5 Things Patients With Low Back Pain Need From Their Doctors

 Hopelessness. Fear. Isolation. These are the feelings reflected in the stories we heard from people living with low back pain (LBP) who participated in two focus groups held by the Duke Clinical Research Institute

opens in a new tab or window. These patients, members of our 300-person "Spine Squad," volunteered to share their lived experiences with us.

Threading through the conversation was frustration with their doctors. These patients are not alone in their pain, and their experiences with physicians are not outliers.

LBP is the leading causeopens in a new tab or window of years lived with disability worldwide and one of the most expensiveopens in a new tab or window conditions to treat. It is one of the top reasonsopens in a new tab or window why patients seek healthcare from both primary care physicians (PCPs), physiatrists, and spine surgeons. Most PCPs have little in their toolboxopens in a new tab or window to directly address the needs of patients with LBP, but specialty care is also not the answeropens in a new tab or window for many patients. Evidence supportsopens in a new tab or window the use of nonpharmacological (non-drug) care, including spinal manipulation, acupuncture, and exercise as first-line care. However, these treatments do not fall under the purview of PCPs or specialists, resulting in a significant disconnect between clinical practice guidelines and real-world patient care.

Neither providers nor patients are satisfied with the status quo. Doctors are frustrated because they have limited time to spend with patients, LBP is difficult to definitively diagnose, and effective medical treatments are elusive. Patients are frustrated because the treatments they try often do not work wellopens in a new tab or window and they feel unheard or misunderstood by the medical community.

Value-based care modelsopens in a new tab or window emphasizing patient-centered approaches offer hope for change. In the meantime, we can improve how we approach LBP care now by focusing on these five things patients told us they need from their doctors.

To Feel Heard

"He acted like the pain was all in my head" and "All she wanted to talk about was my diabetes."

Patients with low back pain want their concerns taken seriously, to feel that you, their provider, are listening, and that you respect their lived experience. They often feel ignored or dismissed by healthcare professionals. It is important to figure out what matters mostopens in a new tab or window to the patient. Listen to their concerns and acknowledge their experiences and frustrations before talking about their other health issues, even if this means making another appointment. An empathetic, patient-centered approach will build trust.

To Understand the Cause of Their Pain

"They told me, 'It's just chronic pain.' That isn't a diagnosis. Something's causing it, and I want to know what it is."

Patients are searching for answers. Inherent in the biomedical model is the expectation of a diagnosis and a cure. This is one reason why PCPs order imaging -- patients want proof that their pain is real and hope imaging will lead to a solution. Unfortunately, early MRIs and x-raysopens in a new tab or window are rarely helpful. Ancillary findings or common conditions of aging can exacerbate fear-avoidance behavior. They can also increase the likelihood of unnecessary procedures and the transition from acute to chronic LBP. An alternative to consider is recommending several weeks of guideline-concordant non-drug care first.

Reassurance and Support

"The uncertainty of living with pain forever is worse than the pain itself."

Chronic LBP often leads to social isolation, exacerbating other mental and emotional challenges. Patients crave reassurance that they're not dealing with a life-threatening disease, that their pain won't be permanent, and that they can maintain a fulfilling life despite their chronic pain. It is important to remember not only the actual words said, but also how they are said. Patients want clear information delivered in plain language with an empathetic tone. There is a difference between reassurance and casual dismissal of their lived experiences.

Access to Effective Treatment Options

"I just don't know what to do next."

The frustration patients feel with a casual dismissal is compounded by the often unclear treatment options presented. They want to know what treatments are most likely to help and how to access them. Good sources of information include the Lancet series on LBPopens in a new tab or window and the American College of Physicians LBP guidelineopens in a new tab or window. Providing education on first-line, non-drug treatments, along with appropriate referrals, can empower patients to take an active role in their health. This may lead to more positive outcomes as patients feel more involved in their healing process.

Care Coordination

"Doctors don't talk to each other, so I have to piece together my own treatment plan."

Patients can find themselves caught in a loop between their PCP and specialists. It is well known that lack of coordination in healthcare delivery can create confusionopens in a new tab or window and delay effective treatment. It can also increase patient burden when patients are forced to develop their own treatment plans, navigating multiple prescriptions and sometimes conflicting physician advice without a clear sense of how everything fits together. This situation is particularly challenging for individuals with multiple chronic conditions. One solution is the use of multidisciplinary integrated pain management teams. Such teams are becoming more common and offer models for improving patient outcomes and fostering a more patient-centered approach.

We have much to gain by listening to the needs expressed by LBP patients. They remind us to pay greater attention to the power of the spoken word, offer reassurance whenever appropriate, and provide guidance on effective treatment options. We can also learn from new models of care, including multidisciplinary approaches and value-based options. While considerable work lies before us to optimize management and treatment for LBP, these initial steps can help transform the experience of those living with LBP, offering them relief from their physical symptoms and the respect they deserve.

Christine Goertz, DC, PhD,opens in a new tab or window is a professor in musculoskeletal research at the Duke Clinical Research Institute, vice chair for Implementation of Spine Health Innovations in the Department of Orthopaedic Surgery at Duke University, and core faculty at the Duke Margolis Institute for Health Policy in Durham, North Carolina.

https://www.medpagetoday.com/opinion/second-opinions/114573

Brain Edema, Imaging Abnormalities Reported for Alzheimer's Drug

 

• Donanemab raised the risk of amyloid-related imaging abnormalities (ARIA) in Alzheimer's patients.
• Many ARIA events were mild to moderate, asymptomatic, and occurred early in treatment.
• ARIA can be serious or fatal, requiring careful patient selection and monitoring.

Treatment with donanemab (Kisunla) raised the risk of amyloid-related imaging abnormalities (ARIA) in people with early symptomatic Alzheimer's disease, a secondary analysis of trial data showed.

In phase II and III trials of nearly 2,000 participants, the frequency of ARIA was 37% in the donanemab group compared with 14.2% in the placebo group, reported John Sims, MD, of Eli Lilly and Company in Indianapolis, and co-authors. In an open-label extension of about 1,000 patients treated with donanemab, the frequency of ARIA was 32%.

ARIA with edema or effusions (ARIA-E) occurred in 24.4% of donanemab-treated patients in the placebo-controlled trials and 19.8% of donanemab-treated patients in the open-label extension. ARIA with microhemorrhages or hemosiderin deposits (ARIA-H) occurred in 31.3% and 27.2%, respectively, the researchers noted in JAMA Neurologyopens in a new tab or window.

ARIA was associated with APOE4 status and baseline imaging findings. Most ARIA events were mild or moderate, asymptomatic, and initially presented within the first six donanemab infusions. In 58.3% of donanemab-treated participants with ARIA-E, the first event occurred by the third infusion; symptoms most frequently reported were headache and confusion.

In the placebo-controlled studies, there were 17 deaths in the donanemab groups and 12 deaths among people who received placebo. In the phase III trial, three donanemab-treated participants had serious ARIA and subsequently diedopens in a new tab or window. Besides the ARIA-related deaths, there was no pattern or trend in the events leading to deaths in the placebo-controlled trials and the open-label addendum.

Beyond these studies, one patient, an APOE4 heterozygote, died due to ARIA-E after the fifth donanemab dose in the long-term extension of the phase III trial, Sims and co-authors said. One death also occurred following thrombolytic administration for potential acute stroke-like symptoms in a donanemab-treated patient; an MRI the same day showed severe ARIA-E and the patient subsequently died due to intracranial hemorrhage.

"While ARIA-E events were typically transient and asymptomatic, ARIA can be serious, life threatening, or fatal; therefore, safety monitoring is necessary with donanemab as with other amyloid-targeting therapies used in slowing disease progression in early symptomatic Alzheimer's disease," Sims and colleagues wrote.

Donanemab is an amyloid-directed antibody approved in 2024opens in a new tab or window to treat Alzheimer's disease. Its label carries a boxed warningopens in a new tab or window for ARIA-E and ARIA-H, stating that ARIA is often asymptomatic, that ARIA-E can mimic ischemic stroke, and that serious intracerebral hemorrhages can occur. The warning also indicates that APOE4 homozygotes treated with this class of medication have a higher incidence of ARIA.

To help clinicians understand and communicate risks to patients, the American Academy of Neurologyopens in a new tab or window (AAN) Quality Committee published practical guidance in 2023 about patient selection and treatment monitoring with anti-amyloid monoclonal antibody therapies, which also include lecanemab (Leqembi).

The donanemab secondary analysis "largely reinforces some of the key observations in the donanemab clinical trials -- that careful patient selection and close monitoring are paramount to the safe administration of the drug," noted AAN committee member Lyell Jones, MD, of the Mayo Clinic in Rochester, Minnesota. "It also underscores prior observations that complications tend to emerge early in the course of donanemab administration," Jones told MedPage Today.

"While these complications and the primary outcome in this analysis are called 'amyloid-related imaging abnormalities,' it's important to recall that these are not always isolated imaging findings, and a meaningful proportion of patients have symptomatic complications with this class of drugs," Jones added. "It should also be noted that most of the investigators in this study are affiliated with or employed by the drug manufacturer."

The analysis used data from the placebo-controlled portions of the phase II TRAILBLAZER-ALZopens in a new tab or window and phase III TRAILBLAZER- ALZ 2opens in a new tab or window randomized trials, which were conducted from December 2017 to December 2020 and from June 2020 to April 2023, respectively. Additional data from a stand-alone open-label addendum conducted from August 2021 through August 2023 were also included. The ongoing TRAILBLAZER-ALZ 2 long-term extension study was not part of the analysis.

The study included 257 people from TRAILBLAZER-ALZ, 1,736 people from TRAILBLAZER-ALZ 2, and 1,053 people from the open-label addendum. All had early symptomatic Alzheimer's disease and elevated amyloid levels. The placebo-controlled trials had tau inclusion criteria, but the addendum study did not.

Mean age was 74, and 55.6% were women. Participants received donanemab or placebo intravenously every 4 weeks for up to 72 weeks. Outcomes were assessed through 76 weeks.

ARIA-E was associated with six baseline variables. Risk was increased with a higher number of APOE4 alleles, a greater number of microhemorrhages, the presence of cortical superficial siderosis, greater amyloid plaque, and elevated mean arterial pressure. Risk was decreased with use of antihypertensives.

Longer-term information about people who experienced ARIA during the trials are needed, Sims and co-authors acknowledged.

Modified dose titration may reduce ARIA occurrence, they noted. Early data from the phase IIIb TRAILBLAZER-6opens in a new tab or window study showed an alternate dosing plan lowered the risk of ARIA-E.

Disclosures

This study was sponsored by Eli Lilly and Company.

Sims and 15 co-authors were employees of and shareholders in Eli Lilly during the conduct of the study.

Other co-authors reported relationships with Eli Lilly and other pharmaceutical companies.

Jones reported no relevant disclosures.

Primary Source

JAMA Neurology

Source Reference: opens in a new tab or windowZimmer JA, et al "Amyloid-related imaging abnormalities with donanemab in early symptomatic Alzheimer disease: secondary analysis of the TRAILBLAZER-ALZ and ALZ 2 randomized clinical trials" JAMA Neurol 2025; DOI: 10.1001/jamaneurol.2025.0065.

https://www.medpagetoday.com/neurology/alzheimersdisease/114601

Hospital-at-Home Extension Included in Proposed House Funding Bill

 As Republican House leaders finalize their stopgap funding bill, one item tucked inside is the extension of the CMS "Hospital-at-Home" (H@H) waiver program.

The program, which currently expires on March 31, allows hospitals to provide hospital-level care to certain patients in their homes, even though doing so would normally violate a condition of participation in Medicare and Medicaid requiring 24/7 availability of nursing care. Hospitals participating in the program get paid the same amount for H@H patients as they would if the patient were actually in an inpatient hospital bed. The provision in the House budget bill would extend the program through 2029.

The program, which is also called the Acute Hospital Care at Home program, started in November 2020 during the height of the COVID-19 pandemic. Congress has extended the H@H waivers twice, first in 2022 for 2 years and then again at the end of 2024 for 90 days, according to a fact sheetopens in a new tab or window from the American Hospital Association (AHA). Both extensions received no score from the Congressional Budget Office, meaning they were considered budget-neutral. As of November 2024, 378 hospitals, across 140 systems and 39 states, have been approved to provide H@H services to patients, according to the AHA.

Hospital Officials Like the Program

The program has worked well for Mass General Brigham in Boston, which has been using it since 2017, according to Stephen Dorner, MD, MPH, chief clinical officer of the hospital's H@H program. "We've had 5,800 [H@H] patients come through since 2022, which is 25,000 bed days," he said in a phone interview, noting that it's used only for patients with certain conditions -- such as pneumonia or heart failure -- that can be managed at home with remote monitoring and visits by health professionals.

"We're in the homes a minimum of two times a day but often more than that," Dorner explained. "There's a federal requirement that you have to be able to reach patients within 30 minutes." Because the program operates in five different hospitals -- with three ambulance depots -- "that enables us to support patients in 72 towns around greater Boston, which is about 80% of the patients served by our hospitals."

Published research shows that patients who receive hospital care at home "[do better] when compared with brick-and-mortar hospitals," he said. "There are lower rates of complications, lower rates of mortality, and lower rates of readmission. Patients are up and ambulatory more than when they're in the brick-and-mortar hospital because they're actually moving around their own home instead of being confined to a hospital room ... [It also brings] needed capacity relief to the brick-and-mortar hospitals with the capacity crisis that hospitals face."

But doesn't the H@H program take hospital staff away from providing on-site care? Not really, Dorner said. "One of the key provisions of the federal waiver is that paramedics who have additional training as mobile integrated health paramedics or community paramedics can deliver care to patients alongside nurses. So that's great, because every patient still gets a nurse, and a nurse is still advancing their care plan, but for more technical visits, where it's a blood draw or ... an infusion of a medication, that can be performed by a paramedic. Then that permits a nurse to be able to support a more patient education-heavy visit, for example, or a more complex visit for wound care."

Not a New Idea

Dorner added that "by and large, these programs are functioning very much like startups, trying to figure out and test what this care model really needs to look like at scale. Most home hospitals are operating a handful of beds -- maybe a dozen or two beds at a time -- whereas, [we have] a much larger operation, and so the imperative of us getting an extension for this is less about the financials, and it's more about just having the regulatory framework to permit us to continue testing this care model and honing it."

But Harold Miller, president and CEO of the Center for Healthcare Quality and Payment Reform in Pittsburgh, said that although hospital-at-home is a good idea, the waiver program isn't the best way to implement it. "There should be a [permanent] hospital-at-home payment program," he said in a phone interview. "The problem is, there isn't anything specifically designed for that."

And that's not for lack of trying. Back in 2017-2018, CMS's Physician-focused Payment Model Technical Advisory Committee (PTAC) -- which was formed to consider various value-based payment models for possible adoption -- recommended two hospital-at-home modelsopens in a new tab or window, "but CMS refused to implement them," Miller said. "Then all of a sudden," after the pandemic hit, "CMS created this waiver that said you can do hospital-at-home during the pandemic. That enabled hospitals to do what they'd proposed to do, but it wasn't designed to [permanently] support it."

Problematic Payment Structure

One problem with the waiver program, Miller said, is that there is no effort to determine whether hospitals are being paid accurately under the program. "In some cases, [H@H] may be more expensive" than what the hospital is reimbursed, "and in some cases less."

Another issue is that the group of patients who can really benefit from H@H is actually rather small, said Miller. "If you think about it, there are not that many patients who can be taken care of adequately at home without a nurse right down the hall. But there are subsets of patients who can be taken care of at home without being in the hospital because they don't necessarily need the continuous kind of monitoring they need in the hospital, but they need something more than they could ordinarily get at home."

Although the waiver program enables that kind of service, the concern is that because the waiver allows the hospital to be paid inpatient rates even for patients who need less than inpatient-level care, "the hospital could have a perverse incentive to send more patients home than should be at home," he said, noting that the advantage of the models recommended by PTAC was that they set forth criteria for when to consider H@H for a patient, and they varied the payment levels depending on what level of care was needed.

All that being said, the waiver program should be extended because without it there would be no program at all, Miller added. "But you can't just keep extending the waiver ... They should extend the waiver for a period of time -- a year or 2 -- but during that time there should be a requirement for CMS to create a hospital-at-home program that is designed to pay appropriately for hospital-at-home care for patients who need it."

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/114602

Med test performed 93M times a year in US may cause cancer due to ‘unfathomable’ mistake

 As the federal government investigates America’s chronic disease epidemic, some experts are warning that a popular diagnostic tool may be a contributing factor.

CT scans, a go-to for diagnosing everything from tumors to infections to bone fractures, are facing increased scrutiny. Experts say the radiation doses they deliver can vary dramatically — and often exceed what’s necessary.

“Many patients still routinely receive radiation doses two or three times what they should,” said Dr. Rebecca Smith-Bindman, a professor at the University of California-San Francisco medical school. “That will lead to cancer in a small percentage of patients, approximately 36,000 cancers every year.” 

A CT scan can show detailed images of any part of the body, including the bones, muscles, organs and blood vessels.Peakstock – stock.adobe.com

What are CT scans? 

Computerized tomography is a medical imaging procedure that uses X-rays to create detailed, three-dimensional images of the body.

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Every year, an estimated 93 million CT scans are performed in the US, up from just 3 million in 1980. ​​The surge isn’t accidental — these machines have revolutionized diagnostics, reducing the need for invasive procedures like exploratory surgeries, per Harvard Health. 

Despite their rise in use, experts warn that radiation doses from CT scans vary widely among clinics, with little oversight. One machine can expose a patient to 10 or 15 times as much radiation as another, according to NBC News.

“It’s unfathomable,” Smith-Bindman told NBC. “We keep doing more and more CTs, and the doses keep going up.”

Researchers have also noted that US doctors order far more imaging than physicians in other parts of the world, arguing that some of it is unnecessary and potentially dangerous.

What are the risks of CT scans? 

CT scans use ionizing radiation, which can damage DNA. While most of the damage is repaired by cells, some errors can cause DNA mutations, potentially leading to cancer down the road.

The lifetime cancer risk from CT scans is generally considered low, but research suggests the risk increases for patients who undergo multiple scans throughout their lives.

While CT scans are a valuable diagnostic tool, there is a small risk of developing cancer due to radiation exposure.Gorodenkoff – stock.adobe.com
One study found that the lifetime cancer risk from CT scans in a group of over 31,000 patients over 22 years was just 0.7% higher than the general population’s 45%. But for those who underwent multiple scans, the risk shot up, ranging from 2.7% to 12%.

Children are particularly vulnerable to the effects of ionizing radiation. A large international study found that people who had at least one CT scan before the age of 22 are at a significantly increased risk for developing blood cancers, specifically including lymphoid and myeloid cancers, as well as acute leukemia. 

Repeated CT scans of the head during childhood have also been linked to a slight increase in the risk of developing a brain tumor later in life due to radiation exposure.

In a landmark 2009 study, researchers estimated that CT scans were responsible for about 2% of all US cancer cases diagnosed annually. However, NBC notes that the true number is likely greater as the number of scans have increased, though radiologists say dosages of radiation have declined per scan.

New radiation regulations underway

New Medicare regulations are aiming to make CT scans safer — without scaring patients away from potentially life-saving imaging tests.

In January, the Centers for Medicare and Medicaid Services (CMS) implemented new rules requiring providers to report more detailed information on radiation levels emitted by their machines. The guidelines, finalized in the last stretch of the Biden administration, also mandate stricter assessments of CT scan doses, quality and necessity.

The requirements will be phased in over the next three years for hospitals, outpatient centers and doctors nationwide. By 2027, non-compliant providers could face financial penalties.

When the Biden administration announced the changes, a CMS spokesperson told NBC News that excessive radiation exposure is a health risk that can be tackled through better measurement and feedback to healthcare providers.

“No one intentionally harms their patients; they just haven’t been paying attention to radiation dose,” said Smith-Bindman, who worked with CMS to develop research solutions aimed at better measuring and assessing the effects of CT scans.

“The measure defines a clear standard for every type of scan with respect to dose and quality, and CMS provides incentives to reach those goals,” she added. “Clinicians can exceed those targets if they deem it necessary; the measure just provides them a way to gauge their performance.”

https://nypost.com/2025/03/11/health/common-medical-test-may-cause-cancer-due-to-unfathomable-mistake/

Zevra Therapeutics Q4 Net Loss Widens, Revenue Decreases; Shares Fall After Hours

 Zevra Therapeutics (ZVRA) reported FY 2024 financial results with net revenue of $23.6 million, including $12.0 million in Q4 2024. The company posted a net loss of $105.5 million ($2.28 per share) for 2024, compared to $46.0 million loss in 2023.

Key highlights include the successful commercial launch of MIPLYFFA following FDA approval in September 2024, with 109 prescription enrollment forms received by year-end. The company entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million.

Cash position stood at $75.5 million as of December 31, 2024. With current operating forecast and excluding PRV sale proceeds, Zevra projects cash runway into 2029. The Phase 3 DiSCOVER trial for celiprolol enrolled 27 total patients, and the company plans to file for EU marketing authorization for MIPLYFFA in H2 2025.

https://www.stocktitan.net/news/ZVRA/zevra-reports-full-year-2024-and-fourth-quarter-financial-tatfchvx49v2.html