Latest news with #clinicalguidelines
Medscape
31-07-2025
- Health
- Medscape
First Guideline on AD Blood-Based Biomarker Tests Released
TORONTO — An expert panel convened by the Alzheimer's Association has released the first clinical guidelines to help clinicians choose the most appropriate blood-based biomarker (BBM) test to aid in the diagnosis of Alzheimer's disease (AD). The evidence-based guideline recommends that tests with ≥ 90% sensitivity and specificity can serve as a substitute for amyloid PET or cerebrospinal fluid (CSF) biomarker testing. Tests with ≥ 90% sensitivity but only ≥ 75% specificity should be used as a triaging test. In this case, a negative result rules out AD pathology with high probability and a positive result should be confirmed with CSF or PET testing. Evidence-based guidelines are key to standardizing the use of BBMs in clinical practice, Rebecca M. Edelmayer, PhD, vice president of scientific engagement for the Alzheimer's Association, told Medscape Medical News. 'The whole purpose of developing the clinical practice guideline is to try to create pragmatic recommendations for clinicians on how to choose the right test for the right patient at the right time,' Edelmayer said. This new guideline is the first step in a developing process, she added. 'The blood-based biomarker area is still a burgeoning field.' The findings were presented on July 29 at the Alzheimer's Association International Conference (AAIC) 2025 and published online simultaneously in Alzheimer's & Dementia . Meeting a Need With the approval of anti-amyloid beta (Aβ) therapies to treat early symptomatic disease, more rapid and accurate diagnosis of AD is becoming increasingly important. A number of different BBM tests are available to clinicians, but the lack of clinical practice guidelines has hindered more widespread use of the diagnostic tools, guidelines authors wrote. A panel of clinical experts, researchers with experience and technical knowledge surrounding BBM, and guideline methodologists conducted a systematic review of the literature to assess the accuracy of BBMs in detecting amyloid pathology for triaging (≥ 90% sensitivity, ≥ 75% specificity) and confirmatory (≥ 90% sensitivity and specificity) diagnostic workup. After a review of 1050 papers, 49 observational studies of 31 different BBM tests were selected for inclusion. The BBMs of interest included plasma phosphorylated-tau (p-tau) and A β tests measuring these analytes: p-tau217, the ratio of p-tau217 to non-p-tau217 ×100 (%p-tau17), p-tau181, p-tau231, and the ratio of Aβ42 to Aβ40. The reference standard tests included CSF, amyloid PET, or neuropathology examination. The relatively low-cost BBM tests are minimally invasive compared with PET and CSF tests and can significantly reduce the physical discomfort and anxiety often associated with lumbar puncture or PET imaging procedures, the authors wrote. The systematic review focused on single analytes, not combinations of different analytes, sometimes referred to a 'blood panel,' noted Edelmayer. Using predefined decision thresholds, the panel determined whether tests have sufficient diagnostic accuracy to be used as a triaging test where a positive test is to be confirmed by PET or CSF, sufficient diagnostic accuracy as a confirmatory test to replace PET or CSF, or insufficient diagnostic accuracy to recommend current use in clinical practice. The recommendations are focused on individuals with either mild cognitive impairment or dementia who are undergoing diagnostic assessment by providers trained and experienced in memory disorders, where AD is the suspected underlying etiology. The guideline does not endorse specific tests or rank them. 'We just don't have enough data at this time,' said Edelmayer. 'We're not ready to pick one single test out of a lineup of tests to say this test is performing much better in a comparative analysis and through systematic review evidence than another test.' Accurate Predictors Researchers now have a clearer picture of how AD pathology evolved over time, with changes in some tau biomarkers occurring very early on, said Edelmayer. 'What we've learned from all of the evidence so far is that some of these biomarkers, like tau 217, tend to be very accurate predictors of Alzheimer's disease biology in the brain, and they can be used to aid in the diagnostic process early on, sometimes even before tau tangle formations can be visualized with brain imaging.' The guideline authors noted some limitations of the evidence. For example, undesirable effects of BBM testing could include false positive or false negative results, which could delay accurate diagnosis and treatment. The authors also cautioned that there's significant variability in the accuracy of diagnostic tests and many commercially available BBM tests do not meet accuracy thresholds. Edelmayer stressed this is the first iteration of the clinical practice guideline and the expert panel is already working on next steps, including determining if these biomarkers can be used as confirmatory or triage tests in cognitively unimpaired people and in a primary care setting. The tests aren't a substitute for comprehensive clinical evaluation by a healthcare professional, said David Knopman, MD, a clinical neurologist and researcher at the Mayo Clinic in Rochester, Minnesota, who commented on the new guidelines for Medscape Medical News . 'The use of any AD-specific biomarker is dependent on the context,' he said. 'For example, the history or no history of cognitive impairment, the objective cognitive assessment, and the presence or absence of features of non-AD biologics.' While he noted the guideline was reasonable for the separate functions of triaging and confirming AD biology, as with any such document, no matter how thoughtfully constructed, there's the risk that people ignore stipulations in the recommendation. 'So people without cognitive impairment will be captured. There's also the risk that the memory disorder clinic is not well versed in non-Alzheimer causes of memory impairment,' he said.
Medscape
02-07-2025
- Health
- Medscape
Decline of Nonrecommended HIV Care in Medicare
TOPLINE: Among Medicare beneficiaries with HIV, the proportion receiving at least one nonrecommended antiviral prescription decreased substantially from 5.1% in 2013 to 0.1% in 2021. METHODOLOGY: Clinical guidelines in 2017 recommended discontinuing older, more toxic antivirals in people with HIV. However, some people continue to take them due to several barriers to switching. This cross-sectional study used a 20% random sample of traditional Medicare beneficiaries with Part-D coverage from 2013 to 2021 and categorized prescribed antivirals as nonrecommended — based on drug toxicity and the availability of more effective alternatives — the remaining being classified as preferred. The analysis examined the proportion of beneficiaries with HIV who received at least one nonrecommended antiviral vs those who received only preferred antivirals. TAKEAWAY: Of the total Medicare beneficiaries with HIV, 1052 (74.1% aged < 65 years; 74.9% men) received at least one nonrecommended antiviral prescription, and 28,019 (75.9% aged < 65 years; 74.4% men) received only preferred antivirals. Compared with beneficiaries who received only preferred antivirals, those who received nonrecommended antivirals were more likely to be from the South (45.6% vs 50.5%; standardized mean difference, 0.10). Didanosine and nelfinavir emerged as the most frequently prescribed nonrecommended antivirals, accounting for 27.5% and 25.3% of prescriptions, respectively. The proportion of beneficiaries receiving nonrecommended antivirals substantially declined from 5.1% in 2013 to 0.1% in 2021. IN PRACTICE: 'Further research should assess how many beneficiaries switched to less toxic antivirals over time (rather than being censored), characteristics associated with switching to safer alternatives, alternative antivirals prescribed instead, and how more recent ART [antiretroviral therapy] guideline recommendations may influence future prescription patterns,' the authors wrote. SOURCE: This study was led by Jose F. Figueroa, MD, Harvard T.H. Chan School of Public Health, Boston. It was published online on May 1, 2025, in JAMA Network Open. LIMITATIONS: The study focused exclusively on traditional Medicare beneficiaries living with HIV, possibly limiting the generalizability of the findings to individuals with HIV covered by commercial insurance, Medicaid, or Medicare Advantage plans. HIV diagnoses relied on claims data. DISCLOSURES: This study was supported by grants from the National Institute on Aging, the Harvard Center for AIDS Research, and the Advancing Clinical Therapeutics Globally program. Some authors reported having financial ties with multiple foundations and pharmaceutical organizations. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
The Independent
01-07-2025
- Health
- The Independent
Using certain type of HRT before menopause could raise cancer risk
An international study examined the link between hormone replacement therapy (HRT) and young-onset breast cancer in women aged 16 to 54. The research found that overall HRT use was not broadly connected to an increased risk of young-onset breast cancer. However, oestrogen -only hormone therapy appeared to decrease breast cancer risk by 14 per cent in younger women. Conversely, oestrogen plus progestin therapy was associated with a 10 per cent increased risk of young-onset breast cancer. These findings offer new guidance for clinical recommendations on HRT use in younger women, where previous information was limited.
Medscape
23-05-2025
- Health
- Medscape
New ASCO AI Tool Promises Fast, Accurate Guidelines Access
The American Society of Clinical Oncology (ASCO) and Google Cloud have recently launched an artificial intelligence (AI)–powered search tool to provide accurate and fast access to ASCO's full library of evidence-based clinical guidelines, the society announced this week. Developed with Google Cloud's Vertex AI platform and Gemini models, the ASCO Guideline Assistant will offer clinicians 'a more dynamic user experience, allowing them to ask follow-up questions for intuitive, easy integration of expert information into their patient care plans,' based on ASCO's published clinical practice guidelines, according to a society press release. 'This partnership unlocks the value of ASCO's trusted guidelines knowledge,' ASCO's chief executive officer, Clifford Hudis, MD, said in a statement. 'Google Cloud's AI expertise is the engine that will drive faster access to critical information, empowering oncology professionals to make rapid, evidence-based decisions for their patients.' At ASCO's annual meeting next week, attendees will have a chance to explore the tool and learn more about 'Oncology and AI.' Notably, the ASCO Guideline Assistant is designed to circumvent 'accuracy concerns often associated with publicly available AI tools,' according to ASCO. While AI tools can help doctors make more informed decisions, save time, and optimize care, experts have also highlighted challenges and concerns with their use. 'Data-related concerns and human biases that seep into algorithms during development and post-deployment phases affect performance in real-world settings, limiting the utility and safety of AI technology in oncology clinics,' Medscape contributor Ravi B. Parikh, MD, and Likhitha Kolla wrote in a 2024 article in Cancer . By providing access to timely, relevant information, the new tool can help alleviate the challenges oncologists face from rising cancer rates in younger Americans, a growing number of cancer survivors, rapidly expanding treatment options, greater fiscal constraints and a projected shortage of oncologists, ASCO noted. 'This is huge!' Sneha Singh, MD, posted on X in response to the announcement. 'Thank you @ASCO and @googlecloud for this guidelines agent!' Another X user, Chiara Corti, MD, encouraged others to 'Try and play with it!' 'All the feedback will be welcomed by @ASCO and @googlecloud,' Corti added.
ABC News
12-05-2025
- Health
- ABC News
New Australian guidelines for miscarriage and early pregnancy loss released
Australia's first comprehensive national guidelines for the treatment of early pregnancy loss have been welcomed by women's health experts. The clinical guidelines, developed by the Royal Australian and New Zealand College of Obstetrics and Gynaecology (RANZCOG), are designed to provide a benchmark for best practice medical care. "We don't actually have a standard of care for miscarriage in Australia because every health service does something slightly different and every clinician probably does something slightly different," Nisha Khot, obstetrician and president-elect of RANZCOG, said. Early pregnancy loss is common in Australia; it's estimated up to one in four pregnancies end in miscarriage, and more than 100,000 couples are affected by miscarriage every year. The clinical guidelines, published in late April, provide recommendations for the treatment of miscarriage, recurrent miscarriage and ectopic pregnancy up to 14 weeks gestation. Ectopic pregnancy occurs when a fertilised egg implants and grows outside the uterus. Dr Khot said in addition to providing health professionals with up-to-date evidence on the medical and surgical management of pregnancy loss, the guidelines were about ensuring empathy was "central to all the care we provide". Among the recommendations is a new definition of recurrent miscarriage, which was previously defined as a woman having three consecutive miscarriages. "[The new guidelines] have very specifically said that it is two miscarriages and they don't need to be consecutive for women to be able to access further testing to find out the cause," Dr Khot said. Isy Oderberg, co-founder of the Early Pregnancy Loss Coalition, said the guidelines would go a long way to supporting women and families who experience early pregnancy loss. "The time to just tell patients to go home and try again is over," Ms Oderberg said. "We need to offer patients proper care, proper oversight, let them know they're not alone, and not compound any grief they are already feeling with substandard care or a lack of empathy." Ms Oderberg, who had seven miscarriages on her way to having two living children, said miscarriage care varied significantly across the country and often came down to luck. "There are times when you go and seek care and you have an incredible, empathetic, knowledgeable clinician who can give you the right guidance and treat you well, both from a medical point of view but also in terms of empathy," she said. "But there are many, many horror stories. "It varies wildly and it gets worse when the person is from a marginalised or minority group, or if they're in a regional or rural area." Culturally, there has long been a discomfort around early pregnancy loss, she said, which has contributed to poor understanding of patients' needs and how to best support them. "We've seen a lot of doctors be dismissive … because it's just seen as a natural part of the reproductive cycle, which to some extent it is, but that doesn't lessen the grief." A global review of evidence in 2021 found the impact and consequences of miscarriage were "underestimated". It called for a comprehensive overhaul of the medical care and advice offered to women who have miscarriages. The new Australian guidelines recommend that communication with patients is "clear, empathetic and respectful" and that health professionals take care with terminology and use of certain phrases when discussing early pregnancy loss. "If the patient refers to their loss as a baby, [doctors] have to take that lead and refer to it in the same way," Ms Oderberg said. "It compounds a patient's grief if they don't take that lead, and use words like 'spontaneous abortion', which is still commonly used by a lot of doctors." In 2024, the federal government committed $9.5 million to miscarriage support and research, including funding a scoping study for a national miscarriage data collection. Ms Oderberg said it was important to understand where early pregnancy loss occurred, who was most affected, and whether rates were increasing. "The reason we need miscarriage data is because you can't create any sort of health policy without knowing who you're creating it for, where they are, how many people need the service … it's a fundamental plank of any decent policy." The Early Pregnancy Loss Coalition is now hoping to develop a national miscarriage road map, similar to the National Stillbirth Action and Implementation Plan, in order to look long-term at patient pathways, quality of care, and research funding. "A lot of what happens in this space of early pregnancy loss is not well understood because it is not well researched," Dr Khot said. "That is because there hasn't been funding for research in this area." In addition to further research, she said more psychological support was needed for women and families experiencing early pregnancy loss. "Whether that be counselling or mental health support, these are things women should have access to without additional costs." Listen to the full story on Radio National and subscribe to the Health Report podcast for more.
