Dr. Joel Ross Explains Why Older Adults Are Missing From Drug Trials

Walk into almost any geriatric practice, and the waiting room usually tells a story that clinical trial data often does not. The patients are in their 70s, 80s, and 90s. Many take five or more medications, manage several chronic conditions, and arrive with a spouse or adult child who typically handles the driving.

These patients are likely to be prescribed newly approved drugs, yet people like them are often underrepresented in the studies that got those drugs approved.

Dr. Joel Ross has spent more than 35 years working inside that care gap. A New Jersey geriatrician and clinical researcher, he has served as a principal investigator or co-investigator on 140 clinical trials, with experience ranging from trial design and execution to patient enrollment and retention. That experience gives him a clear view of why older adults so often go missing from clinical trial data and what it would take to bring them into the fold.

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The People Taking the Drugs Are Not the People Testing Them

The United States is aging quickly. Census Bureau estimates released in 2025 put the population age 65 and older at 61.2 million. Those estimates also showed that older adults outnumbered children in 11 states and nearly half of all U.S. counties. Older Americans account for a large share of the country's medication use, too. According to the Centers for Disease Control and Prevention, about one-third of adults in their 60s and 70s used five or more prescription drugs over 30 days.

Unfortunately, clinical trial enrollment hasn't kept pace with that data. An FDA analysis presented at the American Society of Clinical Oncology's 2017 annual meeting found that adults 65 and older made up about 40 percent of cancer trial participants, even though they represented more than 60 percent of people with cancer. The gap only widened with age. Patients 75 and older accounted for 37 percent of people with lung cancer but only 9 percent of lung cancer trial participants. For colon cancer, the figures were 33 percent and 8 percent. For breast cancer, they were 19 percent and 4 percent.

The problem isn't limited to oncology. A 2026 study in the Journal of Clinical Epidemiology reviewed 207 COVID-19 vaccine trials and found that only 9 percent of the more than 700,000 participants were 65 or older. The study also noted that this age group made up 18 percent of the U.S. population and accounted for 76 percent of COVID-19 deaths.

Exclusion Criteria Do Most of the Work

Explicit upper age limits get the attention, but they're only part of the story. In the COVID-19 vaccine analysis, just 35 percent of studies set a maximum age. Far more common were exclusions for conditions such as hypertension, diabetes, and cancer, all of which are more prevalent in older adults. Trials that used those exclusions tended to enroll younger participants, even without an upper age limit.

The same pattern shows up in Alzheimer's research, where older adults make up much of the patient population. In a 2023 analysis published in Neurology, Mayo Clinic researchers applied the lecanemab trial's criteria to 237 people with mild cognitive impairment or mild dementia and evidence of amyloid buildup, drawn from a population-based study. About 47 percent met the inclusion criteria. Once exclusions such as a history of stroke, cardiovascular disease, cancer, and certain brain imaging findings were applied, only 8 percent remained eligible.

For Dr. Joel Ross, who completed his geriatric medicine fellowship at Mount Sinai Medical Center under Dr. Robert N. Butler, the first director of the National Institute on Aging, that result reflects something geriatricians see every day. Older patients rarely arrive with a single, isolated diagnosis. Kidney function may decline. Heart rhythms can change. Medication lists grow. A protocol that screens out each of those factors can end up studying a healthier, younger group than the one that will eventually use the drug.

Why Sponsors Keep Designing Narrow Trials

Trial sponsors have understandable reasons for choosing narrow study populations. A study that enrolls participants with fewer health problems can make the results easier to interpret. There may be fewer adverse events unrelated to the drug and fewer participants who drop out. A drug's effects can be easier to detect, and timelines can be easier to predict. For a company investing heavily in a single compound, those advantages are hard to ignore.

The trade-off becomes clear after approval, when a physician has to decide how a drug will behave in an 82-year-old with heart failure, reduced kidney function, and a long medication list. Dosing, drug interactions, and side effect rates observed in healthier participants may not apply in the same way. Clinicians are left making judgments with limited evidence, and patients face the uncertainty.

Ross has approached this problem from both sides of the research process. Through the Memory Enhancement Center of America, which he founded in 2000, his team took part in clinical trials for oral and transdermal Alzheimer's medications that are now approved. As founder and CEO of J&D Pharmaceuticals, he also works on the development side, advancing investigational compounds that the FDA hasn't approved. Across both roles, his work has focused on whether research produces better health outcomes for older adults in everyday clinical care.

The Practical Barriers Nobody Writes Into the Protocol

Even when older adults qualify, the demands of participating can shut them out. Trials often require frequent site visits with long appointments for infusions, imaging, blood draws, and cognitive testing. For a patient who no longer drives, each visit may depend on a family member taking time off work. Mobility problems, hearing or vision loss, and unfamiliarity with electronic diaries or app-based check-ins can make participation even harder.

Recruitment has its own blind spots. Many trials recruit through academic medical centers, while many older adults receive their care from community physicians who may not know which studies are enrolling. Investigators may also hesitate to approach frail patients, assuming they won't tolerate the protocol or will leave early.

These are the kinds of problems a principal investigator can see long before they appear in a published paper. Dr. Joel Ross wrote a primer for investigators titled "PI: Principal Investigator or Practically Invisible?" and served as a trustee of the Association of Clinical Research Professionals. The title points to the importance of staying involved in a study's day-to-day work. Investigators who stay engaged are better placed to answer questions, spot problems, and help participants stay involved.

Policy Is Starting to Push in the Right Direction

Regulators have recognized the gap for years. The National Institutes of Health's Inclusion Across the Lifespan policy, which took effect in January 2019, requires researchers conducting NIH-funded human subjects research to include people of all ages unless there's a scientific or ethical reason not to, and to justify age-based exclusions.

In December 2025, the FDA finalized guidance titled Enhancing Participation in Clinical Trials: Eligibility Criteria, Enrollment Practices, and Trial Designs. The guidance notes that gaps remain among older adults and patients with multiple health conditions. It cautions sponsors against automatically excluding these patients without clinical justification and encourages approaches such as fewer study visits, remote assessments, and electronic consent.

Guidance alone doesn't enroll patients, though. Much of the work happens at the site level, where coordinators and investigators consider how flexible a visit schedule can be, whether transportation help is available, and whether an exclusion is necessary for patient safety.

What More Inclusive Trials Would Look Like

Closing the gap starts with eligibility criteria based on the drug's risks and how it works. For example, researchers can consider whether the drug's safety profile justifies a kidney function cutoff and how the body processes it. Patients with stable, well-managed chronic conditions may be able to participate with appropriate monitoring.

Participation also has to be easier. Home visits, telehealth check-ins, flexible visit windows, and transportation support can lower the burden on patients and caregivers. Partnering with community practices and geriatric clinics brings studies to where older adults already receive care.

Trials should also measure what matters to older patients and report it clearly. Outcomes such as independence, fall risk, cognitive function, and quality of life belong alongside standard measures of how well a treatment works. Reporting results separately for participants 75 and older can also reveal differences that a single 65-plus category might hide.

This emphasis on the whole patient runs through Ross's career. He became the first geriatrician to practice in New Jersey. He built the state's first geriatric fellowship program, spending years training physicians in geriatric care who went on to practice across the country. For Dr. Joel Ross, the lesson from decades at the bedside and in the research clinic is simple: if a drug will be used mostly by older adults, older adults belong in the trial.

About Dr. Joel Ross

Dr. Joel Ross is a New Jersey geriatrician, clinical researcher, educator, and author with nearly four decades in medicine. He earned his medical degree from Downstate Medical Center and completed his geriatric medicine fellowship at Mount Sinai Medical Center. He served as the first Medical Director of the Anna Alexander Greenwall Geriatric Program at Monmouth Medical Center, where he was named Teacher of the Year. He later directed the geriatrics section of the Department of Internal Medicine at 

Jersey Shore Medical Center

His clinical work has centered on diagnosing and treating conditions associated with aging, including cognitive disorders, with an approach built on careful evaluation, evidence-based treatment, and respect for patient dignity. He founded and leads J&D Pharmaceuticals LLC in Monmouth, New Jersey, and volunteers at Parker Health Center in Red Bank, where he provides free care to older patients.

This is a guest blog entry.

When Are Mounjaro Sulfur Burps Normal and When Are They a Warning Sign?

Sulfur burps on Mounjaro catch almost everyone off guard. You start a medication prescribed to control blood sugar or support weight loss, and within days you're dealing with a smell that belongs in a biology lab - not at the dinner table. It's uncomfortable, occasionally alarming, and confusing enough that plenty of people wonder whether to stop their dose, call their doctor, or just wait it out. The honest answer depends on what's going on alongside the burps. Mounjaro sulfur burps are a documented side effect, and most of the time they're not dangerous. But certain symptom combinations - paired with those rotten-egg belches, genuinely need medical attention. Knowing the line between "my body's adjusting" and "this is a red flag" is the most useful thing you can take from this article.

Why Mounjaro Causes Sulfur Burps in the First Place

Tirzepatide - the active ingredient in Mounjaro - slows gastric emptying significantly. That's part of how it works. Food lingers in the stomach longer, and that delayed transit gives gut bacteria more time to ferment sulfur-containing compounds in what you eat. The byproduct is hydrogen sulfide gas, which is responsible for the characteristic rotten-egg smell. If you've been researching Mounjaro sulphur burps and wondering why nearly every account describes the same odor, that's your answer - it's the same gas no matter what you ate. High-sulfur foods speed the process up, but even a modest meal can set off burps during the early weeks. The mechanism isn't a malfunction. Your digestive system is simply running slower, and sulfur fermentation is a predictable consequence of that slowdown - context that changes how you interpret what your body is doing.

How GLP-1 Receptor Agonists Slow Digestion

Mounjaro is a dual GIP and GLP-1 receptor agonist, and one of its effects is a gastroparesis-like slowing of the stomach. Gastric emptying that normally takes two to four hours can stretch to six or longer in some patients. In a 2023 review published in Gastroenterology, researchers at the University of Michigan documented gastric retention in GLP-1 users, noting the effect is most pronounced during the first several weeks of treatment and after each dose increase. That's relevant to sulfur burps because the longer food sits in the stomach, the more fermentation takes place. Proteins from eggs, meat, legumes, and cruciferous vegetables are especially sulfur-rich, and bacterial breakdown of those proteins is what generates hydrogen sulfide. The burps signal that the drug is active, not that something's gone wrong. Most patients notice the worst episodes within 24 to 48 hours of each weekly injection, which lines up exactly with peak drug concentration in the bloodstream.

What Normal Sulfur Burps Look and Feel Like

Normal sulfur burps on Mounjaro follow a recognizable pattern, and once you know what to expect, they're much easier to distinguish from something more serious. They tend to appear within the first day or two after your injection. They smell strongly of sulfur or rotten eggs. They may come with mild nausea, some bloating, or a feeling of fullness that won't budge, all of which are also standard GI side effects of tirzepatide. The important thing here is mild. You should still be able to drink fluids, eat small amounts, and function during your day, even if you feel off. The burps typically ease up as your dose cycle winds down, then return when you inject again. You might also notice them settle down over several months as your body adjusts to the drug. If that pattern describes what you're going through, you're most likely in normal-adjustment territory. Discomfort is real, but it's not the same as danger.

When Sulfur Burps Cross Into Warning-Sign Territory

Not every case of Mounjaro-related sulfur burps stays in "normal adjustment" territory. Some symptom combinations point to complications that need a doctor's input, and spotting them early matters. The GI effects of tirzepatide can occasionally tip into pancreatitis, severe gastroparesis, or a worsening of an underlying condition. None of those are common, but they do happen, and they share early symptoms with garden-variety indigestion. The difference usually shows up in severity, duration, and what else your body is doing at the same time. Sulfur burps that arrive alongside localized pain, high fever, or persistent vomiting aren't typical drug adjustment, they're a signal that something else is happening and your GI tract needs a closer look.

Symptoms That Signal a Bigger Problem

Certain symptoms paired with sulfur burps should prompt a call to your doctor the same day - or a trip to urgent care if they're severe. Watch for these:

•  Severe or persistent abdominal pain - especially pain that radiates to your back or upper left abdomen, which can indicate pancreatitis
• Vomiting that doesn't stop - unable to keep down any liquids for more than a few hours
• Fever above 101°F - not typical for a GI side effect and suggests infection or inflammation
• Dark or tarry stools - a sign of bleeding somewhere in the GI tract
• Jaundice - yellowing of the skin or eyes, which points to liver or gallbladder involvement
• Severe dehydration - dry mouth, no urination, dizziness when standing

Mounjaro carries an FDA-mandated warning for pancreatitis, and its early symptoms overlap significantly with bad indigestion. The FDA's 2023 prescribing information for tirzepatide explicitly advises discontinuing the drug if pancreatitis is suspected. Don't wait to see if it improves on its own.

How Long Is Too Long Before You Call Your Doctor

Mild sulfur burps that stay mild, no fever, no severe pain, no vomiting you can't manage, can reasonably be monitored at home for a week or two, especially in the first few months on Mounjaro. But duration matters. Burps that persist past two weeks without any improvement, or that get worse rather than better after a dose adjustment, deserve a conversation with your prescribing provider. Your doctor may want to rule out small intestinal bacterial overgrowth (SIBO), which can develop or worsen in people with slowed motility, and which produces exactly the same symptom profile as normal Mounjaro GI effects. SIBO is treatable, but it won't resolve on its own. If your symptoms follow the weekly injection cycle closely and ease up by day five or six, you're likely looking at normal drug pharmacokinetics. If they run continuously without any pattern, get that checked.

Practical Ways to Reduce Sulfur Burps on Mounjaro

You don't have to simply endure the sulfur burps and wait for your body to adjust, though adjustment does happen for most people over time. Several diet and timing strategies make a real difference, and they don't require any special products or supplements.

Diet and Timing Adjustments That Actually Help 

The single most effective change is cutting back on high-sulfur foods in the 24 to 48 hours after your injection, since that's your peak-symptom window. High-sulfur foods include eggs, red meat, garlic, onions, cruciferous vegetables (broccoli, cauliflower, cabbage), and beer or wine. You don't need to cut them permanently - just dial them back around injection day. Eating smaller, more frequent meals during that window also reduces the fermentation load, since less food sits in a slowed stomach at any one time. Stay upright for at least an hour after eating so gas can move through rather than pool at the gastric level. Some patients find peppermint tea or simethicone eases the bloating that tends to accompany the burps, though neither targets the root cause. Sipping water consistently throughout the day - rather than drinking large amounts at once, also supports motility without overwhelming a stomach that's already sluggish.

Conclusion

Mounjaro sulfur burps are among the more unpleasant side effects of tirzepatide, but for most patients they're a sign the drug is working rather than a sign of harm. What matters is what comes with them. Burps arriving a day or two after injection, feeling mild to moderate, and easing on their own fit the normal adjustment pattern. But sulfur burps paired with severe abdominal pain, persistent vomiting, fever, or signs of dehydration need prompt medical attention. Diet adjustments during your peak-symptom window can meaningfully cut the frequency and intensity of episodes. And if the burps run continuously without any weekly pattern - or if they're getting worse rather than better after two months on the medication - bring that up with your prescribing provider. A conversation early is almost always better than waiting to see how bad it gets.

This is a gust blog entry.

Streamlining Healthcare Systems for Better Efficiency

Health care is one of the most complex industries in the world to run. A single hospital can involve thousands of employees, hundreds of workflows, layers of regulation, and life-or-death stakes attached to nearly every decision. Multiply that across a regional system with dozens of facilities, and the challenge becomes enormous. In that environment, efficiency is not about cutting corners. It is about removing friction so that clinicians can spend more time with patients and less time fighting the system around them.

Few executives have tackled that challenge with as much consistency as Jim Sheets, a health care leader whose nearly three decades in the field have focused on making large, sprawling organizations run more smoothly. His track record shows what happens when someone treats operational efficiency not as a cost-cutting exercise but as a way to improve care, strengthen finances, and support the people doing the work. 

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Efficiency Is a Patient Issue, Not Just a Budget Issue

It is tempting to think of efficiency as a purely financial concern. In reality, waste in a health system almost always reaches the patient. Duplicated tests, slow handoffs, disconnected technology, and tangled workflows all translate into delays, higher costs, and frustration for the people receiving the care and caregivers delivering the care.

The best operators understand this. When Jim Sheets approaches a struggling operation, the goal is rarely just a healthier balance sheet. It is a system where resources flow to where they matter most. During his time leading the Peaks Region for Intermountain Health, he built a multi-year operational improvement plan that produced meaningful financial gains in its very first year while holding patient satisfaction steady through a period of intense change. The region also raised its quality and safety scores at the same time. That is the mark of true efficiency. Quality, experience, and margins all move in the same direction.

Lesson One: Consolidate What Is Scattered

One of the most common sources of waste in a large health system is fragmentation. Programs grow in different corners of the organization, each with its own branding, technology, and processes. The result is confusion for patients and duplicated effort for staff.

A major theme in the career of healthcare executive Jim Sheets has been pulling scattered pieces into a single, coherent whole. As Vice President of Telehealth and Outreach Services, he inherited a virtual care program stretched across eight states. Rather than let it stay fragmented, he rebuilt the offering from the branding up and consolidated it into one modern hub, then grew its volume year after year.

That consolidation became one of the most important operational decisions of the era. When the pandemic forced in-person care to pause almost overnight, the unified platform allowed his team to scale video visits by a factor of a thousand and launch new virtual programs across behavioral health, remote monitoring, and oncology. A streamlined system was ready to surge precisely because someone had done the unglamorous work of simplifying it in advance.

Lesson Two: Integrate Acquisitions the Right Way

Growth through acquisition can either strengthen a system or bog it down. Bolting on new facilities without a plan to integrate them creates redundancy, culture clashes, and operational drag. Done well, integration expands capacity while keeping the organization lean.

Here again, the work of Jim Sheets offers a clear model. As Chief Operating Officer for Acute Care Services in Intermountain's Canyons Region, he identified, negotiated, and integrated the acquisition of an air medical company, folding it into the existing Life Flight service to create one stronger air ambulance operation rather than two competing ones. That is integration that reduces complexity instead of adding it. 

He applied the same discipline at scale between his chapters at Intermountain, when he served as Group President for the Mountain Region of CommonSpirit Health. Leading the organization's entry into Utah, he integrated five acute care facilities in a matter of months while aligning leadership teams with the culture of a faith-based system. Moving that quickly without creating chaos requires a leader who knows how to standardize processes and eliminate duplication as facilities come together.

Lesson Three: Build Structures That Reduce Redundancy

Efficient systems are usually well-organized systems. When responsibilities are clear and specialized functions are grouped logically, the whole operation moves faster and makes fewer mistakes.

In the Canyons Region, Jim Sheets oversaw acute operations across 21 hospitals in Utah and Idaho, along with the system's surgery centers, telehealth, air ambulance, and outreach services. Managing that breadth required deliberate structure. He stood up a dedicated ambulatory surgery center division, giving that line of service the focus and accountability it needed rather than leaving it buried inside a larger department. Under his leadership, the region reached the top tier of national quality rankings, exceeded its financial targets, and saw caregiver engagement and safety culture climb.

Creating clear divisions and clear ownership is not bureaucracy for its own sake. It is how a leader keeps a huge organization from tripping over itself, so that each unit can be measured, improved, and held to a standard.

Lesson Four: Modernize the Physical Footprint

Efficiency is not only about workflows and org charts. It also lives in buildings, equipment, and facilities. Aging infrastructure quietly drains resources through higher maintenance costs, wasted space, and outdated design.

Throughout his career, Jim Sheets has paired process improvement with disciplined facility work. In the Canyons Region, he opened a new community hospital in one of Utah's fastest-growing areas and launched a long-range plan to modernize the system's flagship facilities. Earlier, while leading LDS Hospital in Salt Lake City as CEO and Administrator, he delivered a major facility renovation on time and under budget and secured philanthropic funding for a new blood cancer clinic. That same turnaround saw patient satisfaction climb into the top tenth percentile nationally and the hospital's finances improve by tens of millions of dollars.

Delivering large projects on schedule and on budget is itself a form of efficiency. It signals an organization that plans carefully and executes with discipline.

Efficiency in Service of People

Pull these threads together, and a philosophy emerges. Consolidate what is fragmented. Integrate growth without adding drag. Build clear structures. Modernize the physical footprint. Each step removes waste, and each one ultimately serves patients and caregivers rather than an abstract bottom line.

That is the quiet consistency running through the career of Jim Sheets. Whether the setting was a single hospital, a multi-state telehealth network, or an entire regional system, the aim stayed the same. Make the organization simpler to operate so that its people can focus on care. The financial gains, quality improvements, and satisfaction scores followed as a result of that focus, not in place of it.

Streamlining a health care system is difficult, patient work that rarely makes headlines. But when it is done well, everyone benefits. Staff spend less time on friction, organizations spend resources more wisely, and patients receive faster, safer, and more coordinated care. Efficient systems are, in the end, more humane ones, and building them is a leadership skill worth recognizing. 

This is a guest blog entry. 

IV Hydration Therapy: What Patients Should Know

Walk into most strip malls today and you will likely spot a sign for IV hydration therapy. These clinics have opened in cities of every size over the past several years. Patients stop in for a drip during a lunch break or after a rough weekend.

The service looks simple from the outside: a needle, a bag of fluids, and forty-five minutes in a recliner. Behind that simplicity sits a layer of medical oversight most patients never think about. Every clinic offering IV therapy needs a medical director for iv hydration to meet state medical board rules.

What IV Hydration Therapy Actually Involves

IV hydration therapy delivers fluids, electrolytes, and sometimes vitamins directly into the bloodstream. A needle connects to a bag through a thin tube, and the fluid drips in over thirty to sixty minutes. This route skips the digestive system entirely.

Clinics often market blends for hangovers, jet lag, athletic recovery, or general wellness. Some add vitamin C, B complex, or magnesium to the base saline solution. The exact mix varies widely from one clinic to the next.

The appeal is speed. Oral rehydration takes hours to work through the gut, while IV fluids reach the bloodstream almost immediately. That immediacy is part of why the service has grown so quickly in recent years.

Common Ingredients In A Typical Bag

Most drips build from a saline or lactated Ringer's base. Clinics then add extras based on the package a patient chooses. A few frequent additions include:

• B vitamins for energy support
• Vitamin C for general wellness claims
• Magnesium or zinc for muscle and immune support
• Anti-nausea medication for hangover specific blends

Who Typically Seeks This Service

Patients range from athletes managing dehydration to office workers looking for a quick energy boost. Some arrive after a stomach virus left them unable to keep fluids down. Others simply want a preventive option before a busy week.

Why Medical Oversight Is Required

IV therapy involves inserting a needle into a vein and infusing substances that bypass normal digestion. That makes it a medical procedure, not a spa treatment, even when the setting feels casual. Most states classify it under nursing or medical practice acts.

Because of that classification, nurse practitioners running these clinics generally need a collaborating or supervising physician on record. The specific requirement depends on the state's scope of practice laws for NPs and PAs. Skipping this step can put both the clinic and the patient at risk.

The Centers for Disease Control and Prevention has noted that any injectable or infused product carries infection control risks if protocols are not followed closely. That guidance applies directly to IV hydration bars, where staff insert needles dozens of times a day. Proper oversight includes reviewing sanitation and dosing protocols, not just signing paperwork.

How Clinics Find A Qualified Collaborating Physician

Finding a physician willing to provide this oversight used to take months of networking. Clinic owners called colleagues, posted in professional groups, or waited on referrals that never came through. That delay often pushed opening dates back significantly.

Physician matching services now shorten that timeline considerably. These services connect NP and PA led clinics with state licensed physicians who understand the specific requirements for infusion based practices. Some can complete a match within a couple of days rather than months.

A good match involves more than a signature on a contract. The collaborating physician should understand IV therapy protocols, review clinical documentation periodically, and remain reachable if a question comes up. Clinics should confirm these details before finalizing any agreement.

Questions Patients Can Ask Before Booking

Patients rarely ask about a clinic's medical oversight, but a few questions can reveal a lot. Asking who supervises the clinic clinically is a reasonable starting point. A clinic that cannot answer clearly may not have proper oversight in place.

Other useful questions include who mixes the IV bags and where supplies are sourced. The U.S. Food and Drug Administration has published guidance on compounding pharmacy oversight, since some clinics use compounded vitamin blends rather than commercially manufactured products. Patients with kidney or heart conditions should mention this before any infusion, since fluid overload is a real risk for certain patients.

A few quick checks before booking:

1. Ask who the supervising or collaborating physician is
2. Confirm staff administering IVs hold current nursing licenses
3. Check whether the clinic screens for medical conditions before treatment

What This Means For Patients And Clinic Owners

IV hydration therapy sits at an interesting point between convenience and clinical care. For patients, understanding that a physician relationship stands behind the clinic offers a simple way to judge legitimacy. For nurse practitioners opening these clinics, securing that oversight early keeps the business compliant from day one.

The service will likely keep growing as more people look for quick wellness options outside a hospital setting. Patients who ask a few direct questions, and clinic owners who line up proper physician oversight before opening, both end up better protected either way.

This is a guest blog entry. 

Tyler Berl on Navigating Career Transitions in Healthcare: Moving From Paramedic Work to Registered Nursing

Healthcare careers can change considerably over time. A clinician may spend years in emergency medicine before moving into trauma care, pediatrics, or critical care transport, then decide to return to school for another degree. Each new role comes with its own learning curve, but it doesn’t erase what came before. The setting may change, along with the responsibilities, but much of the judgment and experience built along the way carries into whatever comes next.

Tyler Berl’s career in Jacksonville, Florida, has taken him through several of those transitions. His background includes emergency department work, trauma care, pediatrics, critical care transport, and, most recently, nursing. His experience also highlights a challenge of changing roles in healthcare: knowing which skills transfer easily, where additional training is needed, and how to make years of experience useful in a new setting.

Image Source: Unsplash

Why Healthcare Careers Change Over Time

Clinicians move between roles and specialties for many reasons. Some pursue additional credentials that open the door to different kinds of work. Others respond to changing staffing needs, discover a new area of interest, or decide the demands of one specialty no longer fit the career they want.

Experience can also change what someone wants from the work. A paramedic who has spent years managing emergencies in the field may become interested in what happens after a patient reaches the hospital. Someone working in adult medicine may want to move into pediatrics. A clinician who has spent years providing direct patient care may eventually decide to return to school and expand their scope of practice.

Those moves inevitably require adjustment, but previous experience still matters. Someone who has worked in pediatric transport, for example, already understands how quickly a patient's condition can change and what it takes to manage equipment in unpredictable circumstances. A clinician with trauma experience has spent years deciding which problems need attention first. Those skills don't disappear simply because the job title changes.

Understanding What Transfers to a New Role

Before moving into a different area of healthcare, it can help to look closely at what the new role requires and compare it with your existing experience. Some skills are specific to a particular setting, while others remain useful almost anywhere patient care happens.

Assessment is one example. The environment may change, but recognizing when a patient is deteriorating remains important whether someone is working in an ambulance, an emergency department, or a hospital unit. The same is true of communicating with patients and families, following clinical protocols, and staying calm enough to make decisions when circumstances change quickly.

Technical experience can transfer as well. A clinician with a background in airway management, ventilator care, or other forms of respiratory support isn't starting from scratch when those skills carry over to a different clinical setting. The equipment, procedures, or scope of practice may change, but the underlying knowledge provides a foundation to build on.

Being specific about that experience is particularly useful during a career transition. Instead of thinking broadly about having spent a certain number of years in healthcare, clinicians can identify the situations they've handled independently, the procedures they know well, and the kinds of decisions they've already had to make. That provides a much clearer picture of what they bring to a new role.

Recognizing What Still Needs to Be Learned

Previous experience doesn't eliminate the need for additional training. Moving into a new clinical role usually means encountering genuinely unfamiliar areas, and identifying them early can make the transition easier.

For a paramedic moving into nursing, that might include a much broader range of medications, longer-term care planning, different documentation requirements, and new scope-of-practice boundaries. 

Someone changing specialties may need to become familiar with a different patient population, new equipment, or conditions they haven't managed regularly before.

Experienced clinicians may actually find some of these transitions uncomfortable because they're accustomed to feeling confident in their work. Being highly capable in one environment doesn't automatically produce the same level of confidence in another.

A more practical approach is to identify what needs strengthening and work through those areas one by one. Structured study, hands-on practice, and simulation can all help. Visual tools can also help when returning to subjects learned years earlier but not used regularly since. Resources for studying anatomy in three dimensions, 3D anatomy resources, can make it easier to revisit anatomical relationships that may have become less familiar after years in a specialized role.

The point isn't to relearn an entire healthcare education from the beginning. It's to determine which parts of the new job aren't already supported by previous experience and give those areas the attention they need.

Making Room for the Unexpected

Career transitions don't always follow a professional timeline. Healthcare workers step away from jobs for many of the same reasons everyone else does. They relocate, care for family members, return to school, or find that the timing of a license or job opportunity doesn't line up neatly with the rest of their lives. 

Tyler Berl experienced this himself after completing his nursing degree. He spent several months away from clinical work while caring for his grandmother in Texas before returning to practice in Florida.

A period away from work doesn't necessarily change the experience someone has already accumulated, but it can create practical issues when returning. Keeping certifications and other credentials current during a planned break can make the process easier, especially in fields that require regular renewals.

It also helps to be straightforward about why you took a break. Family caregiving, education, relocation, and other life circumstances are common reasons for stepping away from clinical work. You don't need to present them as anything more complicated than they are.

Choosing a Role That Builds on Previous Experience

Once someone is ready to return to work or enter a new specialty, the first available position isn't always the best long-term fit. A good next role should offer some familiarity while still providing room to develop.

That might mean choosing a position where an existing strength is immediately useful while you develop another skill with support. A clinician with years of emergency experience, for example, may be new to a particular nursing role but already comfortable assessing unstable patients and working under pressure. That gives them something familiar to rely on while they learn the new parts of the position.

Orientation and preceptorship matter here, too. Moving into a different clinical setting requires asking questions and learning workflows that may be unfamiliar, even for someone with extensive healthcare experience. Having a strong preceptor can make it easier to connect previous knowledge with the expectations of the new role.

The best transition isn't necessarily the one that produces the biggest change in title. Sometimes a position that builds naturally on existing strengths while filling important gaps creates more options later.

How Tyler Berl’s Career Has Developed

Tyler Berl’s own career shows how several different clinical roles can build on one another over time. He became a licensed paramedic in 2011 and spent six years working in the emergency department at Orange Park Medical Center. His experience later expanded to trauma care, pediatrics, and inter-facility critical care transport, including transporting pediatric patients requiring advanced respiratory support during the COVID-19 pandemic.

Alongside his clinical work, Berl earned a bachelor's degree in psychology with a minor in public health. He later returned to school for nursing and completed his degree in 2025. After taking time away to care for his grandmother in Texas, he returned to clinical work in Florida.

On paper, those experiences fall into several different categories. In practice, each one added another perspective to the same broader clinical background. Emergency medicine developed one set of skills, trauma and transport expanded them, and nursing added responsibilities outside his earlier scope of practice.

For clinicians considering a similar change, it can help to view a career the same way. A new credential or specialty doesn't have to replace what came before. It can add another layer to the experience you already have.

About Tyler Berl

Tyler Berl is a registered nurse and licensed paramedic based in Jacksonville, Florida, with board certifications in emergency medicine, pediatrics, and tactical medicine, as well as critical care transport certification. His clinical strengths include advanced cardiac life support, airway management, rapid sequence intubation, ventilator management, and pediatric assessment.

His background includes fifteen years of frontline experience across emergency departments, trauma response, pediatric care, and critical care transport. He also holds a bachelor's degree in psychology with a minor in public health from the University of North Florida and completed his nursing degree at Florida 

State College at Jacksonville in 2025

His career is a useful example of how experience can accumulate across different areas of healthcare. 

Moving into a new role still requires learning, adjustment, and sometimes additional education, but it doesn't require leaving everything behind. The experience built in one setting often becomes part of what makes a clinician more capable in the next.

This is a guest blog entry.

What Goes Into Designing a Clinical Trial Before the First Patient Enrolls?

By the time the first patient enrolls in a clinical trial, an enormous amount of work has already taken place behind the scenes. 

Clinical research cannot simply begin with a promising treatment and a group of willing participants. Researchers need to establish what they are trying to learn, how they will measure it, who should participate and how the resulting data will be analyzed. Ethical considerations, patient safety, operational feasibility and regulatory requirements all have to feed into the design. 

Good trial design is therefore as much about asking the right questions as it is about finding answers.

Defining a Clear Research Question

Every clinical trial starts with a question. However, turning a broad scientific idea into something that can be tested reliably requires considerable refinement.

Researchers may want to determine whether a treatment works, whether one dose performs better than another or how a new intervention compares with an existing standard of care. The objectives must be specific enough to guide everything that follows.

This early work is particularly important because decisions made at the design stage influence the trial protocol, participant population, endpoints and statistical analysis.

Deciding Who the Trial Needs to Study

The next challenge is defining the participant population.

Eligibility criteria determine who can and cannot enter a trial. Depending on the research question, factors such as age, diagnosis, disease severity, previous treatments and other health characteristics may all be relevant.

Make the criteria too broad and researchers could introduce unnecessary variation that makes the treatment effect more difficult to interpret. Make them too restrictive and recruitment may become difficult, while the results might apply to a narrower patient population.

Finding an appropriate balance requires researchers to think about both scientific validity and how the study will operate in practice.

Choosing Meaningful Endpoints

Researchers also need to determine exactly what success will look like.

Endpoints are the outcomes used to evaluate what happens during a clinical trial. These might relate to symptoms, disease progression, survival, laboratory measurements or other clinically meaningful changes.

Primary endpoints are especially important because they are closely connected to the trial's main objective. Secondary endpoints can then provide additional information.

Choosing endpoints therefore involves more than selecting measurements that are convenient to collect. They need to help answer the research question in a scientifically useful way.

Working Out How Many Participants Are Needed

A trial also needs enough participants to provide meaningful evidence.

Sample size calculations draw on statistical assumptions about factors such as the expected treatment effect and variability in outcomes. If a trial is too small, it may struggle to distinguish a genuine treatment effect from chance. Recruiting substantially more participants than necessary, meanwhile, can increase costs, timelines and participant exposure.

Modern trial design solutions can help researchers explore different assumptions before committing to a design. Specialist statistical software and services available through cytel.com can support teams as they assess different clinical trial design scenarios and their statistical characteristics.

This ability to explore possibilities before recruitment begins can be particularly valuable when researchers are dealing with uncertainty.

Making the Trial Work in the Real World

A statistically elegant clinical trial is of limited value if it is almost impossible to conduct.

Design teams therefore need to think about the experience of participating in the study. How often will patients need to visit a research site? How long will appointments take? Are particular tests difficult to access? Could the demands placed on participants make recruitment or retention harder?

These practical questions can influence whether a theoretically strong trial succeeds once it moves into the real world.

Researchers must also consider the capabilities of participating sites, the availability of suitable patients and whether the proposed schedule is realistic. A design that looks effective on paper can create significant problems if it asks too much of patients, investigators or research sites.

Planning the Analysis Before Seeing the Results

One of the most important principles of rigorous research is deciding how evidence will be evaluated before researchers know what that evidence says.

Statistical planning establishes how outcomes will be compared, how missing data may be addressed and how the trial's hypotheses will be tested. For more complex designs, researchers may also use simulations to understand how different trial scenarios could behave.

Doing this work in advance reduces the risk of analytical decisions being influenced by the results themselves. It also creates a clearer framework for interpreting the evidence once data begins to emerge.

The First Patient Is a Milestone, Not the Beginning

“First patient enrolled” may sound like the beginning of a clinical trial, but scientifically, it comes much later.

Before reaching that milestone, researchers may have spent months or even years defining objectives, selecting endpoints, modelling sample sizes, developing statistical approaches and assessing whether the study can realistically be delivered.

Much of that work will never be visible to the people who eventually participate in the study. Yet it plays a major role in determining whether their contribution produces evidence that researchers, clinicians and regulators can meaningfully interpret.

The strongest clinical trials are not simply well run once recruitment begins. They are carefully designed long before the first participant arrives.

This is a guest blog entry.

Jaime Caballero, MD, on the Shift From Evaluation to Optimization in Pre-Surgical Cardiac Assessment

For decades, the phrase most patients heard before an operation was "cardiac clearance," a simple sign-off that the heart could tolerate anesthesia and surgery. Interventional cardiologist Jaime Caballero, MD, has watched that approach change firsthand. Today, the weeks before surgery can do more than identify potential problems. They can give physicians time to address those problems and help patients go into surgery in better shape. 

A patient who has simply received clearance may still have blood pressure that needs attention, an undiagnosed heart condition, or medications that need to be adjusted. Taking the time to address those issues before surgery can give patients a stronger starting point and help physicians anticipate problems before they arise.

 Better imaging, more precise risk assessments, and closer communication between specialties have also changed what happens during those weeks. Instead of treating the pre-operative visit as a simple yes-or-no decision, doctors can use it to get a clearer picture of the patient's cardiovascular health and decide what, if anything, needs attention before surgery. That extra preparation can be especially useful for older patients and those managing multiple health conditions.

Image Source: Unsplash

Why the Old Model Fell Short 

The traditional clearance model asked a straightforward question: Is this patient healthy enough to undergo surgery? That question still matters, but it doesn't tell doctors everything they need to know.

 A patient might appear to be a reasonable surgical candidate while still dealing with poorly controlled blood pressure, an undiagnosed valve problem, or a rhythm disturbance that could become more serious under the stress of anesthesia. A basic evaluation might catch the most obvious concerns while missing other issues that could affect the procedure.

 The idea of "clearance" also made it easy to treat the evaluation as the end of the process. Once the patient received sign-off, everyone could proceed to the operation. But the time between the evaluation and surgery can allow physicians to make changes that improve the patient's starting point.

 That makes earlier attention to cardiovascular health especially useful. Efforts focused on community education on heart disease have helped more people recognize conditions they might otherwise overlook. Bringing that same awareness into the pre-surgical setting gives physicians another opportunity to identify and address problems before they complicate an operation.

 Sharper Tools for Seeing Risk

Better tools have also changed how physicians assess patients before surgery.

Modern risk assessments look at more than a patient's medical history. Depending on the situation, physicians can consider functional capacity, biomarkers, the planned surgery, and other factors to get a clearer picture of what the patient may face.

When those assessments raise questions, additional testing can help answer them without automatically sending someone into an invasive procedure.

Stress echocardiography, cardiac CT, and newer echocardiographic techniques can show how the heart performs under different conditions and reveal problems that might not appear during a routine office visit. A resting electrocardiogram may look normal, for example, while a stress test can reveal an issue that appears only when the heart has to work harder.

The goal isn't to order every available test. Physicians can use the information they gather to determine who needs further treatment and who can safely move ahead with surgery. That approach can spare patients unnecessary delays and expenses when additional intervention won't change their care.

More hospitals can also offer these tools than in the past. Tests once associated mainly with major academic medical centers have become part of routine care in many community hospitals, giving more patients access to a deeper cardiovascular assessment before surgery.

From Evaluation to Actual Preparation

The biggest change in pre-surgical cardiac care comes after doctors identify the risks.

If a patient's blood pressure runs too high, physicians can work to bring it into a safer range before surgery. If the patient has anemia, the care team can address it before the procedure. Physicians can also review medications and decide which ones the patient should pause, continue, or start before surgery. 

In some cases, preparation may involve a procedure of its own. A patient with severe, symptomatic coronary disease, for example, may benefit from revascularization before undergoing a major non-cardiac operation. An interventional cardiologist can help determine whether a stent, additional medical treatment, or another approach makes the most sense for that particular patient.

The training behind those decisions is reflected in recognized medical directories of board-certified interventional specialists. But the goal isn't to intervene simply because an intervention exists. The goal is to determine what, if anything, will actually improve the patient's chances of a safe recovery from surgery. 

Timing also matters. Waiting too long to address a cardiovascular problem can leave a patient carrying unnecessary risk into the operating room. Treating a condition too aggressively, however, can delay an important operation without providing enough benefit to justify the delay.

That balance requires experience with complex cardiovascular disease. A physician's documented record of interventional cardiology practice can provide useful context when a surgical team decides how much preparation a particular patient needs.

 The Team Around the Patient

Pre-surgical optimization also depends on communication. Surgeons, anesthesiologists, primary care physicians, and cardiologists each bring a different perspective to the patient's health. When they share that information early, they can build a more complete plan.

The cardiologist isn't simply there to issue a final verdict. The cardiologist becomes part of a larger conversation about the patient's health, the planned operation, and what needs to happen before the procedure.

Patients should be included in that conversation as well.

It helps to understand why a doctor wants to change a medication, why surgery might need to wait a few weeks, or why a particular symptom needs further attention. When patients understand what their doctors are trying to accomplish, they're better positioned to follow the plan and recognize when something changes.

That kind of communication can make the process feel less like a series of appointments and more like one coordinated plan.

What Optimization Can Mean for Recovery

Preparing a patient before surgery can also affect what happens afterward.

A patient who enters surgery with better-controlled blood pressure, properly managed medications, and known cardiovascular risks may handle the physical stress of the procedure more effectively. That preparation can reduce the likelihood of complications such as arrhythmias or cardiac strain and may make the recovery period easier to manage.

The same preparation can help the patient transition back to regular cardiovascular care. Once the cardiologist has reviewed the patient's health and medications, the care team has a clearer understanding of why certain changes occurred and what to monitor afterward.

Something that happens during surgery can also change the patient's longer-term cardiovascular care. A medication started before the operation may need to continue afterward. A new finding may call for additional follow-up. Instead of treating the pre-surgical evaluation as a one-time appointment, physicians can use what they learn throughout the process to guide the patient's post-surgical care.

 Looking Ahead

 Technology will give physicians even more information to work with before surgery. Wearable devices can already track heart rate, rhythm, and activity between office visits, giving doctors a more continuous view of how a patient is doing.

 Machine learning may add another layer by helping doctors identify patterns across large amounts of surgical and cardiovascular data. As minimally invasive cardiac procedures continue to develop, physicians may also gain more options for addressing cardiovascular problems before a patient undergoes another type of surgery. 

The basic idea behind optimization is simple. The weeks before surgery aren't just a time to decide whether a patient's heart can handle the procedure. They're also an opportunity to identify problems, address manageable risks, review medications, and provide the patient with a better starting point. 

Physicians such as Jaime Caballero, MD, approach pre-surgical cardiac care with that broader view rather than treating clearance as the final step.

For patients, the difference may come down to having a few more questions answered and a few more problems addressed before they reach the operating room. Those steps can help patients enter surgery as prepared as possible and give their care team a clearer understanding of what they need before, during, and after the procedure.

This is a guest blog entry.