February 24, 2016

Sepsis, septic shock redefined in consensus statement

Updated definitions of sepsis and septic shock unveiled here Monday eliminate criteria previously used for diagnosis that, research has shown, are nonspecific and have led to missed diagnosis as well as overdiagnosis, researchers said.

The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3), made public at the Society for Critical Care Medicine (SCCM) 45th Critical Care Congress, were simultaneously published in the Journal of the American Medical Association.

The new definitions do away with the current use of two or more systemic inflammatory response syndrome (SIRS) criteria for sepsis diagnosis. Components of SIRS include tachycardia, tachypnea, hyperthermia or hypothermia, and elevated white blood count.

Led by Mervyn Singer, MD, of University College London, and Clifford Deutschman, MD, MS, of Hofstra-Northwell School of Medicine in New Hyde Park, NY, the international task force that developed the new definitions unanimously considered the requirement for two or more SIRS criteria to be unhelpful in the diagnosis of sepsis.

Recent studies have shown that SIRS symptoms occur in a large majority of hospitalized patients and are often associated with benign conditions.

The new definition for sepsis includes evidence for infection, plus life-threatening organ dysfunction, which is clinically characterized by an acute change of two points or greater on the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score.

Septic shock is now defined to include sepsis with fluid-unresponsive hypotension, serum lactate level greater than 2 mmol/L, and the need for vasopressors to maintain mean arterial pressure of 65 mm Hg or greater.

The bedside clinical scoring system is known as "quick SOFA" or qSOFA. The one in four (25%) patients in their analysis with two or more positive qSOFA symptoms accounted for 70% of sepsis patients, Seymour said.

The task force recommended that qSOFA criteria be used to prompt clinicians "to further investigate for organ dysfunction, to initiate or escalate therapy as appropriate, and to consider referral to critical care or increase the frequency of monitoring."

The revised task force recommendations define septic shock as a "subset of sepsis in which underlying circulatory, cellular and metabolic abnormalities are associated with a greater risk of mortality than sepsis alone."

Visit MedPage Today.

Senate clears way for approval of new FDA commissioner

The Senate has cleared the way for approval of President Barack Obama’s nominee for commissioner of the Food and Drug Administration.

Senators voted 80-6 Monday to end a Democratic filibuster of Obama’s pick to head the agency. Democratic presidential candidate Bernie Sanders and Sens. Joe Manchin of West Virginia and Ed Markey of Massachusetts had held up the nomination of Dr. Robert Califf in an effort to force the agency to be tougher on prescription drug prices and the abuse of opioid painkillers.

Califf, a prominent cardiologist and medical researcher at Duke University for more than 30 years, is now the No. 2 official at the FDA.

Manchin and Markey held a news conference before the vote blaming the FDA for enabling the opioid crisis. In 2014, U.S. deaths linked to misuse and abuse of prescription painkillers climbed to 19,000, the highest number on record, according to the Centers for Disease Control and Prevention. By its estimation, deaths tied to these drugs have risen more than four-fold since 1999 amid increased prescribing by U.S. doctors.

But in an unusual move as pressure mounted from the Senate, Califf announced earlier this month that the agency would rethink its approach. He pledged that the agency would add new warning labels to the most-commonly prescribed opioids and require new opioid drugs to go before an outside panel of independent reviewers.

As head of the FDA, Califf would inherit a raft of projects and potential challenges, including unfinished tobacco regulations and food safety and labeling reforms. (Associated Press) Visit ABC News for the report.

FDA recommends healthcare facilities transition from Custom Ultrasonics endoscope washer/disinfectors

The FDA is revising its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics regarding its November 2015 Recall Order.

On November 12, 2015, in accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics (Consent Decree), FDA ordered Custom Ultrasonics to recall, at its expense, all of its Automated Endoscope Reprocessors (AERs). On November 24, 2015, Custom Ultrasonics submitted a recall strategy to the FDA, which the Agency found inadequate. Custom Ultrasonics has to date made no additional proposals to FDA to recall its AERs.

On January 29, 2016, the FDA sent a letter to Custom Ultrasonics reinforcing the terms of the Recall Order and requiring Custom Ultrasonics to remove its AERs from the market. The FDA further notified Custom Ultrasonics that it could take additional measures under the Consent Decree should Custom Ultrasonics fail to initiate or diligently implement the recall or take other required actions.

Because Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the Agency continues to recommend that healthcare facilities using Custom Ultrasonics AERs transition to alternative methods to reprocess flexible endoscopes as soon as possible, as emphasized in its November 13, 2015 Safety Communication.

Facilities are advised to:

Identify and transition to alternate methods to reprocess flexible endoscopes, such as manual high-level disinfection, liquid chemical sterilization, alternative AERs, or other cleaning and sterilization methods according to the endoscope manufacturers’ reprocessing instructions.

Before transitioning to an alternative method, be sure that the endoscopes your facility uses are compatible with the alternative method by referring to the endoscope manufacturer’s reprocessing instructions.

Visit the FDA for the full safety recall.

CDC investigating 14 new potential cases of sexually transmitted Zika

Federal and state health officials are investigating 14 new reports of potential sexual transmission of the Zika virus in the United States, including several cases involving pregnant women, the Centers for Disease Control and Prevention disclosed Tuesday.

In at least two of the cases, a Zika infection was confirmed in women whose only known risk factor was sexual contact with an ill male partner who recently had returned from one of the nearly three dozen countries where the virus has now spread. Four other women have tested positive for Zika in preliminary lab tests but are awaiting final confirmation. The CDC said the eight other cases remain under investigation.

"We were surprised, given the numbers actively being investigated," Anne Schuchat, the CDC's deputy director, said in an interview. "We were concerned enough that we thought it was important to share that information ... We are seeing more than we expected to see."

Even if several of the reports are ultimately disproved, the confirmed cases suggest that sexual transmission of the virus is far more possible than previously thought. That dynamic will only further complicate public health officials' efforts to stop Zika.

Officials said the same scenario played out in most, if not all, of the suspected cases: A man who had traveled to a Zika-affected area returned the United States and had sex with a female partner, who soon began to display symptoms consistent with Zika.

Scientists still believe that mosquitoes are the main means of transmission for the virus, which has spread explosively throughout the Americas in recent months and is suspected of being linked to serious birth defects and a rare autoimmune disease. Prior to February, only one case of sexual transmission had been documented.

Both the CDC and the World Health Organization have issued guidelines urging the use of condoms to prevent the spread of the virus, particularly when a woman is pregnant or might become pregnant. Officials have also recommended couples consider abstaining from sex for the duration of a pregnancy if the male partner recently traveled to a Zika-affected country.

The CDC on Tuesday reiterated those recommendations, saying that "these new reports suggest sexual transmission may be a more likely means of transmission for Zika virus than previously considered." The agency also has suggested that women who are pregnant or plan to become pregnant should avoid traveling to Zika-affected areas.

Visit the Washington Post for the report.

Texas hospitals develop first rapid detection test for Zika virus

With the Zika virus starting to spread to other countries, medical researchers have stepped up their efforts to discover a better way to test potential infections and even a vaccine that would effectively protect people from the dreaded disease.

Researchers from Texas Children's and Houston Methodist hospitals announced the creation of the first rapid test in the United States meant to diagnose people suspected of being infected with the Zika virus.

The new diagnostic procedure is designedto scan the blood, urine, spinal fluid and amniotic fluid from a person to find out if they contain traces of the virus' genetic material. The developers hope that it would be able to cut down the time it typically takes to make a conclusive diagnosis from one month to just a day.

While Texas Children's and Houston Methodist will make the rapid Zika virus test available to their own patients for now, the two hospitals plan to offer the procedure to patients of other medical facilities as well.

"We really pulled out all the stops to get this test generated," Dr. James Musser, head of the pathology and genomic medicine department at Houston Methodist, said.

Kathy Barton, spokeswoman for the Health Department of Houston, said on Monday that their researchers are finalizing the certification of their own Zika virus diagnostic procedure.

Previous testing for the illness involved sending samples to the U.S. Centers for Disease Control and Prevention (CDC) or to public health agencies on the state level that have the ability to detect the Zika virus.

Some hospitals have been trying to develop their own diagnostics for the Zika virus. Musser said he expects these organizations to announce their disease testing soon.

Meanwhile, scientists at the University of Texas Medical Branch (UTMB) in Galveston are now working closely with officials from the Brazilian government for a potential vaccine for the Zika virus, which has devastated much of the South American nation and other nearby countries.

The team has been studying the mosquito-borne disease since the 1960s and has even issued a warning about the dangers of the illness as early as 2009.

Visit Tech Times for the announcement.

Blood test could transform tuberculosis diagnosis, treatment in developing countries

A simple blood test that can accurately diagnose active tuberculosis could make it easier and cheaper to control a disease that kills 1.5 million people every year.

Researchers at the Stanford University School of Medicine have identified a gene expression "signature" that distinguishes patients with active tuberculosis from those with either latent tuberculosis or other diseases.

The technology fills a need identified by the World Health Organization, which in 2014 challenged researchers to develop better diagnostic tests for active TB.

Globally, tuberculosis infects 9.6 million new patients each year and kills 1.5 million. Yet the disease remains difficult to diagnose. "One-third of the world's population is currently infected with TB. Even if only 10 percent of them get active TB, that's still 3 percent of the world's population -- 240 million people," said Purvesh Khatri, PhD, assistant professor of medicine and senior author of the paper.

Traditional diagnostic methods, such as the skin prick test and interferon assays, can't separate patients with active TB from those who are no longer sick or have merely been vaccinated against TB (and most countries vaccinate everyone against TB). These older diagnostics can miss a case of TB in patients with HIV.

A common way to test for TB is to look for the disease-causing bacterium in sputum samples coughed up by patients. But sometimes it's hard for people to produce sputum on demand, said research associate Tim Sweeney, MD, PhD, first author of the paper. And the sputum test is almost useless for monitoring how someone is responding to treatment. As people start to get better, they can't produce sputum for the test.

The new test developed in the Khatri lab works on an ordinary blood sample and removes the need to collect sputum. It can signal a TB infection even if the individual also has HIV. And it won't give a positive response if someone only has latent TB or has had a TB vaccine. It also doesn't matter which strain of TB has infected a person, or even if it has evolved resistance to antibiotic drugs. The test works in both adults and children.

WHO has called for a test that would give a positive result at least 66 percent of the time when a child has active TB. The Khatri test is 86 percent sensitive in children. And if the test comes up negative, it's right 99 percent of the time. That is, of 100 patients who test negative with the Khatri test, 99 do not have active TB.

The requirements of the test are simple enough that it can potentially be done under relatively basic field conditions in rural and undeveloped areas of the world. Any hospital should be able to perform the test. Villages without electricity could likely use ordinary blood samples and a solar-powered PCR machine, which multiplies strands of DNA, to accurately test people for active TB.

The new test not only accurately distinguishes patients who have active tuberculosis, it could also be used to monitor patients to see if they are getting better and how well they are responding to different treatments. Thus, it can be used not only for diagnosis and to inform treatment, but also to study the effectiveness of different treatments. The test's hugely accurate negative response would be especially helpful in monitoring the effectiveness of treatments during clinical trials, said Khatri.

The work is an example of Stanford Medicine's focus on precision health, the goal of which is to anticipate and prevent disease in the healthy and precisely diagnose and treat disease in the ill.

Visit EurekAlert for the study.

Researchers find more breast cancer patients opting formastectomy

More women in the United States are undergoing mastectomies, even though the overall rate of breast cancer has remained stable, a new federal government report reveals.