New tool helps predict mortality risk in dementia patients

Researchers have developed a A new tool that predicts risk of death and admission to a long-term care facility for patients with dementia may help conversations between health care providers, patients and their families. The research has been published in the CMAJ - Canadian Medical Association Journal.

The recent tragic outbreaks of COVID-19 in long-term care homes highlight the need to have care discussions with residents and their caregivers.

"The majority of residents in long-term care homes have been diagnosed with dementia. Our study shows that the survival of many people with dementia is poor. It may be that many would choose care that focuses on comfort care and quality of life should they become acutely ill," says Dr. Peter Tanuseputro, a family physician and researcher with the Bruyère Research Institute, the Ottawa Hospital Research Institute and ICES, Ottawa, Ontario.

 

We have developed a tool that asks simple questions about a person at the time of dementia diagnosis and translates it to the chance of dying and of entering a nursing home over the next 5 years. This information can be used in conversations about what to expect," says Dr. Tanuseputro. "For newly diagnosed dementia patients and their families, personalized information about their trajectory may be helpful to plan for the future, including advance care planning and planning for additional supports."

The study used linked data from ICES on more than 108 000 people living in the community in Ontario who were newly diagnosed with dementia from 2010 through 2012.

 Researchers found that more than half of individuals (55%) died within 5 years -- comparable to many cancers -- and almost half of those who died (28%) lived in institutions. Only 1 in 4 people were still alive and living in the community 5 years after diagnosis.

Older age, male sex and presence of chronic obstructive pulmonary disease (COPD), congestive heart failure and kidney failure at the time of diagnosis of dementia were the most important factors that predicted death and admission to long-term care. The impact of organ failure on prognosis in people with dementia has not been well documented in other studies.  

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New tool shows potential to predict developmental toxicity in humans with high accuracy

Recently published results from an evaluation of 1,065 chemical and drug substances using the devTOX quickPredict (devTOXqP) screening platform developed by Stemina Biomarker Discovery, Inc. demonstrated the platform's ability to predict developmental toxicity in humans with high accuracy using a cell-based test. In a peer-reviewed article published in Toxicological Sciences, scientists from the U.S. Environmental Protection Agency (EPA) reported that Stemina's devTOXqP test predicted the potential for developmental toxicity in a blinded set of chemicals and drugs from the agency's ToxCast TM program with an accuracy of 82%, where there was clear evidence of toxicity in humans or in animal studies. The agency's research suggests that devTOXqP is a useful tool for predicting developmental toxicants in humans and reducing the need for animal testing.

 Through this EPA research, the devTOXqP test demonstrated its potential to detect developmental toxicity across a wide variety of chemicals and pharmaceutical compounds. In addition to helping meet the EPA's goal of reducing the use of animals in testing chemicals, devTOXqP offers the only species-specific, commercially available platform for evaluating a drug or chemical's potential to cause birth defects in the developing human embryo. We believe this test fits well into global initiatives such as Tox21 and REACH that are seeking to reduce and refine the number of animals used for toxicity testing."     Elizabeth Donley, J.D., M.B.A., M.S., chief executive officer of Stemina

The potential of chemical substances to cause prenatal developmental toxicity is commonly assessed based on observations of fetal malformations and variations in rodent or rabbit studies. Such animal studies are costly, resource-intensive, and the results seen in one species often differ from those seen in other species or from those that might be relevant in humans. Some of the most promising non-animal testing alternatives make use of the self-organizing potential of embryonic stem cells to recapitulate developmental processes that may be sensitive to chemical exposure. The Stemina devTOXqP test uses human embryonic stem cells (hESCs) or human induced pluripotent stem cells (iPSCs) to predict developmental toxicity based on changes in cellular metabolism following drug or chemical exposure. The iPSC is a reprogrammed cell that is able to recapitulate development into all cell types like hESCs but does not come from an embryo.

In the EPA study, 1,065 ToxCast chemicals were first screened in single-concentration for the targeted biomarkers, the ratio of the amino acids ornithine (ORN) to cystine (CYSS), in response to the tested compound. Of the screened chemicals, 17% were predicted by the Stemina assay to cause developmental toxicity. These compounds were then tested at eight concentrations in the devTOXqP test to determine the exposure level at which the compound was considered to be toxic. The assay performance reached 82% accuracy with 67% sensitivity and 84% specificity. The sensitivity of the assay improved when more stringent evidence of toxicity was applied to the animal studies. Statistical analysis of the most potent chemical hits on specific biochemical targets in ToxCast provided insights into the mechanistic underpinnings of the targeted endpoint of the devTOXqP platform. The researchers found that an imbalance in Ornithine/Cystine was highly predictive of a chemical's potential to disrupt the development of an embryo or fetus, halting the pregnancy or producing birth defects.

"The extensive nature of this research helps to define the applicability domain of the test -- in other words, where does it perform well and where will it need to be paired with other endpoints to generate a better understanding of the potential to cause birth defects", said Jessica Palmer, M.S., associate director of toxicology at Stemina. "This is just the first step in our longer-term goal of moving away from a reliance on animal tests to predict human response and provides a foundation for building integrated testing systems focused on human cells."

To address concerns about the effects of drugs and chemicals on our health, we need more human-relevant methods to assess toxicity. We encourage regulatory agencies and companies to consider how the devTOXqP test can improve safety and help reduce animal testing."    Kristie Sullivan, M.P.H., vice president for research policy at the Physician's Committee for Responsible Medicine.

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Novel tool that measures cell strength may help identify drugs for asthma, hypertension

Researchers have developed a new tool that can measure the physical strength of individual cells 100 times faster than current technologies.

It is the first high-throughput tool that can measure the strength of thousands of individual cells at a time, according to the new study, as described in a journal.

"We took a fresh approach to identify molecules that could serve as drugs to meet an unmet need for new treatments to treat or cure chronic disease," the co-author and professor of medicine was quoted as saying in a news release.

The new device, called fluorescently labeled elastomeric contractible surfaces, or FLECS, could make it easier and faster to test and evaluate new drugs for diseases associated with abnormal levels of cell strength, including hypertension, asthma and muscular dystrophy. It may also open new avenues for biological research into cell-force.

Cells use physical force for essential biological functions. Disruptions in a cell's ability to control the levels of force they exert can lead to diseases or loss of important bodily functions.

"Apart from demonstrating the feasibility of screening compounds for drug discovery, we also discovered that the conventional notion that increases in calcium levels within a cell are essential to control cell shortening or migration that is important in asthma or cancer metastasis was incorrect," the author said. "Our observations using this novel platform offer a new paradigm regarding cell activation and approaches to screen molecules to target such processes."

According to the study, the device's key component is a flexible rectangular plate with more than 100,000 uniformly spaced X-shaped micropatterns of proteins that are sticky, so that cells settle on and attach themselves to them.

The X's embedded in the plate are elastic, so they shrink whenever the cells contract. The X's are made fluorescent with a molecular marker to enable imaging and quantification of how much the shapes shrink.

To test the tool, the researchers analyzed drugs that make cells either contract or relax, using human smooth-muscle-cells which line the airways in the body. They also conducted additional testing to further demonstrate the device's versatility and effectiveness, according to a news release.

"Our tool tracks how much force individual cells exert over time, and how they react when they are exposed to different compounds or drugs," said a professor of bioengineering. "It's like a microscopic fitness test for cells with thousands of parallel stations." 

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New tool developed for diabetes patients at risk for low blood sugar emergencies

According to a recent research, a group of researchers have found and validated a practical tool for identifying diabetes patients who are at the highest risk for being admitted to an emergency department or hospital due to severe hypoglycemia, or very low blood sugar. 

Advances in care and improved treatment options have reduced the risk of long-term complications and death for more than 25 million who have diabetes, which is characterized by high blood sugar. 

A senior research scientist and the study's lead author, said, “Sometimes a person with diabetes is unaware that their blood sugar is dropping and can progress quickly into severe hypoglycemia, which has been associated with falls, automobile accidents, heart attacks, coma, and even death.”

Adding, “Hypoglycemia is often preventable with the proper clinical attention, and we believe this tool will help focus that attention on the patients who most need it.” 

With an estimated 100,000 hypoglycemia-related adverse events resulting in emergency room visits each year , hypoglycemia is now one of the most frequent adverse events in patients with type two diabetes. 

Older patients and those with a longer history of diabetes are particularly susceptible, noted the researcher.The study developed the hypoglycemia risk stratification tool by identifying 156 possible risk factors for hypoglycemia and collecting data from more than 200,000 patients with type two diabetes receiving care from a hospital. 

Using machine-learning analytical techniques, they developed a model to predict a patient's 12-month risk of hypoglycemia-related emergency department or hospital use.

The final model was based on six variables: number of prior episodes of hypoglycemia-related emergency department visits or hospitalizations; use of insulin; use of sulfonylurea (an oral medication commonly used to treat diabetes); severe or end-stage kidney disease; number of emergency room visits for any reason in the past year; and age. 

The researchers created a practical tool to categorize patients into high (greater than five percent), intermediate (one to five percent) or low (less than 1 percent) annual risk of hypoglycemia-related emergency department or hospital utilization. 

The  development of the tool for identifying patients at risk of hypoglycemia under their Safe Use Initiative, a collaborative effort to reduce adverse events related to medication use, including diabetes medications linked to an increased risk of hypoglycemia.

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New tool to detect cervical cancer

The menstrual pad test can become a stress-free screening method

Testing menstrual blood present on menstrual cloth can help detect human papilloma virus (HPV), which is one of the main causes of cervical cancer, researchers have found. The study was carried out on over 550 women aged 30 to 50 years at two rural populations.

Cervical cancer is a major public health problem and although there are cervical cancer screening tests, most rural women fear the test and see it as an unpleasant experience.

Samples testing

Over 190 eligible women were recruited for the study from two villages. The women who consented underwent HC2 testing to detect HPV. All the women, whether positive or negative for HPV, were asked to store their cloth pad used on the first day of period and immediately hand it over to the health worker. The collected menstrual cloth samples were sent for testing.

The DNA extracted from the dried menstrual blood was amplified and tested for HPV. Over 3% positive HPV cases were detected from this area (both HC2 and DNA study showed positive). They underwent further vaginal examination and treatment. Two cases of cervical lesions were also diagnosed.

Additional study

After satisfactory results from first area, another rural population with significantly better social indicators was studied. Over 360 women from 16 villages were selected for the study. However, the women were not tested for HPV but their menstrual blood was tested.

From this population, 4.9% cases were diagnosed as HPV positive using DNA tests. The HPV positive women and a few HPV negative women underwent vaginal examination, HC2 test and PAP smear test (another cervical cancer test).

The sensitivity of the menstrual pad HPV testing in the first and second area was 83% and 67%, respectively, and the specificity was 99% and 88% in the two areas. The reduced sensitivity at second area could be due to electricity failure in the health centre as the samples need to be continuously stored at -20⁰C.

According to the researchers, the menstrual pad DNA testing could be used instead of PAP smear test as PAP test has several limitations such as very low sensitivity of around 50% and the method of sample collection is both painful and invasive.

“Most of the women in these villages are daily wagers and do not want to waste a day for clinical screening. There is low participation in community screenings as they are shy and also fear the test. By using menstrual pad/cloth as a screening tool we can provide comfort and convenience to the participants,” says the Dr.  and the author of the paper.

By developing a simple method to mail the pads to the lab by participants itself, menstrual pad test can become a stress-free cervical cancer screening method, the authors write.

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