Clinical Briefs November 2010

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New Technology Allows Better Communication During Surgery

A new computerized, operating room control system called OR•Control, designed to allow better communication between clinical staff and also allow family members and friends to follow the progress of their loved ones through surgery, was recently introduced at the Michael DeBakey VAMC in Houston.

The system’s goal is to improve the effectiveness and efficiency of surgeries by coordinating and supporting members of the medical team. Using real-time location tracking technology, such as ultrasound, the control system automatically tracks and displays the status of all personnel, activities, and equipment related to a particular surgical procedure and then, continuously updates the facility’s surgical schedule.

The system creates a simple way for clinical staff to communicate in coordinating and prioritizing their activities to maintain schedules. This coordinated care and communication has resulted in more timely operations and better results for veterans undergoing surgery. Information displays and alerts are available throughout the facility and remotely via e-mail, cell phones, and other Web-enabled devices. Another important benefit of the system is that family members and friends are kept informed.

“This control system moves our operating room from after-the-fact, manual tracking processes of the 1970s into the 21st century,” said Dr David H Berger, MHCM, operative care line executive. “When schedules change, it is difficult to immediately calculate and then convey cascading effects to everyone who needs to know. This lack of real-time communication results in frustrated staff, late schedules, and unnecessary stress for veterans and their family members.”

When delays do occur, the system automatically adjusts the scheduled start time of the effected procedure, as well as calculates the ripple effect of these changes on the rest of the day’s schedule. The impact on staff and anesthesia assignments, future procedure times, and use of equipment are all determined automatically. Those changes are immediately displayed for everyone to see.

FDA: Orthopedic Device Should Never Have Been Approved for Market

FDA last month ruled that an orthopedic device used in the knee should not have been cleared for marketing in the US. The announcement follows a re-evaluation of the scientific evidence that was undertaken after a September 2009 agency report identified problems in the agency’s review of the device.

To correct the error, FDA has begun the process of rescinding the product’s marketing clearance. Before beginning this process, the FDA has asked the product’s manufacturer, ReGen Biologics Inc, to meet with the agency to discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness.

The device, called Menaflex Collagen Scaffold, was cleared for marketing by the FDA in December 2008 for the repair and reinforcement of the meniscal tissue in the knee.

A September 2009 report recommended a scientific re-evaluation of the device because the administrative record did not supply a basis for the FDA’s December 2008 decision that was adequate to dispel questions about the role of outside pressures on the review process. This re-evaluation, begun in the fall of 2009, included a team of scientists at the agency who were not involved in previous reviews of the device. Another advisory committee meeting was also held in March 2010.

The FDA has now concluded that the Menaflex device is intended to be used for different purposes and is technologically dissimilar from devices already on the market, called “predicate devices.” These differences can affect the safety and effectiveness of the Menaflex device. For example, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace tissue that was surgically removed. Because of these differences, the Menaflex device should not have been cleared for approval, FDA concluded.

FDA officials stated that it is unlikely that explanting the device will generally be appropriate or necessary because the device is replaced with new tissue. However, patients who have had the Menaflex device implanted are being encouraged talk with their surgeon or other healthcare professional about what, if any, steps should be taken.

Botox® Approved to Treat Chronic Migraine

Botox injection (onabotulinumtoxinA) was approved by FDA last month to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the week.

To treat chronic migraines, Botox, manufactured by Allergan, Inc, is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headache. It is important that patients discuss with their physician whether Botox is appropriate for them.

The most common adverse reactions reported by patients being treated for chronic migraine were neck pain and headache. Botox has a boxed warning that says the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. There has not been a confirmed serious case of spread of toxin effect when Botox has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when Botox Cosmetic has been used at the recommended dose to improve frown lines.

Program Helps NIH Researchers Skip Traditional Post-Doc Training

NIH intends to invest approximately $60 million over the next five years in the NIH Director’s Early Independence Award (EIA) program to help junior investigators leapfrog over traditional post-doctoral training and move into independent academic positions at US institutions, directly upon completion of their graduate research degrees.

Recent trends have demonstrated an increase in the length of the traditional scientific training period that often translates into an increase in the amount of time it takes for scientists to embark on independent research careers, NIH officials stated. These hurdles can result in valuable time lost by scientists in pursuit of independent biomedical research and deter students as they consider possible careers in biomedical research.

Although traditional post-doctoral training is appropriate for the majority of new PhD and MD recipients, NIH believes there is a pool of junior scientists who have the intellect, scientific creativity, drive, and maturity to flourish independently without the need for traditional post-doctoral training. NIH has created the EIA program to provide support for outstanding investigators within a year of completion of their degree to launch their own independent research programs.

NIH expects to issue up to 10 awards in the fall of 2011. To apply for these awards, exceptional junior investigators must identify a host institution. Alternatively, institutions may actively recruit exceptional junior scientists to apply for these positions. These awards will be very selective, and each institution may only submit two applications. EIA recipients will receive up to $250,000 in direct costs per year for up to five years for research that complements and enhances an institution’s research program.

The deadline for submitting Early Independence Award applications is January 21, 2011. Additional information, including the funding opportunity announcement is available at: http://commonfund.nih.gov/earlyindependence.

SPRINT Study Expanded to Include More Older Adults

NIH plans to add 1,750 participants over the age of 75 to its upcoming Systolic Blood Pressure Intervention Trial (SPRINT) to determine whether a lower blood pressure range in older adults will reduce cardiovascular and kidney diseases, age-related cognitive decline, and dementia.

“No large-scale clinical trial has examined the impact of aggressively lowering systolic blood pressure among older adults,” said Susan B Shurin, MD, acting director of the National Heart, Lung, and Blood Institute. The American Recovery and Reinvestment Act will fund the first two years of the study expansion — called SPRINT-Senior — for $12.7 million. The NIH is providing $30.1 million for the remaining six years of the project.

Current clinical guidelines recommend maintaining a systolic blood pressure of less than 140 for healthy adults of all ages and 130 for adults with kidney disease or diabetes. Two previous trials found that reducing systolic blood pressure in older participants reduced stroke, heart failure, and overall cardiovascular events by more than 30%. SPRINT will evaluate the safety and potential benefits or risks of maintaining systolic blood pressure at either less than 140 (standard group) or less than 120 mm Hg (treatment group)—a lower target than currently recommended or studied in previous trials.

Announced in 2009, SPRINT is a nine-year study to be conducted in over 70 clinical sites across the United States. Including the 1,750 new SPRINT-Senior participants, approximately 9,250 people age 55 years or older are expected to be enrolled. Researchers will treat study participants with commonly available medications to achieve their target blood pressure. Those in the treatment group will take an average of three to four medications. Those in the standard group will take an average of two medications. The study will include standard tests for determining the health of the heart, kidneys, and brain.

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