The title seems to speak enough for itself. This thing could also be used orally or underarm.
More on the craze at Cartoon Brew...
Product page: Musical SpongeBob™ Digital Thermometer ...
The title seems to speak enough for itself. This thing could also be used orally or underarm.
More on the craze at Cartoon Brew...
Product page: Musical SpongeBob™ Digital Thermometer ...
Nomir Medical Technologies of Waltham, Mass. is reporting that it plans to initiate a study of its Noveon® direct optical energy device. The company believes that its light-based system can target for elimination a number of bacterial and fungal infections, while also "promoting healthy tissue recovery." The first target on the company's list is everyone's favorite onychomycosis (toenail fungus). The representative for the company tells Medgadget that the device "utilizes two discrete near-infrared wavelengths at low power-- it is photobiologic in nature and doesn’t use heat. Nomir is also developing products based off of its optical energy platform for MRSA, periodontal disease, and diabetic foot ulcers (wound care) in addition to OM (onychomycosis)."
From the press release:
The primary objective of the trial is to test the efficacy and safety of Noveon in treating patients with onychomycosis (toenail fungus). The target population for this study is patients with toenail onychomycosis, as confirmed by culture, with the goal of gaining a new FDA approval to use the device for the treatment of onychomycosis.“This pivotal trial initiation is a major step for Nomir, moving us closer to commercial launch of our first product utilizing our proprietary dual-wavelength optical energy technology,” stated Richard Burtt, CEO of Nomir Medical Technologies. “Noveon represents a novel treatment approach of using optical energy to address disease indications, such as onychomycosis, that are typically sub-optimally treated with traditional pharmaceutical drugs. In pilot studies, Noveon demonstrated 87% clinical improvements, and we are therefore hopeful for similarly positive outcomes from this investigation.”
In November 2007, Nomir received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to utilize Noveon during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry, and otolaryngology. Nomir’s regulatory strategy accelerates the review process for the FDA by de-coupling the device clearance from the application clearance.
Forty evaluable subjects will be enrolled in the prospective, randomized, multi-site U.S. trial. It is expected that this will provide at least 30 evaluable subjects, two-thirds of which will be treated with Noveon and the remaining serving as controls. Study objectives include assessing clinical improvement and mycological decontamination of the treated area of the nail. Patients will receive four treatments over a four-month period and will be followed up to one year following the initial treatment to assess clinical improvement and mycological response.
Some have questioned if CAM-trained doctors are able to practice as primary care physicians and if we can trust their judgments. The concern that probably most comes to mind is whether these doctors are being taught the scientific process and how to recognize sound evidence from modalities that negate all known laws of science and biological plausibility.
Pretty remarble uh? Dr Katz goes through several different trials, all of which come out negative. And what is his conclusion? You guessed.His conclusion is not that the treatments don’t work but that we need a “more fluid concept of evidence”.
It’s equally bizarre to hear Richard Belitsky, Dean of Medical Education at Yale saying he is “very proud” of this betrayal of enlightenment values. If this is what Yale now considers to be education, it might be better to go somewhere else.
Flexner would have thought it quite inconceivable that in 2007 medical schools would be offering Continuing Medical Education in homeopathy.
Very few university administrators have the intellectual integrity to turn down money, whatever the level of dishonesty that is required by its acceptance. You can buy a lot of silence for $100m…
Covidien has announced that its innovative AbsorbaTack™ 5mm absorbable mesh fixation device for hernia repair will now be distributed in Europe. The device, designed for a variety of hernia repairs, including laparoscopic ventral hernia as well as a laparoscopic inguinal repair, has already been OK'ed for marketing by the FDA, and the device was introduced to the US market back in January 2008.
More about the AbsorbaTack:
The AbsorbaTack(TM) 5mm absorbable tacks provide strong mesh attachment to the surrounding tissues, while reducing the amount of foreign material remaining in the patient long-term. Coupling the absorbable fixation of the AbsorbaTack(TM) with Covidien's Parietex(TM) mesh, a hydrophilic polyester mesh that establishes fast intimate tissue integration, offers an appropriate clinical solution. These leading innovative products were designed in collaboration with surgeons, keeping patient comfort in mind.
To help you understand how the device works, the company is distributing the following product brochure:
Product page: AbsorbaTack 5mm Absorbable Fixation Device...
Press release: Covidien Introduces AbsorbaTack(TM) 5mm Hernia Fixation Device Featuring Absorbable Tacks in Europe...
Oscar Pistorius is entering history, and making Medgadget editors very happy, as the double leg amputee won an appeal to participate in the Beijing Olympics and run against properly legged runners. This was surprising news following last January's decision by the International Association of Athletics Federations to not let Pistorious run.
More from Times Online...
Press release by Rice University: Study revives Olympic prospects for amputee sprinter...
(hat tip: Matt Drudge)
Kristin O'Friel, a student at the NYU art school, has designed this corset to help you stop breathing as the CO2 levels in the environment go up. It is not clear to us whether this was meant as a medical device, an artistic statement, a pulmonary fibrosis simulator, or a fashionable euthanasia machine for the environmentally conscious.
From the artist's site:
I am interested in making wearables that enable you to feel information your senses are not acutely aware of. The CO2 Corset monitors carbon dioxide levels in the environment and provides physical feedback by tightening the bodice in relation to air quality.Traditionally the corset is a rigid garment comprised of vertical boning that is worn under clothing for aesthetic or medical purposes. The article supports the torso and slims the figure by cinching the waist imposing a shallowness of breathe on the user, making it contextually appropriate as the wearable interface to air quality.
(hat tip: DVICE)
As any medical student knows, bacterial pili play a pretty important role in the pathogenesis of bacterial species. Understanding how the pili are formed might open a whole range of clinical strategies to combat the infectious nature in a variety of bacterial species.
Brookhaven National Laboratory reports about the latest research coming out of the lab:
Using two sophisticated imaging techniques, scientists at the U.S. Department of Energy's Brookhaven National Laboratory and collaborators at Stony Brook University, University College London, and Washington University School of Medicine have captured molecular-level "snapshots" of the cellular machinery that assembles hairlike projections on certain bacterial cells. These projections, called pili, enable the bacteria to attach to and infect bladder and kidney cells.In a paper appearing in the May 16, 2008, issue of the journal Cell, the team describes how their newly revealed structures provide a mechanistic understanding of the pilus assembly process - which could lead to new ways to thwart or treat urinary tract infections.
The research focuses on the surface pilus of E. coli bacteria, which cause urinary tract infections in 1 in 10 women in the U.S. every year. E. coli normally reside in the human gut, where they are harmless. But if the microbes get into the urinary tract, they produce sticky tendrils known as pili. These pili allow the bacteria to recognize, stick to, and invade cells lining the bladder and kidneys, and go on to cause infections.
"Understanding how the bacteria assemble these pili is a first step toward finding an antimicrobial inhibitor that interferes with the process," said Brookhaven biophysicist and study co-author Huilin Li...
A protein known as usher, which traverses the cell membrane, is the engine of the pilus assembly line. The usher catalyzes the assembly of individual components into a pilus and provides a pathway for the assembled pilus to move out of the cell and extend from the cell surface. The Cell paper describes a new high-resolution image of the translocation domain of the usher protein, as well as a broader view of the assembly apparatus caught in action with the pilus tip making its way out of the cell.
The usher protein structure was determined by Han Remaut, University College London, using x-ray crystallography at the European Synchrotron Radiation Facility in Grenoble, France, under the guidance of Gabriel Waksman, University College London, and Scott Hultgren, Washington University, St. Louis. In this technique, scientists analyze how a beam of x-rays bounces off or is scattered by a molecule to determine the relative positions of its individual atoms.
The images revealed a protein "dimer" made of two identical ushers, each forming a barrel-shaped pore with a "plug" blocking the opening of the barrel. The plug is suspected to move away, making space for the pilus to move through the membrane as it is formed.
The structure of a partially formed pilus in association with the usher dimer was determined by single-particle cryo-electron microscopy (cryo-EM) by postdoctoral researchers Chunyan Tang and Tao Wang working with Li at Brookhaven Lab. The structure of this complex, which had been isolated by microbiologist David Thanassi and colleagues at Stony Brook University, confirmed the dimeric form of the functional usher protein, supporting the crystallography result as well as previous research on the structure by Li's group.
Interestingly, says Li, the pilus tip fiber appears to grow from only one of the two usher pores. However, both ushers are involved in recruiting and incorporating the pilus components into the growing pilus.
"Both techniques were essential to gaining insights into the pilus formation process," said Li. "Crystallography is good at revealing very high resolution structures of relatively small proteins or individual proteins, but not so good at imaging multiple protein assemblies. In contrast, cryo-EM is good at revealing the structure of large protein assemblies, but at lower resolution. When combined, the high-resolution structures of individual pieces (or component proteins) from crystallography can be placed into the cryo-EM map of the whole assembly, yielding a comprehensive understanding of the underlying biology," he explained.
Full story: Molecular 'Snapshots' Capture Infectious Pili Formation...
Michael Berger over at Nanowerk has filed a report about a novel nanoscale sensor platform developed by investigators at the Institute of Physical Chemistry, University of Mainz in Germany. The most exciting thing for us about the platform, which is built upon membrane coated plasmonic particles, is in its ability to offer a local analysis of protein interaction with biological membranes, or as explained in the article, these nanoparticles "can serve as reporters for cellular reactions taking place on and within biological membranes."
Read: Probing biomolecular interactions with single plasmonic nanoparticles...
Abstract: Protein--Membrane Interaction Probed by Single Plasmonic Nanoparticles ASAP Nano Lett., ASAP Article, 10.1021/nl080805l
Here's an interesting idea. The Netherlands Organization for Scientific Research (NWO) is reporting that a Dutch investigator Tim Idzenga believes that a microphone attached to perineum in men can listen to changes in the sound of flowing urine during urination, potentially detecting hissing tones of benign prostatic hyperplasia. He even wants to commercialize the idea to develop a diagnostic system:
Elder men with voiding symptoms, such as a weak urinary stream and frequent voiding, often suffer from an enlarged prostate, clinically known as 'Benign Prostatic Enlargement' (BPE). However, a weak urinary stream and frequent voiding can also be caused by a weak bladder, for which a prostate operation does not help.If BPE is suspected in a patient, the bladder pressure during voiding is measured using a catheter inserted into the bladder via the urethra. The urinary flow is simultaneously recorded. This investigation is time-consuming, painful and carries a risk of infection. On top of this, it is not carried out in all patients with BPE symptoms. Consequently, there is a need for a simple, painless measurement method for determining the resistance of the urethra and its location.
Tim Idzenga came up with the idea of using the sound produced by the urinary flow in the urethra as a measure of the urethral resistance. He performed the measurement by placing a microphone against the perineum, between the scrotum and anus. The frequency spectrum of the sound was found to correlate with the narrowing of the urethra. The degree of narrowing can therefore be determined from the recorded urinary sound.
A patent for this invention is being applied for in cooperation with the company IQ+ Medical BV. The method will be tested at the urology outpatient clinic of the Erasmus MC in Rotterdam. Besides the standard method, patients with voiding symptoms will also be asked to urinate with a microphone against the perineum.
NWO press release: Listening to the urinary stream...
Image credit: Wellcome images: Anatomy of the prostate. Colour artwork....
(hat tip: MTB Europe)
Once again a study challenges dogma - POISE Published, Debate on Perioperative Beta Blockers Continues
Publication of the landmark Perioperative Ischemic Evaluation (POISE) trial online May 12, 2008, in the Lancet has triggered another heated debate about the pros and cons of using beta blockers perioperatively in noncardiac surgery [1]. In one corner are the authors of POISE, which was first reported at the American Heart Association (AHA) 2007 Scientific Session and which found that beta blockers do more harm than good in this setting; and in the other, two accompanying editorialists, who suggest that it is the POISE protocol—specifically, the doses of beta blocker used and timing of initiation of therapy—that explains the findings and that a different protocol might shift the risk/balance back in favor of using beta blockers in this setting [2].
"What POISE says is that in the dosing we used, we see beta blockers have substantial risk in the perioperative setting," Dr Philip J Devereaux (McMaster University, Hamilton, ON) told heartwire. "And until someone demonstrates with a clear and large randomized controlled trial that an alternative dose is both effective and safe, it’s just not rational, not in people’s best interests, to be assuming—that’s how we got into this trouble in the first place."
I have not done preoperative and perioperative management for many years, and have not followed this literature carefully. I did know that most experts thought that beta blockers markedly decreased MI risk during and after non-cardiac surgery. So as a more casual observer, this article surprised me.
Devereaux first reported POISE—a randomized controlled trial in more than 8000 patients undergoing noncardiac surgery who were not on beta blockers, randomized to either the beta blocker metoprolol or placebo—at the AHA meeting last year. The results showed that the beta blocker reduced the risk of myocardial infarction (MI) but increased the risk of severe stroke and overall death in patients undergoing noncardiac surgery. It suggested that for every 1000 patients treated, metoprolol would prevent 15 MIs, but there would be an excess of eight deaths and five severe disabling strokes.
Devereaux told heartwire that the new analysis featured in the Lancet "helps to explain why death went up and stroke went up [with metoprolol]. Death was clearly driven by a hypotensive state, leading to shock, which we’ve recognized is so common in the perioperative setting, and that’s what tipped the balance and why we saw the excess death. Also it’s not that simple to predict who will develop shock, and many people who are going to get it are the same people who are going to get a heart attack also."
He and his coinvestigators conclude: "Patients are unlikely to accept the risk associated with perioperative extended-release metoprolol. Current perioperative guidelines that recommend beta-blocker therapy to patients undergoing noncardiac surgery should reconsider their recommendations in light of these findings."
I take several messages from this study. First, we really do not know answers to complex clinical questions until we careful prospective studies, especially randomized controlled clinical trials. Second, the performance indicator and safety movement which has a "ready, fire, aim" philosophy, must reevaluate their strategies. One must wonder if our current push towards performance measurement has caused strokes and death in some patients. Finally, 30 years after finishing my residency, I continue to reshape my medical knowledge. As new knowledge appears we must quickly adjust our practice. I am interested in the ability of the performance movement to adjust. Of course, they will shrug off the unintended consequences that they caused here.
Leica Microsystems has introduced two new stereomicroscopes, Leica M205 FA (top) and M165 FC (below). The devices are based on the company's innovative FusionOptic™ technology that utilizes normal human neurology to increase the resolution of stereomicroscopes (for details, see our Nov. 2007 post:FusionOptic™ technology).
German Healthcare Export Group provides the details:
The Leica M205 FA and M165 FC stereomicroscopes are Leica Microsystems‘ latest addition to its innovative M series for demanding fluorescence applications in developmental, molecular and cellular biology.
Combining the revolutionary FusionOptics™ technology with the successful TripleBeam™ principle, the fully automated Leica M205 FA creates fluorescence images of exceptional quality. Used for the first time in the M series, FusionOptics™ (patent pending) takes advantage of a neurological phenomenon: The left beam path produces great depth of field, while the right beam path provides a high-resolution image.
The human brain itself then combines the best information from both channels, using it to compose an image whose resolution and depth of field have never been achieved in any stereomicroscope before.
With its fully apochromatic optics, the largest zoom range on the market (20.5:1) and the top resolution performance of up to 1050 lp/mm, the Leica M205 FA is able to show the viewer details that used to be invisible.
The TripleBeam™ principle, with its patented third beam path reserved exclusively for fluorescence illumination, delivers evenly illuminated, reflex-free fields of view at all zoom settings. Besides this, the FluoCombi III™ objective revolver features the unique capability to exploit all the advantages of both stereo and high-resolution micro-objectives on one instrument with a simple switch. It enables parallaxfree imaging from overview magnification to the finest detail. Time-intensive studies of living organisms and documentation of complex images series and multifluorescence images are made possible and instantly reproducible by motorizing focus, zoom, filter changer, iris diaphragm fluorescence intensity manager and microscope stage.
An external SmartTouchTM control unit ensures convenient control of all microscope functions using a clearly arranged touch display and freely programmable control buttons. The microscope is fully integrated in the modular software solutions Leica AF6000 E to AF6000. For documentation, image overlay and time series, the Leica AF6000 E is recommended as an introductory software package. This can be upgraded to the Leica AF6000 as necessary to suit applications ranging from multi-channel fluorescence, time and z series with parallax correction to 3D reconstruction.
The Leica M165 FC continues the tradition of high-quality manual fluorescence stereomicroscopes. With this microscope, the classical stereo-optics approach has been exploited to the utmost optical limits. The fully apochromatically corrected 16.5:1 zoom – combined with TripleBeam™ and FluoCombi III™ – guarantees high-contrast fluorescence images down to the finest structures of the specimen. Encoded zoom, iris diaphragm and objective revolver allow configuration parameters and optical data to be reproducibly read out at the computer.
Product pages: Leica M205 FA and Leica M165 FC
German Healthcare Export Group: Leica Microsystems Combines FusionOpticsTM with TripleBeamTM...
For this one, your glasses ain't gonna be much help. The National Institute of Standards and Technology (NIST) will be hosting for the second time the world's most puny sport, and you are invited. This year, three student teams (Carnegie-Mellon University, the U.S. Naval Academy, and the University of Waterloo, from Ontario, Canada), will participate in a public exhibition at the 2008 US RoboCup Open in Pittsburgh, PA, May 25 to 27, a competition "where miniature "soccer players"--computer-driven robots six times smaller than an amoeba operating on a field the size of a grain of rice--will show off their skills." So, what does it have to do with medicine? Consider the following:
The nanobots will be demonstrating agility, maneuverability, response to computer control and ability to move objects—all tools that future miniaturized mechanized workers will need for tasks such as microsurgery within the human body or the manufacturing of atom-sized components for microscopic electronic devices.RoboCup is an annual international competition designed to foster innovations and advances in artificial intelligence and intelligent robotics by using the game of soccer as a testing ground. NIST’s goal in coordinating competitions between the world’s smallest robots is to show the feasibility and accessibility of technologies for fabricating MicroElectroMechanical Systems (MEMS), tiny mechanical devices built onto semiconductor chips and measured in micrometers (millionth of a meter).
The soccer nanobots are operated by remote control under an optical microscope. They move in response to changing magnetic fields or electrical signals transmitted across the microchip arena. Although the bots are a few tens of micrometers to a few hundred micrometers long, they are considered “nanoscale” because their masses range from a few nanograms to a few hundred nanograms. They are manufactured from materials such as aluminum, nickel, gold, silicon and chromium.
Among the nanosoccer drills that will be demonstrated in Pittsburgh are the two-millimeter dash in which nanobots seek fast times for a goal-to-goal sprint across the playing field; a slalom course where the path between goals is blocked by “defenders” (polymer posts); and a ball handling exercise that requires robots to move “nanoballs” (spheres with the diameter of a human hair) into the goal. One team even plans to conduct its runs underwater to lessen friction.
RoboCup and NIST are jointly organizing the upcoming U.S. Open nanosoccer demonstration as the final step toward the first official Nanogram League competition for soccer nanobots at the 2009 international RoboCup event in Austria.
Full story: Public Invited to See Nanosoccer Robots in Action in Pittsburgh...
The FDA has given approval to Advanced Medical Optics to market the company's new iFS™ Advanced Femtosecond Laser system, a 5th generation device, for IntraLASIK procedures.
Features of the device from the press release:
Capable of creating a corneal flap during the LASIK procedure in less than 10 seconds, the iFS(TM) Advanced Femtosecond Laser's unique inverted bevel-in side cut angle is designed to provide a virtually effortless flap lift, increase post-operative flap adhesion and enhance the biomechanical stability of the post-LASIK cornea. With full customization capabilities, it also produces an elliptical flap to enhance surgical options and includes IntraLase-Enabled Keratoplasty (IEK).Additional features of the 5th generation IntraLase femtosecond technology include:
Higher repetition rate Tighter spot separation; lower energy High-resolution digital video microscope New contemporary user interface, keyboard and touch screen Ergonomic design for maximum surgeon comfort
Press release: Advanced Medical Optics Receives FDA Clearance For iFS(TM) Advanced Femtosecond Laser ...
MedPage Today
Dr. Rubin and colleagues calculated standard incidence ratios (SIRs) of observed to expected cases of invasive colorectal cancer for each urologic cancer site and vice versa.
The analysis showed:
* Patients with previous ureteral cancer had an 80% increase in the risk of subsequent colorectal cancer, with an incidence ratio of 1.80 and a 95% confidence interval from 1.46 to 2.20.
* Those with renal pelvis cancer had a 44% increase in the risk of colorectal disease, with an incidence ratio of 1.44 and a 95% confidence interval from 1.20 to 1.72.
* Patients with bladder or renal parenchymal cancer had small but statistically significant increases in the risk of subsequent colorectal cancer, but the researchers concluded the increases were probably not clinically significant.
* The risk for any urologic cancer was increased after a diagnosis of colorectal cancer, with an incidence ratio of 1.24 and a 95% confidence interval from 1.20 to 1.28.
This study showed an increase risk of colon cancer after urinary tract cancers.
The surgical margins were similar between the two groups. No significant difference was found in the postoperative urinary bother score or the interval to social or perfect continence between the two groups.
The results of this study have shown that the presence of a median lobe does not alter the outcomes in patients who undergo robot-assisted prostatectomy.
The median lobe can be a scary finding for the novice robotic surgeon. My team at NBI has developed several techniques to handle median lobes while preserving as much bladder as possible.
I have put a video from about 18 months ago on google video showing one of our techniques:
I have changed by preoperative management to include a cystoscopy about 1 year ago on all patients to assess for prostate shape. I can now predict these in all patients.
I am a little surprised that these patients did not have differences except more needed bladder neck repairs. I think these patients are more likely to have bladder symptoms since most have obstruction and over active bladders to start with. In my series, they usually get their catheters out in 5 days instead of 3, and I warn them of expecting more urinary problems in the short term than others.
From MedWire News
Among prostatectomy patients, those with diets high in high saturated fat (HSF) are almost twice as likely to experience biochemical failure as those who consume a low saturated fat (LSF) diet, say US scientists.
Several studies have indicated that obesity is associated with an increased risk of biochemical failure after treatment with radical prostatectomy or external beam radiation for localized prostate cancer.
Patients at risk of prostate cancer and thos with prostate cancer should reduce their fat intake.
Argonne Laboratory researchers have developed a method to align molecules using lasers, which may eliminate the need to crystallize large groups of molecules for synchrotron X-ray diffraction.
Crystallization allows scientists to create a periodic structure that will strongly diffract in specific directions when bombarded with X-rays. From the resulting diffraction pattern, scientists can construct a real-space image of the crystal. However, without crystallization, when X-rays collide with multiple, randomly oriented molecules, they diffract in different directions, making it impossible to create a composite diffraction image, said Argonne Physicist Robin Santra.Some molecules, such as many involved with drug interaction, cannot be crystallized, and imaging would require numerous samples to bombard in order to get a full composite picture. Young's laser technique allows for millions of molecules suspended in a gaseous state to be aligned so that, when bombarded with X-rays, they all diffract in the same way. The resulting images are at atomic level resolution and do not require crystallization.
"Understanding the structure of the approximately 1 million human proteins that cannot be crystallized is perhaps the most important challenge facing structural biology," Young said. "A method for structure determination at atomic resolution without the need to crystallize would be revolutionary."
Young and her team have successfully aligned molecules using a laser, probed the aligned ensemble with X-rays and shown theoretically that the technique could be used for X-ray imaging - see E. R. Peterson et al., Applied Physics Letters 92, 094106 (2008) - but they require a proposed upgrade to the Advanced Photon Source facility located at Argonne before X-ray diffraction can be done experimentally.
Press release: Argonne scientists use lasers to align molecules ...
St. Jude Medical is giddy with excitement about the results of four studies presented at Heart Rhythm Society's 29th Annual Scientific Sessions in San Francisco this week. The multicenter studies have shown that the company's Riata ST Optim leads, designed for implantable cardioverter defibrillators (ICD) or cardiac resynchronization therapy (CRT-D) devices, perform extremely well in clinical settings. The company describes these leads as "highly advanced tachycardia pacing leads, with an overlay of St. Jude Medical's innovative Optim insulation and a design intended to ease implant, and promote reliability."
The studies analyzed the experience of 7,498 patients who were implanted with Riata leads as part of their implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) systems. All sites participating in the four studies (ACT, OPTIMUM, RHYTHM and PAS; see below for a description of the studies) were monitored. To ensure the data were as accurate as possible, each patient's source records were individually reviewed to be certain that all lead-related complications (further sub-categorized as fracture, insulation damage, perforation or dislodgment) were reported.The data showed that adverse event rates for all categories of lead-related complications were very low. Overall, the Riata leads' fracture rates were 0.09 percent (9 in 10,000), insulation damage rates were 0.13 percent (13 in 10,000, with no insulation failures exhibited in Riata leads utilizing Optim(R) insulation), perforation rates were 0.31 percent (31 in 10,000), and dislodgement rates were 0.88 percent (88 in 10,000). These adverse events rates are significantly lower than many previously reported rates in the medical literature on ICD leads.
The results are believed to be the largest and broadest analysis of lead-related complications ever to be presented, especially with complete data monitoring, and unlike reports of single-center experiences or case reports, should best represent real-world experience in a wide range of implanter's hands.
The results from these studies are particularly significant given the duration of follow-up, which was a median of 22 months for the four studies.
Press release: Results from Studies Evaluating High-Voltage Lead Performance Presented at Heart Rhythm Society's 29th Annual Scientific Sessions ...
Product page: Riata® ST OptimTM Defibrillation Lead ...
Scientists from UC San Diego, UC Santa Barbara, and MIT developed metal nanoparticles, that can, because of their shape and polymer coating, evade the body's immune system, allowing for free movement around the body. Additionally, a coating of a special peptide F3 molecule allows the nanoparticle to hone in on tumor cells. Perhaps this is the complimentary technology that is required to make the Kanzius Machine effective against tumors?
The scientists constructed their nanoworms from spherical iron oxide nanoparticles that join together, like segments of an earthworm, to produce tiny gummy worm-like structures about 30 nanometers long—or about 3 million times smaller than an earthworm. Their iron-oxide composition allows the nanoworms to show up brightly in diagnostic devices, specifically the MRI, or magnetic resonance imaging, machines that are used to find tumors.“The iron oxide used in the nanoworms has a property of superparamagnetism, which makes them show up very brightly in MRI,” said Sailor [Michael Sailor, a professor of chemistry and biochemistry at UC San Diego who headed the research team --ed.]. “The magnetism of the individual iron oxide segments, typically eight per nanoworm, combine to provide a much larger signal than can be observed if the segments are separated. This translates to a better ability to see smaller tumors, hopefully enabling physicians to make their diagnosis of cancer at earlier stages of development.”
In addition to the polymer coating, which is derived from the biopolymer dextran, the scientists coated their nanoworms with a tumor-specific targeting molecule, a peptide called F3, developed in the laboratory of Erkki Ruoslahti, a cell biologist and professor at the Burnham Institute for Medical Research at UC Santa Barbara. This peptide allows the nanoworms to target and home in on tumors.
“Because of its elongated shape, the nanoworm can carry many F3 molecules that can simultaneously bind to the tumor surface,” said Sailor. “And this cooperative effect significantly improves the ability of the nanoworm to attach to a tumor.”
The scientists were able to verify in their experiments that their nanoworms homed in on tumor sites by injecting them into the bloodstream of mice with tumors and following the aggregation of the nanoworms on the tumors. They found that the nanoworms, unlike the spherical nanoparticles of similar size that were shuttled out of the blood by the immune system, remained in the bloodstream for hours.
“This is an important property because the longer these nanoworms can stay in the bloodstream, the more chances they have to hit their targets, the tumors,” said Ji-Ho Park, a UC San Diego graduate student in materials science and engineering working in Sailor’s laboratory.
Press release: UC San Diego Researchers Target Tumors with Tiny 'Nanoworms' ...
Regular readers know that I consider making the proper diagnosis the epitome of internal medicine (as well as many other specialties.) We know that we often miss diagnoses, but we often do not know why. I have often recommended Jerome Groopman’s book - How Doctors’ Think - as a primer on medical cognition. Currently he has a regular column in the ACP Internist. The current article gives a classic example of medical diagnostic error - Beware of ‘search satisfaction,’ a common cognitive error .
Dr. Ginsberg told us that he viewed this case as “a horse masquerading as a zebra.” Why didn’t we see the horse? To help answer the question, Dr. Ginsberg sent us this picture of how the mind may not perceive a visual abnormality.
If you see nothing wrong, try again. It took us several tries.
The current American Journal of Medicine has an interesting article on diagnostic error - Overconfidence as a Cause of Diagnostic Error in Medicine. This article is long and detailed. I recommend it only for those who want to study this problem in depth.
Tradeoffs in Time, Cost, and Accuracy
As clinicians improve their diagnostic competency from beginning level skills to expert status, reliability and accuracy improve with decreased cost and effort. However, using the strategies discussed earlier to move nonexperts into the realm of experts will involve some expense. In any given case, we can improve diagnostic accuracy but with increased cost, time, or effort.
Several of the interventions entail direct costs. For instance, expenditures may be in the form of payment for consultation or purchasing diagnostic decision-support systems. Less tangible costs relate to clinician time. Attending training programs involves time, effort, and money. Even strategies that do not have direct expenses may still be costly in terms of physician time. Most medical decision making takes place in the “adaptive subconscious.” The application of expert knowledge, pattern and script recognition, and heuristic synthesis takes place essentially instantaneously for the vast majority of medical problems. The process is effortless. If we now ask physicians to reflect on how they arrived at a diagnosis, the extra time and effort required may be just enough to discourage this undertaking.
Applying conscious review of subconscious processing hopefully uncovers at least some of the hidden biases that affect subconscious decisions. The hope is that these events outnumber the new errors that may evolve as we second-guess ourselves. However, it is not clear that conscious articulation of the reasoning process is an accurate picture of what really occurs in expert decision making. As discussed above, even reviewing the suggestions from a decision-support system (which would facilitate reflection) is perceived as taking too long, even though the information is viewed as useful.173 Although these arguments may not be persuasive to the individual patient,2 it is clear that the time involved is a barrier to physician use of decision aids. Thus, in deciding to use methods to increase reflection, decisions must be made as to: (1) whether the marginal improvements in accuracy are worth the time and effort and, given the extra time involved, (2) how to ensure that clinicians will routinely make the effort.
How important is diagnostic accuracy? I would argue that if we could measure accuracy we would have the best single measure of physician quality. However, we are forever challenged with developing a measure, because we have difficulty knowing the correct answer - that in fact is the problem.
Clearly, we should encourage physicians to take the time to think about diagnosis. Perhaps, we could actually help patients through the act of spending money on cognition. Perhaps, but then who would pay for me to think?
Google Spreadsheets added an option in the sharing dialog that allows anyone to view or edit the spreadsheet just by knowing the URL.
Becoming a better ward attending: Ten modifiable behaviors
This exploration is published in ACP Hospitalist. We (db and Lisa Willett) developed the paper as part of a faculty development program conducted at the Southern Society of General Internal Medicine. We are now using this framework for short (1-1.5 hour) teaching workshops.
For those who teach and learn, we would love your comments.
From Medscape
May 12, 2008 -- The urine test for the PCA3 gene, already marketed for use in diagnosing prostate cancer, could also be useful in prognostication. It might have clinical application in selecting men with low-grade and low-volume tumors who would be suitable candidates for active surveillance, say researchers writing in the May issue of the Journal of Urology.
The PCA3 urine test, marketed in Europe by Gen-Probe, has been shown in previous studies to be more accurate in diagnosing early prostate cancer than serum levels of prostate-specific antigen (PSA).
I usually use the PCA 3 test for men who have had a negative biopsy and we are considering performing a second one. I usualy use it for men with high grade PIN after one biopsy. If the PCA 3 is positive, I usually perform a second biopsy. I have not looked at my data to see if the above correlation exists, but that would be interesting.
I also am not sure if you can use PCA 3 tests that are taken a few months apart to mean anything. For example, would a rise in PCA 3 be expected if a man develops cancer or the cancer is growing?
I have moved into cell phone technology. Through a site called Wirenode, I now have cell phone friendly access. I have an advertisement in the side bar, but here is the mobile phone web address - http://medrants.wirenode.mobi
Please let me know if this addition has value.
The Experience of Pay for Performance in English Family Practice: A Qualitative Study
PURPOSE We conducted an in-depth exploration of family physicians’ and nurses’ beliefs and concerns about changes to the family health care service as a result of the new pay-for-performance scheme in the United Kingdom (Quality and Outcomes Framework [QOF]).
METHODS Using a semistructured interview format, we interviewed 21 family doctors and 20 nurses in 22 nationally representative practices across England between February and August 2007.
RESULTS Participants believed the financial incentives had been sufficient to change behavior and to achieve targets. The findings suggest that it is not necessary to align targets to professional priorities and values to obtain behavior change, although doing so enhances enthusiasm and understanding. Participants agreed that the aims of the pay-for-performance scheme had been met in terms of improvements in disease-specific processes of patient care and physician income, as well as improved data capture. It also led to unintended effects, such as the emergence of a dual QOF-patient agenda within consultations, potential deskilling of doctors as a result of the enhanced role for nurses in managing long-term conditions, a decline in personal/relational continuity of care between doctors and patients, resentment by team members not benefiting financially from payments, and concerns about an ongoing culture of performance monitoring in the United Kingdom.
CONCLUSIONS The QOF scheme may have achieved its declared objectives of improving disease-specific processes of patient care through the achievement of clinical and organizational targets and increased physician income, but our findings suggest that it has changed the dynamic between doctors and nurses and the nature of the practitioner-patient consultation.
Those who champion P4P make an unfortunate assumption. They believe that you can push one button, and only impact the desired outcome. They are obsessed with measurement, and believe that measurement will improve health care. They are so dangerous.
I will state that those who champion P4P are mistaken in the most dangerous way. Unless we carefully study the impact of incentives we could cause more harm than good.
Bob Wachter talked about this eloquently in March - The Great Quality Debate: Berwick’s Plea for Action vs. Evidence-Based Medicine.
On the other hand, in our zeal to “do something,” vigorously promoting or mandating practices with weak evidence risks squandering scarce resources, diverts us from better strategies, and subjects the safety field to the whims of opinions and biases. Berwick worries that our EBM pushback gives intellectual ammo to the dark forces of status quo. This is a reasonable concern. But given the public interest in quality and patient safety, I worry more that the distance between “this seems like a good idea” to “let’s include it as part of a campaign” to “let’s make it a new Joint Commission standard” to “let’s make it a state law” is perilously short. Accordingly, we should require awfully strong evidence that we’re doing the correct thing as we traverse that path, particularly when practices are complex and expensive.
The Annals of Family Medicine article raises many legitimate questions about Great Britain’s P4P experiment. We should learn from their experience.
People are not comfortable with confusion and uncertain outcomes. They seek clarity and meaning. The need for clarity and meaning takes people on many and varied journeys throughout life. Compare and contrast the quest and pathways of Dean Moriarty and Sal Paradise (Jack Kerouac, “On the Road”, 1957) with those of Forrest Gump (Winston Groom, “Forrest Gump”, 1986). Or, consider the quests and pathways of Dr. Albert Schweitzer and Mother Teresa. Professor Michael Heller is a Roman Catholic priest, cosmologist, and philosopher who seeks meaning at the boundary of science, philosophy, and religion, especially where these boundaries are in juxtaposition. Professor Heller believes “science gives us knowledge, and religion gives us meaning. Both are prerequisites of the decent existence.” (Brenda Goodman, New York Times, March 13, 2008) Regardless of the differences in the quests and pathways through life, the need for meaning gives fuel to the restless spirit and accounts for human momentum even without certainty as to the destination or outcome.
From Washington Post.com
"This reaffirms what many other manuscripts have shown, if you go to an individual who has experience, who does this on a consistent basis, your outcomes will be better," said Dr. Ihor S. Sawczuk, chief of urologic oncology for the Cancer Center at Hackensack University Medical Center, in New Jersey. "If you go to someone who does 20 to 50 procedures a year, that's better than somebody who only does two to three a year."
The only study I am aware of does not sure a large difference between the open and minimally invasive prostate cancer surgeries.
I agree with Dr. Sawczuk, a friend and colleague, that more experienced surgeons are more likely to have better results. The surgeon is important, probably more so than the technique. I think the best way to analyze this would have been to set up a study looking at high volume robotic vs. lap vs. open surgeons andhaving a 3rd party analyze the results. I do not think this is something that would ever be done.
My feeling after performing many open prostate cancer surgeries, a few laparoscopic ones, and over 400 robotic ones is that robotics gives me the ability to perform more accurate surgery, and the difference is more pronounced with more difficult cases.
Being able to remove the catheter within 3 days routinely without needing X-Rays would be difficult for me to achieve with open or laparoscopic surgery.
When I think of abdominal pain evaluation, I think of Cope’s Early Diagnosis of the Acute Abdomen
What does one say about the 21st edition of an authoritative clinical text first published in 1921? This revised edition by the eminent surgeon William Silen clearly demonstrates the beauty of succinct medical writing and the durability of clinical pearls. The previous edition was published in 2000 and the march of technology has continued relentlessly, threatening to overwhelm even the most ardent medical student’s or resident’s desire to obtain a complete history and perform a rigorous physical examination on patients presenting with symptoms and signs consistent with an acute abdomen.
Abdominal pain in many ways represents the epitome of history, physical exam and diagnostic testing. Lisa Sanders writes about a challenging story of abdominal pain in an adolescent. As usual she writes the story beautifully, and as a reader I kept trying to solve the story.
Functional results with regard to erectile function and urinary continence after prostate sparing cystectomy are good. Oncological results have been promising, but need to be confirmed after longer followup and in larger trials.
For men in need of a bladder removal for bladder cancer, my practice has always consisted of removing the entire prostate as well. This is what I learned at Indiana and have continued to do in NJ. As far as I know, urologic oncologists in the USA all agree on this.
In Europe I have read several studies that have left the prostate capsule or most of the prostate in place. I think you will see a higher rate of pelvic recurrences and bladder cancer recurrence in the prostate, as well as new prostate cancers this way. I do agree that men will have less side effects in regards to erections and continence potentially.
I have been performing robotic cystectomies for about 3 years now and feel that I can perform a more careful operation around the erection nerves and urinary muscles. I hope to improve on our past results while still removing the entire prostate wih the bladder.
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You will need a high speed connection to view this talk. I gave this talk at UC Davis, and they kindly archived it.
Long time readers will not be surprised by my comments, but I hope this discussions brings many ideas into focus.
Guidelines - a skeptic’s viewpoint
A premed student writes:
We see a trend that people are starting to say NP’s and CRNA’s, particularly in rural settings, are helping control costs while providing general care and limited anesthesia. I also see a trend that a lot of MD’s ad MD anesthesiologists are ranting that these types of advanced practice nurses are ruining general/family care and cannot and never will have the necessary training do to such a role without having been through med school - though not so much ranting about crna’s so long as they practice under an anesthesiologist and not solo.
So then nursing profession pumps out "Doctorate of Nursing Practice" to fill the void of internal medicine physicians.. though this is not a PhD role for academic/research settings.. it is for clinical settings. The AMA flips out again claiming ‘Dr. Nurse’ will confuse patients and cause problems.
Do you think advanced practice nurses like crna, fnp, nnp, etc., are doing an adequate job for their scope of practice..? Calling in the md for exceptional or issues out of their scope?
What do you think of crnas practicing solo without an md.. this seems to be a ‘problem’ in rural areas.
There is no doubt there is a shortage of health care professionals.. even down to lpns..
Being a medical professor and MD, what do you think?
Activated Vitamin D Associated with Mortality Drop in Chronic Kidney Disease
For patients with moderate-to-severe chronic kidney disease and hyperparathyroidism, activated vitamin D appears to lower the risk of death over two years, an observational study found.
The 429 patients with stage 3 or 4 disease who took oral calcitriol had a 26% reduced risk of death (P=0.016) and a 20% reduced risk of death or long-term dialysis (P=0.038) compared with 989 patients who did not take oral calcitriol, Bryan Kestenbaum, M.D., of the University of Washington here, and colleagues reported online in the Journal of the American Society of Nephrology. The results will be published in the August print issue.
These data have great importance to generalists and nephrologists. These data support the hypothesis that the secondary hyperparathyroidism Is a major problem for these patients.
From UroToday
Surgical waiting time from initial urological consultation to operative intervention does not adversely affect the outcome of renal cell carcinoma within the time frames analyzed in this study, in which 94% of cases occurred within 3 months. Individual urologist judgment remains a critical factor in the appropriate and timely care of the patient with a suspicious renal mass.
Patients often ask how soon they have to have surgery when diagnosed with a likely cancer. This study shows that for kidney cancer it does not seem to make much of a diffference. The main problem with tihs study is that patients with larger tumors often get counselled to have surgery right away, whereas smaller ones are often given the option to wait a few months if the patient wants to.
