Patients’ average length-of-stay at U.S. hospitals is increasing, jumping 19.2% across the country for patients this year compared to 2019 levels, according to a report released Tuesday by the American Hospital Association. The increase is even greater for patients who are being discharged to post-acute care providers — their average length of stay rose by nearly 24%.
The report showed that hospitals are having a difficult time discharging patients in a timely manner. This is often because there are no available spots for patients who need to be transferred to outpatient facilities, such as centers for skilled nursing or behavioral health.
“Without anywhere safe to discharge these patients, hospitals are left to care for these patients longer than is medically necessary, resulting in added expenses to the hospital and less beds available to meet patient demand, and creating patient bottlenecks,” said Bharath Krishnamurthy, AHA’s director of policy and health analytics. “Also, the data show that patients, on average, are now sicker and more complex to treat compared to pre-pandemic levels which requires some patients to stay in the hospital longer.”
To remedy the increased costs that hospitals are burdened with as a result of this issue, Medicare should establish a temporary per diem payment for cases in which a patient is ready to leave the hospital but is unable to be discharged appropriately, Krishnamurthy declared.
He pointed out that Medicare doesn’t pay hospitals based on the number of days a patient stays in the hospital, but rather pays a fixed amount for each patient based on their illness.
“For example, in an acute care hospital, Medicare pays a predetermined amount based on diagnosis-related groups,” Krishnamurthy said. “Therefore, hospitals bear the burden of added costs associated with the additional days that patients are waiting to be discharged to their next level of care. Given the current workforce challenges, these delays have increased dramatically.”
Under the temporary Medicare per diem payment model that Krishnamurthy has proposed, the hospital would need to demonstrate that they made multiple attempts to contact providers at the next level of care. It would also need to document the reason these providers are not able to admit the patient. This would then trigger a payment, which would “be determined based on per diem methodologies that already exist in the Medicare program,” Krishnamurthy said.
Hospitals are clamoring for these types of interventions from the federal government as providers across the country continue to face extreme financial pressure. Hospitals’ expenses are expected to rise by $135 billion this year, according to Kaufman Hall. The consulting firm also predicted that 68% of hospitals will end the year operating at a financial loss.
“Ensuring that hospitals remain financially stable for the near term means that targeted support is critically needed now to ease the dramatic financial pressures faced by hospitals as a result of these discharge delays,” Krishnamurthy said.
Last week, Nuance added Kentucky-based Baptist Health and Pennsylvania-based Einstein Healthcare to its precision imaging network, a platform that allows healthcare providers to adopt AI-powered diagnostic imaging tools at the point of care.
Nuance, which was acquired by Microsoft last year, produces speech recognition and AI software for healthcare organizations.
Joining the network means that radiologists can deploy AI tools faster and more efficiently, according to Brett Oliver, Baptist’s chief medical information officer. He said the network will help radiologists adopt a broader range of algorithms, which means they will have an easier time figuring out which tools make the biggest impact on patient care.
To an outsider, the amount of time it takes for a health system to adopt a new AI tool might seem “ridiculous,” Oliver said in an interview. This is due to all the vetting that tools must undergo — hospitals must get legal contracts reviewed, ensure that the tool stores data securely, determine its compatibility with various interfaces, and so on.
“One of my colleagues will say, ‘Hey, I saw this product and I really think it can help me with 3D mapping out my brain surgeries. I just think it’s gonna make for better outcomes.’ Traditionally I would have to say ‘Okay, let’s go through the product, see some screenshots and maybe have somebody who’s used it before talk to us.’ It’s a six to nine month process, and it’s expensive,” he said.
More than 12,000 healthcare facilities have joined Nuance’s precision imaging network to speed up that process for physicians. The network is designed to give radiologists and other specialty physicians access to an ecosystem of third-party AI-powered diagnostic tools that they can embed right into their workflows — without having to build and maintain the infrastructure that is otherwise needed to adopt these products. The platform can be integrated into EHRs, Nuance’s PowerScribe reporting product and other clinical systems.
The network was launched about a year ago, and it is powered by the Microsoft Azure cloud platform.
“We’ve got a great relationship with Nuance, and we have PowerShare and PowerScribe already implemented and ready to go. There was very little technical setup to get to this point, and start our process with [the precision imaging network.] But it was really just the platform approach that sold me — we’ve got to be able to plug and play some of these algorithms more readily if we’re going to advance things quickly,” Oliver said.
Baptist is a nine-hospital health system with more than 1,500 providers and a network of more than 2,000 independent physicians. The health system is hoping that joining Nuance’s precision imaging network will improve the accuracy of the treatment it provides to patients, especially those with multiple sclerosis and dementia, Oliver said.
For example, AI imaging tools can look at scans sequentially at the point of care and determine the percentage for which plaque formation is either up or down. This can help neurologists treating dementia or MS make more informed decisions about switching patients’ medications.
It’s important that those types of tools be implemented more broadly in a quick manner, Oliver said adding that the faster the algorithms get implemented, the faster they can start improving clinical quality across the health system.
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Centene Charitable Foundation and Superior HealthPlan — the payer’s subsidiary in Texas — announced Monday that it is investing $7.9 million for a new multipurpose community center in Uvalde, Texas.
The project is in partnership with Community Health Development, Inc. (CHDI), a federally qualified health center in the area. The community center will provide primary medical care, behavioral health care, youth development resources, college and job preparation services for students and retail space for local businesses. It will also have a tranquility garden honoring the 21 victims of the May 24 shooting at Robb Elementary School.
“I’m eager to see the positive impact this new facility can have on this area,” Mark Sanders, CEO of Superior HealthPlan, wrote in an email. “It offers more space for healthcare, opportunities for enhanced technology to better meet the physical and behavioral health needs of Uvalde County, and it will pave the way to better serve students, helping them grow and develop and eventually prepare for college or job training so they can be successful in the next chapter of their lives.”
Executives from Centene, Superior HealthPlan and CHDI held a groundbreaking ceremony for the center on Friday. CHDI is still raising funds for the facility, which will cost $20 million in total, the Uvalde Leader News reported. The building is expected to be completed in late 2024.
Working with federally qualified health centers like CHDI is important to improve health equity, Sanders said. CHDI was founded in 1983 and provides care to about 11,000 people in Uvalde, Real, Edwards and Zavala counties in Texas, according to the provider’s website. Nearly 85% of its patients are at or below 200% of the federal poverty line, almost 47% of its patients are uninsured and over 12% of its patients are covered by Medicaid and the Children’s Health Insurance Program.
“In our experience, these healthcare organizations have deep roots in their local communities, enabling them to bridge social, ethnic and economic gaps to deliver preventive care, dental services, access to mental health care and so much more,” Sanders said.
Centene, Superior HealthPlan and CHDI have been planning the community center since shortly after the shooting at the elementary school took place, according to Sarah London, CEO of St. Louis, Missouri-based Centene.
“Six days after the horrific tragedy at the Robb Elementary School, Centene and Superior met with CHDI and local leaders to understand how we could best support Uvalde in what will necessarily be a long-term recovery,” London said in a news release. “As that process continues, expanding the resources available to the entire community for physical, mental and emotional health is an important step forward.”
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Labor shortages are a global problem, but they matter more in some sectors than in others. In retail, for example, not having enough staff is annoying and stressful; for public health and health care, it can mean lives lost or diminished.
Even before the pandemic, the British medical journal, Lancet, estimated that global health systems were 43 million people short. Now, burnt out by Covid-19, labor gaps threaten to grow to alarming proportions. In 2021, for example, 44 percent of US public-health workers said that they were considering leaving in the next five years. Given that demand for public health services is growing, the labor problem is unlikely to resolve itself.
Every public health system is unique, and the reasons for shortages vary. To respond, leaders can analyze their particular needs and then take action to develop and re-stock the talent pool. But how? Here are four actions that can help.
Support current workersPublic health embodies a noble mission: keeping people alive and well. But to do that, it’s important to promote the wellness and development of those who actually make that mission real. For a start, public-health organizations are known for being hierarchical and bureaucratic—to a fault. A flatter org chart could deliver greater responsiveness and fewer frustrated workers. In addition, employees in all sectors value a statement of expectations. That helps to explain why organizations that clearly set out post-pandemic work arrangements have seen a threefold increase in feelings of inclusionand an almost fivefold increase in feelings of individual productivity. Finally, individuals want to develop their careers—and many are not satisfied with existing options. Think about how to restructure career pathways to make them both clearer and more flexible. Offer ways for people to move laterally, so that they can explore different roles. Identify the needs of different subsegments—laboratory specialists, say, or nurses—and tailor retention initiatives to each type.
Hire and train for future capability needsPresent needs are urgent, but new competencies will be required. Agencies therefore may want to keep in mind how to hire and upskill employees in targeted capability areas to meet evolving public health priorities. For example, the global prevalence of anxiety and depression rose 25 percent in the first year of the pandemic. Public health systems could help fill this need by hiring professionals, creating training programs, and building partnerships with community organizations, academic institutions, and others.
There is also growing demand for data collection and analysis. The pandemic revealed that too many public-health systems didn’t have the information technology (IT) systems needed to capture the data they needed. From a more aspirational perspective, advanced analytics can reveal important insights, such as using syndromic surveillance techniques to spot outbreaks or analyzing environmental and social data to predict risks of lead poisoning or other dangers. This is not just a matter of hiring IT specialists, although that is essential. Public health decision makers—from policy makers to local partners—can also benefit from becoming data literate.
Plan for crisesCovid-19 is a reminder that the unexpected happens — that is why innovation, flexibility, and resilience are critical. One possible approach is to offer training to build up local reserves in less specialized roles who are on “warm standby,” meaning that they can be marshaled at a moment’s notice—as Japan did after the 2011 Tohoku earthquake. For highly specialized roles, national and international organizations could train staff centrally and then deploy them as needed. In terms of existing workers, the goal is to reassess policies to optimize productivity. In an emergency, for example, that could mean establishing emergency thresholds that trigger specific actions, such as temporarily suspending licensing restrictions to allow providers to practice across borders; authorizing pharmacists to prescribe critical medications; or simplifying license renewal processes to bring potential workers out of retirement.
Develop robust talent pipelinesProviders could think of it this way: If they were starting from scratch, how would they go about recruiting candidates? The answer will almost always be, not the way we do it now. The goal, then, is to build streamlined, user-friendly systems that maximize application completion and yield, including leveraging analytically backed digital labor platforms.
Partnerships can be used to great effect. For example, one ministry of immigration in a G-20 country established more than 15 partnerships to attract tech talent, which helped get approximately 100 candidates through its pipeline. Other promising approaches include simplifying job qualifications to emphasize capabilities rather than experience, centralizing public health job listings, ensuring reasonable application turnaround times, providing competitive compensation packages, and offering remote or hybrid work models.
Covid-19 was a terrible human tragedy, costing more than 6.5 million lives. The economic costs are incalculable, but start at $12.5 trillion. Many public-health professionals were little short of heroic, and the case for effective public-health systems was proved. If the lessons of the pandemic are not learned and acted on, however, that would be an additional—and avoidable—tragedy.
By taking these actions, local, national, and global systems could improve their societies for generations to come. That would be a worthy legacy of a terrible time.
According to a HealthSparq survey of 100 hospitals and health systems, 92% of providers want greater collaboration with health plans — believing this will lead to improved patient outcomes and reduced cost of care.
Although payers and providers share the same goal of providing the highest quality of patient care while lowering costs, historically, federal payment models under which providers have been reimbursed for their services haven’t been aligned with those for payers. Thus, this mismatch hasn’t been conducive to helping either side achieve this desired result.
To help both payers and provider organizations to succeed under this new value-based care model, we’ve outlined four strategies below that will help the two sides collaborate better on shared goals.
Strategy #1: Develop a data-sharing strategy.
Providers are primarily responsible for collecting clinical data, which is used to understand the patient’s health status and medical history. By contrast, payers work primarily with patient claims data, which is used for billing. Currently, many health plans share their data with provider groups but do so in their plan-specific formatting. This leaves provider organizations with the job of aggregating data across payers or working with disparate and disjointed data sets.
One method for sharing data more effectively and efficiently is for payers to fold in any of their data into a provider’s existing data-analytics engine. Payers who are willing to work within a provider organization’s data-analytics engine eliminate the administrative burden of aggregating data or working with multiple disparate lists.
Alternatively, a payer-agnostic interoperability solution with a bidirectional pipeline can be used, allowing both parties to upload and share data within a single system. More often than not, the information in a medical chart is more complete and accurate than what is on a claim. Because payers generally only have access to information on a claim, they often request records for risk adjustment chart reviews on an annual basis. Provider groups may be reluctant to accommodate en masse chart requests, but incorporating payer access to medical records via a bidirectional interoperability solution can reduce or eliminate health information management (HIM) teams’ administrative burden in sending charts.
Lastly, data strategy should not be built within a silo. Early on, payers and providers can form a working group of all stakeholders involved — from risk adjustment to quality teams — and create a shared data strategy. As the partnership continues, the group should be flexible, meeting regularly to measure how the strategy is performing and make improvements as needed.
Strategy #2: Create a long-term plan for taking on risk.
Before a provider group even decides to take on risk under a VBC model, payers can implement “triggers” that determine an organization’s readiness for downside risk. One example is a population trigger, which ensures that the size of the group’s population is large enough to sustain a risk-adjusted contract. This is important because if even one beneficiary is extremely high-risk in a very small risk-adjusted patient population, they may have a huge impact on its costs. Another type of trigger is a quality trigger that can demonstrate a provider organization’s ability to execute preventive services and manage chronic conditions, which are key to succeeding under a risk-based contract.
The provider organizations that pass these triggers shouldn’t be expected to take on risk overnight. Many lack experience and knowledge for taking on risk — especially those doing so for the first time. Payers can offer financial incentives for providers to start participating in alternative payment models by starting them off with an upside-only model. Under these contracts, providers only share in savings if they spend below a certain benchmark or budget; if they exceed it, they won’t have to reimburse the payers.
From there, providers can shift to a downside-risk arrangement, under which they still share in savings for meeting or going below costs but must pay reimbursements for exceeding costs. Through this gradual process, small provider groups taking on risk for the first time can be eased into operating under a shared-savings model. Most importantly, they’re given the time to build their own infrastructure needed to succeed independently from the payer.
Strategy #3: Invest in provider-friendly technologies and services.
In addition to creating financial incentives, payers and provider groups can also invest in technologies and services that enhance performance under risk-based contracts. For example, provider organizations can invest in a point-of-care tool, which administrative teams use to examine a patient’s entire medical history before the visit. The tool then gives the clinician a focused “snapshot” of relevant data points, such as suspected conditions that have never been diagnosed and prior year diagnoses that are undocumented. This reduces administrative burden and gives a clinician access to the data at a time when it can be immediately acted upon — when the patient is in the office.
In addition to investing in technologies that fuel concurrent strategies, payers can leverage those that improve retrospective work by outsourcing coding to vendors. By leveraging the power of machine learning and natural language processing (NLP), these vendors can code charts to validate coding at a very high level of accuracy. Furthermore, the right vendor can help with retrospective submission of coding results to the appropriate payers.
Strategy #4: Initiate shared member engagement programs.
To create an opportunity for providers to interact with the beneficiaries they cover directly, payers can partner with their local community’s provider organizations to coordinate events like World Diabetes Day or Annual Wellness Days. In turn, provider groups can also invite payer representatives and educators to sponsor and participate in their community outreach efforts. Through these events, payers and providers can meet face-to-face and maximize the resources available to patients.
Often, providers are unaware of extra benefits their Medicare Advantage patients have included for free in their plans. For example, payers and providers can collaborate on bringing awareness to benefits like transportation, meals after surgery, dental or vision coverage, and Silver Sneakers programs. By implementing these member engagement programs, payers and providers can work together to address social determinants of health (SDOH) issues by better understanding their community’s health needs and increasing access to care.
The future of the payer-provider relationship
Given that providers are under increased pressure from CMS to take on some form of downside risk by 2025, they and health plans can utilize these four strategies to make the transition smoother. And as their payment systems become more aligned, both parties will be able to understand each other better and improve coordination of care.
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he COVID-19 pandemic affected people of all ages and from different walks of life, but just how much did it impact adolescents? In a new study, a team of researchers found that it may have physically altered teens’ brains.For their study, published Thursday in Biological Psychiatry: Global Open Science, the researchers compared the brains of teens before the pandemic (pre-COVID) and after experiencing the pandemic-related shutdowns (peri-COVID).The researchers weren’t initially aiming to make the comparison, according to the news release from Stanford University. Before the pandemic, the researchers were conducting a longitudinal study on the effects of early life stress on adolescents in the San Francisco Bay Area, wherein they were invited for assessments every two years.However, the study — just like most things across the world — came to a halt when the pandemic hit. As such, the researchers then had to have a “hard restart,” study first author, Ian Gotlib of Stanford University, said as per the news release.
This, however, gave them a unique opportunity to look at the impacts of the pandemic on adolescents’ brains.”(I)t is not clear whether youth who lived through the pandemic and its shutdowns are comparable psychobiologically to their age- and sex-matched peers assessed before the pandemic,” the researchers wrote.To find out, the researchers compared the peri- and pre-COVID participants, matching them “as closely as possible” in terms of age and sex.Indeed, they found that the pandemic appeared to have physically altered the adolescents’ brains. Those who experienced the pandemic shutdowns had “reduced cortical thickness, larger hippocampal and amygdala volume, and more advanced brain age.”Their internalizing of mental health problems was also more severe.Although it’s quite natural for people’s brains to change as they age, the results of the scans show that the process appears to have “sped up” in the teens they scanned after the shutdowns. The features in those teens’ brains, researchers say, “are more typical of individuals who are older or who experienced significant adversity in childhood.”According to the researchers, this shows that the pandemic not only affected these young people’s mental health but also affected their brain maturation, with the features indicating “older-appearing brains.”This, they say, is something that researchers conducting longitudinal studies halted by the pandemic may want to take note of.The question now is whether the changes are permanent or merely temporary, Gotlib said, noting that there’s also the question of whether their chronological age will “eventually catch up to their ‘brain age,'” and how this may affect them in the long run.”(I)t is important that we continue to follow and assess individuals who were recruited and assessed prior to the pandemic; this type of research offers the strongest possibility for us to examine the effects of a major stressor experienced on a global scale,” the researchers wrote.
Scientists have created a machine that will listen to your farts, pee, and poop. Yes, that’s right. The machine will recognize and analyze the sound of each bathroom-related activity.The scientists have cleverly named the machine Synthetic Human Acoustic Reproduction Testing machine (S.H.A.R.T.). It is a mechanical device fitted with pumps, nozzles, and tubes. The contraptions are meant to recreate the physics and sound of human bodily functions.The creators of the S.H.A.R.T. machine presented their work at the American Physical Society’s annual Fluid Dynamics conference. Their results are yet to be published in a peer-reviewed journal.Scientists are training AI to detect and scrutinize scatological sounds so that it can one day help in diagnosing deadly diseases like cholera and nip a potential outbreak in the bud.
“There’s an outbreak and resurgence in Haiti as we speak,” Maia Gatlin, an aerospace engineer at the Georgia Tech Research Institute (GTRI), said at the presentation, reported Inverse. Faster detection of cases will help curb outbreaks like these, Gatlin added.The researchers want to use the AI model in tandem with relatively cheap sensors and put them to use in vulnerable regions.“And as we classify those events, we can start to collect that data,” Gatlin said. “It can say, ‘Hey we’re seeing an outbreak of lots of diarrhea.’ Then we can start to quickly diagnose what’s going on in an area.’”Sounds are a non-invasive way to remotely analyze bowel conditions. “Self-reporting is not very reliable,” David Ancalle, a mechanical engineering student at Georgia Tech, said, according to the outlet. “We’re trying to find a non-invasive way where people can get a notification on whether or not they should go get checked out. Like ‘Hey, your urine is not flowing at the rate that it should. Your farts are not sounding the way they should. You should check it out.’”The AI was fed publicly available audio and video of excretions, with frequency spectrum captured of each one of them. The AI was then ready for SHART machine testing.SHART played out different sounds of human outputs with the help of water pumped through the machine. “A lot of thought went into each of the sounds,” Gatlin said. “There was a subsystem for each sound on this little machine.”“It actually performs pretty well,” Gaitlin continued.The AI was able to successfully identify the correct “excretion event” with 98 percent accuracy, according to early data.The scientists are adamant that they want their work to be budget-friendly for everyone.“We’re not trying to come up with million-dollar equipment,” Ancalle said. “We are trying to make this something that can be afforded by just everyone, particularly since the project is focused on urban areas with weak health systems. The affordability aspect is very important for us.”
Data released Wednesday by Blue Cross Blue Shield Massachusetts revealed that mental health visits among its members have increased 100% since 2019. In response, the payer is upgrading its services.
In the third quarter of 2022, BCBS Massachusetts’ members had about 8 million behavioral health visits, compared to about 4 million in 2019. The insurer has expanded its provider network by almost 46% to about 18,000 clinicians in the last five years to meet this demand. To further meet members’ needs, the payer is expanding its primary mental health provider network by contracting with Talkiatry, which provides virtual psychiatric therapy, in-person therapy and medication management, the company recently announced.
Aside from working with Talkiatry, BCBS Massachusetts is also targeting specific conditions and populations by contracting with two specialty mental health provider groups: And Still We Rise and DynamiCare. The former is a provider for marginalized communities, while the latter is a digital therapeutics and coaching company for those battling addiction.
Although mental health was a challenge before the pandemic, Covid-19 escalated the issue, said Dr. Greg Harris, senior medical director of behavioral health at BCBS Massachusetts. It is for this reason that the insurer is ramping up its mental health services.
“We were seeing year over year increases prior to the pandemic and the pace of the increases have gone up dramatically,” Harris said in an interview.
BCBS Massachusetts chose Talkiatry because of its ability to provide support for a variety of ages, needs and preferences, Harris said. The New York City-based company joins several other primary mental health groups in the payers’ network, including Thriveworks, Headway, Refresh Mental Health and Valera Health.
In addition to expanding its primary mental health services, the insurer knew it needed to combat health disparities as well, Harris said. That’s why it chose to work with And Still We Rise and DynamiCare.
“And Still We Rise focuses on diverse populations, that’s their sub-specialty and that’s why we brought that group in,” Harris stated. “DynamiCare we brought in because they focus on a broad range of substance use conditions: alcohol, drugs and tobacco. And they provide a novel treatment model that we couldn’t really get in any other way.”
It already contracts with NOCD for OCD treatment, Forge Health for addiction and trauma support, Aware Recovery Care for addiction treatment and Brightline for family mental health support.
Looking ahead, Harris said BCBS Massachusetts will add additional virtual mental health groups and tackle other specialty areas, such as eating disorders and autism.
“These two areas, autism and eating disorders, are areas of high clinical complexity and sometimes difficulty in finding the right care in real time,” Harris said. “So that’s why those are two priority areas that we’ve really made a commitment to try and solve as soon as possible.”
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Older adults are projected to outnumber kids for the first time in U.S. history by 2034. As our population ages, preparations must be made across industries, fields of study and governments to address its evolving needs, including in clinical trials that set the standards for efficacy and safety of new treatments, especially in cancer. Ageism is an often-overlooked health inequity widely prevalent in cancer clinical research. Despite the fact that cancer is a disease of aging (42% of people with cancer are at least 70 years old), studies show that older patients comprise only 24% of participants in cancer trials.
Equitable representation in trials improves our understanding of a drug’s benefit-risk profile for patients who will ultimately receive treatment. This is especially true for cancer drugs, because differences may exist between younger and older adult patients in drug response and toxicity due to age-related physiologic changes. Today, almost everything we know about cancer therapeutics is based on trials conducted in younger patients, who also have fewer functional or cognitive impairments and/or co-morbidities than older patients.
Recognizing the urgency of addressing this issue, the U.S. Food and Drug Administration (FDA) issued new guidance in March 2022 that recommended “including an adequate representation of older adults in cancer clinical trials.” It also emphasized “the particular importance of including adults over the age of 75,” who represent a growing segment of the cancer patient population and a growing proportion of the global population.
The roots of this problem are deeply embedded in the systemic clinical trial infrastructure, regulatory requirements, and standard practices, all of which will need to be overhauled in the coming years as the population ages. In the meantime, those of us involved in cancer drug development, research, treatment, patient care and advocacy should evaluate which structural barriers can be navigated around to increase participation of older patients in clinical trials at present. Here are four actions we can take now:
Educate and engage patients and referring providers
According to the National Institutes of Health, a principal challenge of recruiting participants is the lack of awareness and education about clinical trials, availability and how to participate. In a nationwide survey, 80% of patients with cancer did not consider the possibility of participating in a treatment clinical trial because they were unaware that this was an option. This lack of awareness is anticipated to exacerbate in older adults as use of digital technology pervades clinical research and recruitment.
The cancer community must step up its efforts to educate and engage patients, site coordinators, patient advocates and caregivers about clinical trial protocols and participation. Educating referring physicians is an especially important, yet overlooked, way to increase enrollment of older adults in cancer clinical trials, as studies have shown that lack of primary care provider support is a key deterrent to clinical trial participation.
Re-evaluate eligibility criteria
The protocols for many cancer trials explicitly exclude a significant portion of older and frail adults because of their medical histories and co-morbidities. In a recent systemic review, researchers identified stringent eligibility criteria as a major barrier to older adult access to available trials.
Eligibility criteria should be re-evaluated to ensure the reason for excluding these patients is based on strong clinical or scientific evidence. When creating these criteria, researchers should consider how they align with the physical and cognitive capabilities and medical conditions of those most likely to take the approved drugs. According to the new FDA guidance, trial sponsors should consider getting input on trial design, trial conduct and recruitment strategies from geriatricians, geriatric oncologists, and social and behavioral scientists. A study on barriers to participation recommended that “Protocol designs need to stratify for age and be less restrictive with respect to exclusions on functional status, comorbidity and previous cancers.”
Bring research to the trial participants
Even when older patients do meet enrollment criteria, many do not want to participate in clinical trials because of transportation issues, time demands, and cost constraints. An obvious solution emerged during the Covid-19 pandemic – using technology to bring healthcare to the patient. “Telehealth” has become a new norm and the popularity of decentralized clinical trials skyrocketed after Covid-19.
The FDA Oncology Center of Excellence (OCE) supports the decentralization of clinical trials through the remote collection of trial data outside of standard in-person trial sites. Such methods can include: electronic informed consent, delivery of investigational product to the home, virtual clinic visits in patients’ homes for monitoring and data collection, and obtaining laboratory or imaging assessments locally. Decentralizing burdensome aspects of trials will remove obstacles to patient enrollment and participation, while providing healthcare providers real-time data.
Design trials that focus solely on geriatric patients
Perhaps the most effective approach to increase enrollment of older adults is to conduct trials specifically for older adults. Studies confined to older patients can address questions of particular interest to older adults (e.g., preservation of function) and increase our knowledge of tumor biology and the effect of comorbid conditions in the geriatric oncology patient population.
For example, because age is the major risk factor for breast cancer, one study for women with early-stage breast cancer who were 65 years of age or older found that standard adjuvant chemotherapy was superior to a monochemotherapy. Other studies are underway to assess the efficacy and tolerability of new drugs 1) in unfit and frail participants 80 years and older with previously untreated diffuse large B-cell lymphoma, and, 2) as an adjuvant alternative to chemotherapy in patients with high risk breast cancer 70 years and older.
People are living longer and this growing patient population needs innovative treatments tailored to the needs of aging bodies, which is why clinical research must include elderly patients. A Cancer and Aging Research Group conference report says it well: “Older age alone should not be a contraindication to clinical trial enrollment.” While the barriers to inclusivity are complex and multifaceted, it’s long past time to tear them down and develop new approaches to research that will lead to evidence-based care for geriatric patients with cancer.
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More than 500 million people on the planet have chronic lung disease — all eager for better therapies. Unfortunately, the wait for novel treatment is a long and expensive one — it takes 14 years and more than $1 billion, with a failure rate of 95%, to get a single drug from research labs to pharmacies.
Many of the issues that contribute to these high-cost failures and delays in clinical trials have something in common: poor data. Here are two examples:
Weak endpoints – Common tests used to assess treatment response, such as the six-minute walk test, are often indirect measures of lung health, are insensitive, or both.
Poor data quality – Data quality issues can occur in data acquisition, transcription, storage, and more. To measure the impact of a drug, it is critical that the collection of data from time point to time point is consistent and comparable.
Because of weak endpoints and poor data quality, clinical trials require large population cohorts to show a statistically significant therapy impact. This drives high cost and long timelines.
Good news
There is good news for those 500 million patients with lung disease. We are in the midst of a lung intelligence revolution that is vastly improving the efficiency of clinical trials by addressing the underlying issue of poor data. The combination of rich imaging data, called an “imaging biobank,” with advances in artificial intelligence (AI) is a powerful tandem.
With lung intelligence, trials don’t need to rely on weak endpoints. Sponsors are increasingly leveraging imaging biomarkers that deliver direct and precise measures of a therapy’s impact on lung structure and function. Now that sponsors can measure sub-millimeter changes to airway walls, for example, the impact of a therapy can be seen much quicker and with fewer subjects compared to conventional measures (e.g. exacerbations, death, or a six-minute walk test).
While precision imaging biomarkers are incredibly powerful, there has been a hurdle for trial sites to overcome. Collecting high resolution, consistent imaging data can be more challenging than administering conventional tests such as patient surveys. For example, CT scanners must be calibrated at regular intervals, patients must be coached on breath holds, and other elements of a trial protocol must be followed carefully to ensure high quality data.
Cloud services, AI, and refined data: A powerful trio
Across life sciences and healthcare, the ability to capture, share and analyze data in the cloud has transformed drug discovery and clinical trials. With that cloud infrastructure, the transformative value of lung intelligence truly shines.
Cloud-based portals now orchestrate imaging operations for clinical trial sites, allowing staff to easily overcome the hurdle of executing precision clinical trial imaging. For example:
AI-powered services perform quality control checks and can intervene instantly to prevent poor data from entering the system.
Reminders are issued to sites at appropriate intervals for scanner calibration, with step-by-step guidance.
Staff training is conducted through portal-based eLearning modules, with certification status maintained centrally.
Data management, including auto-anonymization, secure exchange, and data organization is now managed effortlessly and centrally by cloud technologies.
Imaging biobanks and operational data is available in the cloud for high-value analysis, such as retrospective analyses that could identify candidates for future trials.
Sponsors have real-time trial business intelligence dashboards to monitor the health of their trial sites, data quality, and overall trial operations.
The combination of cloud and AI/imaging-related biomarkers has dramatically reduced the friction historically caused by sponsors introducing imaging endpoints to a trial. Cloud services put AI-generated biomarkers just a few clicks away. Now, for trial sponsors who want to capitalize on the significant benefits of bringing imaging into their respiratory clinical trial, operational complexity for sites is no longer a time or cost barrier. Furthermore, sponsors can be confident in the quality of the data that will be collected by cloud-enabled sites.
Decentralized trial imaging
Now that cloud portal technologies are removing friction from imaging-based clinical trials, an interesting beneficiary has emerged: independent imaging centers. These centers traditionally have not participated in clinical trial imaging, largely due to the complexity that was involved. As a result, trials have been centralized, often at large academic centers. With cloud-based trial platforms enabling a broader set of sites, we are seeing radiology imaging groups embrace clinical trials, which expands access to patients and diversifies trial populations. The concept of decentralized clinical trials—trials that allow for data collection outside of large medical centers—is now becoming a reality even for trials that involve advanced imaging.
A bright future
Thanks to the convergence of cloud technologies, AI, and refined lung data, we are in a new era for those with chronic lung disease. In this new world, lung intelligence provides fast, precision measures of treatment efficacy so new drugs can blaze through the trial pipeline. Trial sites can now conduct precision imaging with ease, collecting pristine data for sponsors. Imaging data can be collected in hundreds of locations in both urban and rural areas to foster diverse trial cohorts.
The biggest winners in this new era are patients with chronic lung diseases. Clinical trials are more accessible and new life-extending therapies are finding their way to pharmacies faster.
After seeing how quickly the healthcare community could introduce new vaccines to market for Covid-19, there’s a renewed sense of enthusiasm for innovations that accelerate timelines. This enthusiasm, combined with lung intelligence, gives hope for a bright future of fast, efficient, clinical trials.
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