New proteomics-based test could aid in early detection of ovarian cancer

Fewer than half of ovarian cancer patients survive until five years after diagnosis. According to the American Cancer Society, this is because only about one-fifth of ovarian cancer cases are detected early, when the chances of successful treatment and recovery are highest.

“If we could change this reality by detecting (ovarian cancer) at a curable stage, we could save many lives,” said Keren Levanon, a physician-researcher at Chaim Sheba Medical Center in Israel.

In the journal Molecular & Cellular Proteomics, researchers led by Levanon and Tamar Geiger of Tel Aviv University report a new test for ovarian cancer that outperforms previous tests. They hope it will help screen women who are genetically predisposed to the disease.

The researchers used proteomics to search for signatures of cancer in uterine fluid. They compared samples from women with ovarian cancer having surgery in the course of treatment and from volunteers who had gynecological surgery for reasons unrelated to cancer, such as uterine fibroids or excessive bleeding.

Bodily fluids contain many proteins. Strong signals from the most common proteins can mask signals from smaller amounts of cancer-linked proteins that might also be present. To overcome that difficulty, researchers isolated microvesicles from the uterine fluid. Because microvesicles are shed from cells, they contain almost none of the signal-masking plasma proteins.

Using proteomics, the researchers compared thousands of proteins in uterine microvesicles from 12 healthy volunteers and 12 cancer patients. Then they used machine learning algorithms to search for patterns that could distinguish between the samples.

“We developed a diagnostic set of nine proteins that distinguishes women with ovarian cancer from healthy women with greater sensitivity and specificity than reported before,” Levanon said.

The researchers then tested the set’s accuracy in a cohort of 152 women, 37 of whom were known to have ovarian cancer. The test had 70 percent diagnostic sensitivity, meaning that it correctly detected cancer 25 of the 37 study participants who truly had cancer; and 76 percent specificity, meaning that it correctly identified about three out of every four healthy volunteers as healthy. It outperformed previous proteomics-based tests, which had less than 60 percent sensitivity.

The authors propose that their test may be useful for young women whose risk of developing ovarian cancer is known to be high. They also believe that the method of isolating microvesicles from bodily fluids to detect fainter cancer signals shows promise for other difficult-to-detect types of cancer.

Source:

http://www.asbmb.org

https://www.news-medical.net/news/20190315/New-proteomics-based-test-could-aid-in-early-detection-of-ovarian-cancer.aspx

US opioid prescriptions drop by a half but it’s not all good news

In a dramatic shift in physician behavior, the number of new opioid prescriptions issued each month in the US has taken a nosedive, to less than a half. However, the number of high-risk prescriptions remains worryingly high, according to researchers at Harvard University.

Patients who have never been prescribed opioids before or have been off them for six months or more are called opioid-naïve. In the new study, out of  20 million people who obtained at least one opioid prescription between 2012 and 2017, 10 million are now opioid-naïve.

In this group, the number of physicians who prescribed opioids went down by an astonishing 30% while there was a 54% decline in monthly prescriptions for opioid drugs, from 1.63 % of monthly patients to 0.75%, by the end of the study.

The number of overall and high-risk opioid prescriptions also decreased from March 2016 onwards – when the CDC guidelines were published.

The overuse of prescription opioid drugs has produced a massive epidemic of opioid misuse in the US, killing 70 000 people over the last year. Therefore, intensive efforts have been made, including pressure on lawmakers, to reduce the number of first-time opioid prescriptions, which often introduce patients or others to these drugs.

One major result was the U.S. Centers for Disease Control and Prevention (CDC) guidelines issued in March 2016, to curb risky opioid prescriptions. They recommend the use of other therapeutic modalities such as physical therapy and non-steroidal anti-inflammatory drugs (NSAIDs) wherever possible to help relieve pain.

High-risk prescriptions may be defined as a daily dose equivalent to 50 mg or more of morphine (50 morphine milligram equivalents (MME) a day). In the case of people with very severe pain, the maximum recommended dosage is 90 MME.

The guidelines recommend that no opioid at any dosage be prescribed for over three days, with one week being the absolute maximum.

The current study was based on the monthly analysis of 63.8 million privately insured patients aged 18 to 64 years between the years 2012 and 2017.

Despite the obvious reduction in opioid prescriptions, the actual percentage of high-risk prescriptions remained the same, surprisingly. About 115 000 of almost 16 million prescriptions fitted this category.

Even more worryingly, there were about 7700 prescriptions at doses above 90 MME – a dose which is associated with significant danger of both fatal and nonfatal overdose – despite the new guidelines.

Another group of healthcare providers apparently refused to prescribe opioids entirely, rather than take on the responsibility of using them appropriately. This fear is fueled, says Stefan Kertesz, an addiction specialist from the University of Alabama, by the high-powered attention on physicians from multiple stakeholders and regulatory bodies.

Kertesz commented, “In that situation, physicians tend to see the patient who might need opioids as a potential threat to the physician’s own professional survival.”

This “all-or-nothing approach” was not acceptable, since it could deprive some patients of adequate pain relief, suggested the study authors.

Another concern was that insurers sometimes misuse these guidelines to force patients to use lower opioid dosages, even for those who have achieved good pain control without addiction or misuse. In fact, Kertesz and other medical experts are lobbying for a confrontation with these agencies to safeguard patient well-being.

And finally, lack of access to prescription opioids could lead to an increase in heroin-overdose and related deaths over the following five years, before reducing new opioid addiction as intended.

It is well-known that most overdose deaths due to opioids occur with synthetic street drugs like fentanyl, though the initial exposure in a large number of cases is through prescription opioids.

The insurance claims were taken from the Blue Cross–Blue Shield (BCBS) Axis after removing all identifying details. This includes the widest collection of data relating to medical professional claims, commercial insurance claims and information about the cost of medical care.

Investigators looked at estimates of new monthly prescriptions issued to opioid-naïve individuals, those who were prescribed opioids in high doses or for prolonged periods, and the number of physicians who issued first-time opioid prescriptions to the opioid-naïve.

However, researchers could not comment on whether the clinical decision on opioids was appropriate in any case, as the data provided was non-specific.

The challenge we have in front of us is nothing short of intricate: curbing the opioid epidemic while ensuring that we appropriately treat pain. It’s a question of balancing the justified use of potent pain medications against the risk for opioid misuse and abuse.”

Nicole Maestas, Senior Investigator

The study shows that more thought needs to be put into the way a physician decides to prescribe or withhold opioids in a given clinical scenario, and also on the dose and duration of therapy, if given.

The study was published on March 14, in The New England Journal of Medicine.

Source:

Initial Opioid Prescriptions among U.S. Commercially Insured Patients, 2012–2017. NJEM.14^th March 2019.

https://www.news-medical.net/news/20190315/US-opioid-prescriptions-drop-by-a-half-but-ite28099s-not-all-good-news.aspx

Cell therapy could replace need for kidney transplants

Wake Forest Institute for Regenerative Medicine (WFIRM) scientists are working on a promising approach for treatment of chronic kidney disease — regeneration of damaged tissues using therapeutic cells.

By harnessing the unique properties of human amniotic fluid-derived stem cells, WFIRM scientists have demonstrated that the cells could potentially help recover organ function in a pre-clinical model of kidney disease.

“Our results indicate that this type of stem cell could be used as an off the shelf universal cell source and may provide an alternative therapeutic strategy for patients suffering from this chronic and debilitating disease,” said senior author James J. Yoo, M.D., Ph.D., a professor of regenerative medicine at WFIRM.

Study results were recently published online ahead of print in the journal Tissue Engineering Part A. This paper is one in a series the research team has published regarding therapies for the treatment of kidney disease. Known worldwide for their pioneering research on 3D bioprinting of tissues and organs, WFIRM researchers have also been tackling kidney disease and the shortage of organs in a variety of ways.

They were first in the world to identify and characterize stem cells derived from amniotic fluid in 2007 and have developed techniques for isolation and expansion of the cells. Amniotic fluid-derived stem cells can be used as a universal cell source because they have the ability to become different cell types as well as the ability to be anti-inflammatory, making them a potential source for regeneration. Unlike pluripotent and adult stem cells, amniotic fluid-derived stem cells are not as likely to provoke an immune system response. Additionally, their use does not lead to risks of tumors or ethical concerns, as with embryonic stem cells.

For this study, researchers found that amniotic fluid stem cells injected into a diseased kidney in a pre-clinical model led to improvement of kidney function based on measured waste levels after 10 weeks. Biopsy findings showed reduced damage to the cluster of capillaries where waste products are filtered from the blood.

“Our studies demonstrate that treatment with amniotic fluid stem cells had positive effects on functional improvement and structural recovery of the kidney,” said WFIRM Director Anthony Atala, M.D., and a co-author of the paper.

Kidney disease is a worldwide public health problem and can manifest in acute and chronic symptoms. More than 30 million American adults are affected by the disease and millions more are at risk of developing it, according to the National Kidney Foundation. Transplantation is the only definitive treatment method that restores kidney function, but has its own challenges with rejection and life-long immunosuppression. There also are not enough donor organs to meet demand.

Sunil George, Ph.D., a WFIRM research fellow and co-author who has been a part of the studies, said further research is being pursued. “It remains to be seen whether injecting more cells or more efficient engraftment of the infused cells enhances improvement of organ function,” he said.

The study was supported, in part, by the State of North Carolina and WFIRM. The authors declare no competing interests.

Co-authors also include: Mehran Abolbashan, Tae-Hyoung Kim, Chao Zhang, Julie Allickson, John D. Jackson, Sang Jin Lee and In Kap Ko, all of WFIRM.

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Story Source:

Materials provided by Wake Forest Baptist Medical Center. Note: Content may be edited for style and length.

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Journal Reference:

1. Sunil George, Mehran Abolbashari, Tae-Hyoung Kim, Chao Zhang, Julie Allickson, John D. Jackson, Sang Jin Lee, In Kap Ko, Anthony Atala, James J Yoo. Effect of Human Amniotic Fluid Stem Cells on Kidney Function in a Model of Chronic Kidney Disease. Tissue Engineering Part A, 2019; DOI: 10.1089/ten.TEA.2018.0371

https://www.sciencedaily.com/releases/2019/03/190314123215.htm

Popular Spice Rivals Stimulant for ADHD

The popular and expensive spice saffron (Crocus sativus L), appears to be as effective as the stimulant methylphenidate (MPH) in treating symptoms in youngsters with attention deficit hyperactivity disorder (ADHD), new research suggests.

In a randomized 6-week trial, a team of investigators from Tehran University of Medical Sciences in Iran, found there were no significant differences in efficacy or adverse events in the saffron vs MPH group.

“From this preliminary study, the main point is that we can consider saffron as an alternative [to stimulants] in patients with ADHD,” senior author Shahin Akhondzadeh, PhD, FBPhS, DSc, professor of clinical psychopharmacology, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Iran, told Medscape Medical News.

“Short-term efficacy of saffron demonstrated the same efficacy as methylphenidate, although larger, controlled studies with longer treatment periods are necessary to verify the findings,” he said.

The study was published online February 11 in the Journal of Child and Adolescent Psychopharmacology.

Empty Place

MPH, which is commonly used to treat ADHD, has many side effects, including loss of appetite, sleep disturbances, and nausea, the authors note.

Moreover, approximately 30% of children do not respond to MPH, leading to a search for nonstimulant strategies.

“Many antidepressants have been used as alternatives to stimulants in patients with ADHD that cannot tolerate Ritalin or do not respond to Ritalin,” Akhondzadeh said.

However, antidepressants are also associated with adverse events, with results that are “often unsatisfactory,” the authors note.

This leaves an “empty place to be filled by alternative medications, in particular herbal medications,” they add.

Saffron has traditionally been used for a variety of medicinal purposes, including its antispasmodic, antiseptic, anticancer, and anticonvulsant effects.

Saffron and its active constituents appear to increase the reuptake inhibition of dopamine and norepinephrine and are N-methyl D-aspartic acid (NMDA) receptor antagonists and GABA-α agonists.

“As you may know, my country is the main producer of saffron and about 90% of saffron is from Iran — indeed, saffron is a Persian herb with history as long as the Persian Empire,” Akhondzadeh noted.

“There are solid documents in the Persian traditional medicine about the psychotropic effects of saffron, but we need evidence-based medicine in traditional medicine as well.

“My research group at Roozbeh Psychiatry Hospital has studied the psychotropic effects of saffron since early 2000, and we have documented its antidepressant effects,” he added. …

https://www.medscape.com/viewarticle/910205

Neurocrine treatment of congenital adrenal hyperplasia gets orphan status

The FDA granted orphan designation to Neurocrine Biosciences’ treatment of congenital adrenal hyperplasia, according to a post to the agency’s website

https://thefly.com/landingPageNews.php?id=2880142

AHRQ launches app to help patients prepare for medical visits

Patients often only have about 15 minutes with their doctors during an office visit and they often walk in unprepared for what questions they want their doctor to answer about their medical problem or treatment.

To help patients prepare for their medical visits, the Agency for Healthcare Research and Quality (AHRQ) developed a new consumer mobile app that builds off the agency’s “Question Builder” online tool.

The Question Builder app, which is available at no charge for smartphones, tablets and laptop computers on iTunes and Google Play, aims to help patients organize questions and other information prior to medical visits.

The app was developed with input from consumers and clinicians, according to AHRQ.

“Consumers liked the ability to have questions and other information at their fingertips during medical visits, while doctors, nurses and other clinicians said that better-prepared patients would lead to more effective and efficient visits and potentially more accurate diagnoses and better outcomes,” the agency said in a release.

“Patients can get better care by preparing to ask questions about their care and communicating effectively with their doctors, nurses and other providers,” Jeff Brady, M.D., who directs AHRQ’s Center for Quality Improvement and Patient Safety, said in a statement. “Asking questions to make sure patients understand instructions and other aspects of their care can help reduce the chance of missed diagnoses, identify the right tests that are needed, and avoid unnecessary hospital stays.”

Through the app, patients can input details of their upcoming appointments, such as date and reason for the visit, and then choose questions they want to ask their doctor, starting with a list to prompt them with commonly asked questions in different situations. To talk to a doctor about medical tests, the app prompts patients to ask questions such as: How accurate is the test and what do I need to do to prepare for the test?

Patients can then use the app to email information to themselves or others for reference or can use the app to make notes during the medical visit. The app organizes content and questions by type of medical encounter, such as a medical visit or preparing for surgery, and offers consumer education materials and videos about the importance of asking questions and sharing information.

There’s also a camera option that allows patients to document visual information such as a skin rash, upload insurance or prescription medication information, and other photo-enabled features.

According to AHRQ, information entered into the Question Builder app resides on the user’s own device. The content is accessible via phone, tablet or laptop computer on both the iOS and Android operating systems.

https://www.fiercehealthcare.com/tech/ahrq-launches-app-to-help-patients-prepare-for-medical-visits

Diagnostic errors compounded by EHRs still No. 1 patient safety concern

• For the second year in a row, diagnostic errors and improper management of test results in EHRs top ECRI Institute’s list of patient safety concerns facing healthcare leaders. The list is intended as a starting point for organizations to review their patient safety records and set priorities for improvement.
• Other major issues include overuse of antibiotics, clinician burnout and the growing but loosely regulated use of mobile health technologies in the home, according to the 2019 Top 10 Patient Safety Concerns list.
• “We have to recognize the limits of current technology and ensure that we have processes in place to close the loop on diagnostic tests,” William Marcella, executive director of operations and analytics for ECRI Institute’s Patient Safety Organization, said in a statement. “This safety issue cuts across acute and ambulatory settings, requiring teamwork across the health system.”

Patient safety is a major concern for hospitals and health systems, impacting patient outcomes as well as a healthcare facility’s quality, reputation and financials as more payers reimburse for value rather than volume.

Diagnostic errors once again topped ECRI’s list of patient safety challenges this year, released in conjunction with National Patient Safety Awareness Week. Part of the problem is EHRs, which help to track test results and flag issues, but can’t provide a diagnosis, ECRI notes. Still, providers must document patients’ diagnoses, treatments and follow-up plans in EHRs so that future clinicians can understand and act on the information.

To fight antibiotic resistance, which claimed the second spot on the list, ECRI recommended providers ask four questions before administering a drug: Does the patient’s infection respond to antibiotics? If the answer is yes, is the patient getting the right antibiotic, dose and route of administration? Would a more targeted antibiotic work better? How long should the patient receive the antibiotic?

To reduce burnout, experts suggested organizations look beyond EHRs and address provider concerns about workload, performance criteria and poor resource allocation on a system-wide scale. “Leadership must strive to make providers feel they are treated as human beings, whose opinions and abilities are valued, rather than as cogs in a wheel,” the report says.

The increasing use of mobile health technologies brings with it a number of safety concerns, from lack of regulation to ensuring data are accurately transmitted to providers and patients actually use the device, according to the report. To improve safety, organizations should establish steps for informing providers when user errors occur or devices go silent. They also need protocols for identifying patients who will benefit from these devices and train providers and patients on how to use them.

The report also shines a light on behavioral health, noting provider unease and inexperience can lead to overlooking patients’ needs or exacerbation of symptoms. Efforts to address the issue include establishing behavioral emergency response teams within hospitals and additional training for providers.

Rounding out the list of top patient safety concerns are problems related to medical staff’s development and maintenance of skills, standardization of safety efforts across large health systems, detection of changes in a patient’s condition, early recognition of sepsis across the care continuum and infections from peripherally inserted IV lines.

Recommended Reading:

•  ECRI Institute DIAGNOSTIC ERRORS AND TEST RESULTS TOP ECRI INSTITUTE’S PATIENT SAFETY LIST

https://www.healthcaredive.com/news/diagnostic-errors-compounded-by-ehrs-still-no-1-patient-safety-concern/550304/