Princeton University.

In 1982, he invented the “Hopfield network,” a type of neural network — as these machine-learning programs are known — that was capable of mirroring certain functions of the human brain and recalling “memories” using only partial information.

Hinton is a British-Canadian professor at the University of Toronto who is often referred to as one of the “godfathers of AI.” He used Hopfield’s invention to come up with his own network capable of recognizing shared characteristics among large sets of data. An everyday use for this might be classifying lots of images based on things contained within them.

“I’m in a cheap hotel in California which doesn’t have a good internet or phone connection,” Hinton said Tuesday, quoted by the Royal Swedish Academy of Sciences that announced the prize. “I was going to have an MRI scan today but I’ll have to cancel that!”

He worked for a decade at Google, becoming one of the world’s most renowned voices on AI. He very publicly quit his job last May, posting on X that he made the decision “so that I could talk about the dangers of AI.”

“It is hard to see how you can prevent the bad actors from using it for bad things,” Hinton said in an interview  with The New York Times .

Alexander Smith is a senior reporter for NBC News Digital based in London.