Physicians are prescribing more opioid painkillers than ever before to patients undergoing common surgeries, according to new research from the department of Anesthesiology and Critical Care at the Perelman School of Medicine at the University of Pennsylvania. Their work is published online simultaneously with a major new guideline from the Centers for Disease Control and Prevention (CDC) that calls on physicians to avoid over-prescription of opioids for surgical patients and other patients with painful conditions.
Opioid abuse and addiction is a growing concern in the U.S. with the National Institute on Drug Abuse estimating that approximately 2.1 million Americans suffer from substance use disorders related to prescription opioid pain relievers and an estimated 467,000 Americans are addicted to heroin, with increasing recognition of the strong relationship between opioid use and heroin abuse.
The new study, which included researchers from the University of Toronto, analysed insurance claims from 2004 through 2012 for 155,297 adults undergoing four common outpatient surgeries-carpal tunnel repair, laparoscopic gall bladder removal, some minimally invasive knee surgeries, and hernia repair. In an analysis of patients who had not received an opioid prescription in the six months preceding surgery, the researchers observed that four out of every five patients in the study filled a prescription for an opioid pain medication within the seven days after surgery. The percentage of patients who got those drugs increased over for the period studied all four surgical procedures.

Most notably, the amount of opioid medication dispensed to patients after surgery also increased markedly between 2004 and 2012 for all procedures studied. Among patients undergoing knee arthroscopy, for example, the investigators estimated a greater than 18 percent increase in the average total amount of opioid dispensed, driven by a change in the average daily dose.
‘These data show us a concerning trend,’ said the study’s senior author, Mark Neuman, MD, MSc, an assistant professor of Anesthesiology and Critical Care and director of the Penn Center for Perioperative Outcomes Research and Transformation (Penn CPORT). ‘The growth we observe over time in opioid prescribing after surgery occurs against the backdrop of a major public health crisis of prescription opioid abuse. Additional work is needed to understand how postoperative opioid prescribing patterns might play into this epidemic, and to define better strategies for treating postoperative pain safely and effectively in the future.’
The CDC’s guidelines address pain management outside of active cancer treatment, palliative care, and end-of-life care, recommending nonopioid therapy for the treatment of chronic pain, stating that opioids should be reserved for situations where the benefits for pain and function are expected to outweigh the risks. The guidelines also recommend that clinicians establish treatment goals before prescribing opioids and address how opioids can be discontinued if benefits do not outweigh risks. In addition, the CDC recommends that clinicians prescribe the lowest effective dosage, carefully reassessing benefits and risks when considering increasing dosage and evaluate the benefits and harms of continued opioid therapy with patients every three months or more frequently for high-risk combinations or dosages.

Penn Medicine http://tinyurl.com/gt5cjqw

For the first time, researchers led by Tufts University engineers have integrated nano-scale sensors, electronics and microfluidics into threads – ranging from simple cotton to sophisticated synthetics – that can be sutured through multiple layers of tissue to gather diagnostic data wirelessly in real time. The research suggests that the thread-based diagnostic platform could be an effective substrate for a new generation of implantable diagnostic devices and smart wearable systems.

The researchers used a variety of conductive threads that were dipped in physical and chemical sensing compounds and connected to wireless electronic circuitry to create a flexible platform that they sutured into tissue in rats as well as in vitro. The threads collected data on tissue health (e.g. pressure, stress, strain and temperature), pH and glucose levels that can be used to determine such things as how a wound is healing, whether infection is emerging, or whether the body’s chemistry is out of balance. The results were transmitted wirelessly to a cell phone and computer.

The three-dimensional platform is able to conform to complex structures such as organs, wounds or orthopaedic implants.

While more study is needed in a number of areas, including investigation of long-term biocompatibility, researchers said initial results raise the possibility of optimizing patient-specific treatments.

‘The ability to suture a thread-based diagnostic device intimately in a tissue or organ environment in three dimensions adds a unique feature that is not available with other flexible diagnostic platforms,’ said Sameer Sonkusale, Ph.D., corresponding author on the paper and director of the interdisciplinary Nano Lab in the Department of Electrical and Computer Engineering at Tufts School of Engineering. ‘We think thread-based devices could potentially be used as smart sutures for surgical implants, smart bandages to monitor wound healing, or integrated with textile or fabric as personalized health monitors and point-of-care diagnostics.’

Tufts University’s School of Engineering now.tufts.edu/news-releases/researchers-invent-smart-thread-collects-diagnostic-data-when-sutured-tissue

A simple phone checklist can help detect tell-tale changes in the health status of people receiving nonmedical home care, according to the findings of a pilot study led by investigators at Harvard Medical School.

Results of the research are based on a program that requires home-care aides to record changes in status during a telephone clockout at the end of each shift.

The research was conducted in collaboration with Right at Home, a senior home care provider, and ClearCare, a company that provides a software platform for homecare agencies.

Analysis of the data captured over a six-month period across 22 Right at Home agencies reveals that changes in clinical status are relatively common — occurring in 2 percent of all caregiver shifts and affecting, on average, 2 percent of recipients. The majority of changes were in behaviour (17 percent) and skin condition (16 percent), followed by changes in eating or drinking behaviour (14 percent) and ability to stand or walk (9 percent).

The results, researchers said, underscore the potential of real-time monitoring systems to spot problems and avert complications before they escalate enough to require hospitalization. Indeed, over the course of the six-month trial, 14 percent of the home-care recipients were hospitalized.

Recipients of non-medical home care often have chronic health conditions that lead to hospitalizations, some of which may be preventable.

The research team cautioned that whether the real-time monitoring system could, in fact, prevent hospitalizations and reduce cost of care remains unknown. That, they said, is the subject of an ongoing randomized trial across 400 home-care locations in the United States. However, the research team said, the fact that a basic phone questionnaire could capture important indicators in clinical status points to the value of harnessing simple technologies to monitor those receiving care at home.

‘Millions of elderly Americans receive supportive home-care services each year, and many of them require frequent hospitalizations, so we set out to determine whether a simple real-time checklist could help improve outcomes and lower health care spending,’ said study leaderDavid Grabowski, Ph.D., professor of health care policy at Harvard Medical School. ‘Our results are a first step to answering that question.’

Under the pilot program, home caregivers were required to do a phone clock out at the end of their shifts. Caregivers receive an automated phone message prompting them to report any changes in health status. The message included a list of questions pertaining to changes in mental, neurologic, gastrointestinal, urinary and other indicators. Any changes reported via the automated system were immediately dispatched to a manager at the home-care agency office for further assessment and triage. The care manager determined whether the condition required closer monitoring, a change in care, a call into the doctor’s office or all of the above. The idea, researchers said, is to prevent complications before they become grave enough to require hospitalization.

Patients who may benefit the most include those with chronic conditions such as diabetes, neurologic disorders or cardiovascular disease, in whom even seemingly innocuous changes could spell bigger trouble. That theme, researchers said, emerged clearly in a series of interviews with home-care workers. For example, one manager relayed the story of a person with diabetes whose caregiver reported a foot ulcer through the phone-based checklist. Normally, that injury would not have been reported until the end of the week, but because of the prompt alert, the care manager reached out to the patient’s nurse, who initiated treatment immediately. One week later, the wound had healed. Sores, wounds and injuries are particularly dangerous in people with diabetes and can lead to rapid decay of tissue and, in some cases, limb amputations.

EurekAlert www.eurekalert.org/pub_releases/2016-08/hms-pcc081116.php

Ultrasound technology is taking to the skies with the Essex & Herts Air Ambulance Trust, a charity that provides a free, life-saving Helicopter Emergency Medical Service for the critically ill and injured of Essex, Hertfordshire and the surrounding areas. Stuart Elms, Clinical Director of the Trust, explained: ‘We operate two helicopters crewed by full-time pre-hospital care doctors and critical care paramedics who can be rushed to the scene of an incident with highly specialized and advanced life-saving equipment and pharmacy. As part of our practice, we are moving towards using ultrasound for management of cardiac arrest and advanced life support. Working with expert sites such as the Essex Cardiothoracic Centre at Basildon, Harefield Hospital and SonoSite, our aim is to train our critical care paramedics to use point-of-care ultrasound, allowing us to tailor our cardiac care even more accurately.’ ‘SonoSite is a world leader in point-of-care ultrasound, and its hand-carried iViz instrument lends itself perfectly to pre-hospital use, both in the aircraft and at the scene. The system is small and portable with a good screen that gives a brilliant view, and can be used one handed. The preset views allow rapid set-up and scanning, and are supported by a training mode that allows comparison of normal and abnormal pathology. Ultimately, we also hope to take advantage of the system’s mobile computing capacity to automatically upload data to electronic patient report forms prior to arrival at the hospital. Our aim is to make as much use of ultrasound as we currently do of stethoscopes – whether they are cardiac, medical or trauma patients – helping to improve outcomes.’

www.sonosite.com

For medics on the battlefield and doctors in remote or developing parts of the world, getting rapid access to the drugs needed to treat patients can be challenging. Biopharmaceutical drugs, which are used in a wide range of therapies including vaccines and treatments for diabetes and cancer, are typically produced in large, centralized fermentation plants. This means they must be transported to the treatment site, which can be expensive, time-consuming, and challenging to execute in areas with poor supply chains.
Now a portable production system, designed to manufacture a range of biopharmaceuticals on demand, has been developed by researchers at MIT, with funding from the Defense Advanced Research Projects Agency (DARPA).
In a paper the researchers demonstrate that the system can be used to produce a single dose of treatment from a compact device containing a small droplet of cells in a liquid.

In this way, the system could ultimately be carried onto the battlefield and used to produce treatments at the point of care. It could also be used to manufacture a vaccine to prevent a disease outbreak in a remote village, according to senior author Tim Lu, an associate professor of biological engineering and electrical engineering and computer science, and head of the Synthetic Biology Group at MIT’s Research Laboratory of Electronics.
‘Imagine you were on Mars or in a remote desert, without access to a full formulary, you could program the yeast to produce drugs on demand locally,’ Lu says.

The system is based on a programmable strain of yeast, Pichia pastoris, which can be induced to express one of two therapeutic proteins when exposed to a particular chemical trigger. The researchers chose P. pastoris because it can grow to very high densities on simple and inexpensive carbon sources, and is able to express large amounts of protein.

‘We altered the yeast so it could be more easily genetically modified, and could include more than one therapeutic in its repertoire,’ Lu says.
When the researchers exposed the modified yeast to estrogen β-estradiol, the cells expressed recombinant human growth hormone (rHGH). In contrast, when they exposed the cells to methanol, the yeast expressed the protein interferon.
The cells are held within a millimeter-scale table-top microbioreactor, containing a microfluidic chip, which was originally developed by Rajeev Ram, a professor of electrical engineering at MIT, and his team, and then commercialized by Kevin Lee – an MIT graduate and co-author – through a spin-off company.
A liquid containing the desired chemical trigger is first fed into the reactor, to mix with the cells.

Inside the reactor, the cell-and-chemical mixture is surrounded on three sides by polycarbonate; on the fourth side is a flexible and gas-permeable silicone rubber membrane. By pressurizing the gas above this membrane, the researchers are able to gently massage the liquid droplet to ensure its contents are fully mixed together.
‘This makes sure that the one milliliter (of liquid) is homogenous, and that is important because diffusion at these small scales, where there is no turbulence, takes a surprisingly long time,’ says Ram, who was also a senior author of the paper.
Because the membrane is gas permeable, it allows oxygen to flow through to the cells, while any carbon dioxide they produce can be easily extracted.
The device continuously monitors conditions within the microfluidic chip, including oxygen levels, temperature, and pH, to ensure the optimum environment for cell growth. It also monitors cell density.
If the yeast is required to produce a different protein, the liquid is simply flushed through a filter, leaving the cells behind. Fresh liquid containing a new chemical trigger can then be added, to stimulate production of the next protein.
Although other research teams have previously attempted to build microbioreactors, these have not have not had the ability to retain the protein-producing cells while flushing out the liquid they are mixed with, Ram says. ‘You want to keep the cells because they are your factory,’ he says. ‘But you also want to rapidly change their chemical environment, in order to change the trigger for protein production.’

The researchers are now investigating the use of the system in combinatorial treatments, in which multiple therapeutics, such as antibodies, are used together.
Combining multiple therapeutics in this way can be expensive if each requires its own production line, Lu says.
‘But if you could engineer a single strain, or maybe even a consortia of strains that grow together, to manufacture combinations of biologics or antibodies, that could be a very powerful way of producing these drugs at a reasonable cost,’ he says.

MIT news.mit.edu/2016/portable-device-produces-biopharmaceuticals-on-demand-0729