Sunday, May 29, 2016
Gastroenterologists and other physicians are virtually unanimous in appreciating the vital importance of colonoscopy screenings. In preparation for colonoscopies, we direct patients to drink a large volume of bowel-cleansing liquid, usually in one day. Past studies have shown that splitting this dose—drinking half the night before and half in the morning before the procedure—leads to better bowel cleansing compared with drinking the entire dose the night before. Yet barriers still remain to the acceptance of split dosing, including the perceived patient inconvenience of consuming two separate doses. My colleagues and I wanted to learn whether the split-dose preparation is more convenient for patients, and whether it would lead to finding more precancerous polyps. Split dosing is already recommended by the U.S. Multi-Society Task-Force on Colorectal Cancer, and our study provides additional support for its benefits by demonstrating that it decreases total bowel prep ingestion time, reduces the intensity and duration of bowel movements, and is associated with less sleep disruption. The results were clear to us in confirming the superior performance of the split dose, not only in overall bowel cleansing, but in detecting dangerous polyps. Our team, including Carol Burke, MD, found that endoscopists reported “excellent” or “good” cleansing in 95.6% of the split-dose group, a full 10 percentage points above the single-dose group, which achieved those ratings in only 85.5% of cases. The split-dose method also resulted in a higher overall rate of finding polyps and adenomas. However, the most dramatic difference was specifically seen in detecting another serious and potentially life-threatening condition—the presence of sessile serrated polyps (SSPs). In screening patients from both groups, the physicians found SSPs at a rate four times higher in the split-dose group than in the single-dose group (9.9% vs. 2.4%). We regard our results as additional evidence for practitioners to confidently adopt split dosing as a standard procedure. For patients who aren’t given this option, we recommend they ask their GI about it. The improved ability to detect SSPs is too significant a benefit to overlook in our continuing effort to eliminate colorectal cancer. Nicholas Horton, MD, is a PGY-2 resident in internal medicine at the Cleveland Clinic. He completed medical school at the Wright State University Boonshoft School of Medicine, in Dayton, Ohio. He plans to pursue a fellowship in gastroenterology, and has a particular academic interest in colorectal cancer prevention and inflammatory bowel disease. Dr. Horton presented data from this study, “Sessile Serrated Polyps Are Detected More Often With Split Versus Single Dose Low Volume Bowel Preparation: Results From a Prospective Trial,” at the 2016 Digestive Disease Week (abstract Su1663). The study received outside funding from Salix Pharmaceuticals.
Posted by Dr. Walid Y. Farah at 8:41 AM
Ninety seconds of education appeared to work wonders in getting heartburn patients to optimize their use of the proton pump inhibitor omeprazole, researchers reported here at the annual Digestive Disease Week conference. Patients who were given instruction in the medicine's use by their doctor had a mean 4-point drop in Gastroesophageal Reflux Disease Symptom Assessment Scale Mean Symptom Score after 6 weeks compared with just minor change among patients who were not given the educational talk (P<0.01), said Abhijeet Waghray, MD, of MetroHealth System/Case Western Reserve University in Cleveland. Similarly, significant declines in symptom frequency and symptom severity were seen among those patients who had the intervention, Waghray said at his poster presentation. And what was the intervention that produced these results? Patients were told they they had to take their medication 15 to 30 minutes before their first meal of the day in order for omeprazole to be effective. "It takes about 90 seconds to deliver the message and answer any questions," he told MedPage Today. In so-called OSCAR (Omeprazole Dosing and Symptom Control -- A Randomized Controlled Trial), 29 patients were given the quick educational lesson when they came to the office and complained that their treatment wasn't effective; 35 other patients were controls -- they where not provided with emphasis on how to take their medicine, but rather were essentially waitlisted to receive the talk a few weeks later. In the meantime, they were encouraged simply to keep taking omeprazole. Patients were eligible for the study if their experienced heartburn three or more times a week despite treatment with 20 mg omeprazole. They were observed for 2 weeks on the current regimen and then were randomized to received the pep talk on optimal dosing time or were left to continue their medication as they were taking it. Their dose was not changed, although people who were on different doses were not included in the study, Waghray said, to reduce the variables in conducting the research. Four weeks later their symptoms were analyzed. Those given the added instruction achieved an overall significant decrease in symptoms, reflected in reductions in both symptom severity and symptom frequency, Waghray said. After the 6-week trial, the patients who were not given instruction in the first round were provided the educational talk. Symptom assessment at 4 weeks showed reductions similar to those achieved in the first intervention group. About 40% of the patients in the study were men; about 37.5% were Caucasian and 48.4% were African. More than 40% of the patient population had attended college or were college graduates or had done post-graduate studies. Waghray said there were no statistically significant differences between the groups' demographics. "Proper education and proton pump inhibitor dosing should serve to reduce the burden of persistent GERD symptoms and related costs of uncontrolled disease," Waghray said. William Ravich, MD, of Johns Hopkins University, told MedPage Today, "It is absolutely true that people come in and are not taking their medication at the appropriate time. This has been the standard time for taking these drugs since they were introduced decades ago. Either doctors don't pay enough attention to educating the patient or the patient ignores it. "It is very difficult to take medication a half hour before breakfast," said Ravich, who was not involved with the study. "I have trouble taking medicine on any regular schedules. So I think this has to be reinforced, and I think this study justifies the original recommendations for taking the drugs."
Posted by Dr. Walid Y. Farah at 8:35 AM
Hospitals are taking the problem of gastrointestinal endoscope reprocessing seriously, reports here at Digestive Disease Week suggested, to the point of spending hundreds of thousands of dollars in order to meet recent FDA guidelines. Reports last year that dozens of patients had been sickened -- some fatally -- by multidrug-resistant infections they acquired from incompletely sterilized duodenoscopes and other endoscopy instruments have prompted an industry-wide effort to do a better job of cleaning the equipment after use. In August, after it was revealed that the manufacturers had received numerous reports of carbapenem-resistant enterobacterial (CRE) infections over a multiyear period without doing anything about them, the agency issued new guidelines that called on endoscopy centers to rigorously follow manufacturers' instructions for reprocessing and to perform "microbiological culturing on a regular basis" to check on the devices' sterility after cleaning. "Every center that does endoscopy is looking at the quality of their reprocessing and putting in a surveillance program," said John Vargo, MD, MPH, of the Cleveland Clinic, at a DDW press briefing. However, as gastroenterology fellow Ji Young Bang, MD, of Indiana University in Indianapolis, told MedPage Today, the guidelines did not specify how often the culturing should be performed and on what percentage of scopes at any given time. As a result, centers have had to decide for themselves how to follow the letter and spirit of the guidelines without going broke. In many cases, endoscopists are going beyond the manufacturers' recommended reprocessing steps to add their own extra procedures. At Maine Medical Center in Portland, for example, the hospital's Pancreaticobiliary Center has been applying an alcohol "flush and flex" protocol prior to each use -- this in addition to the standard post-use processing. At DDW, Matthew Warndorf, MD, and colleagues reported that they had experienced no endoscope-associated infections after instituting the protocol in mid-2015, during which nearly 1,800 endoscopies involving elevator-equipped instruments were performed. Bang's center simply doubled up on the manufacturers' instructions, performing the entire process twice for every instrument after use. But at both centers, and others that reported culture findings here, none of the beefed-up protocols was 100% effective at sterilizing all scopes every time. Bang, for example, said that 592 culture studies performed on 62 different scopes revealed 59 instances of residual contamination. Although 54 of these were benign organisms, that still left five with pathogenic organisms identified, including three involving enterococci. All of these were found from swabs of the elevator mechanism, a moving part at the endoscope tip that allows the operator to change the working angle of some accessory that appears to be the crux of the contamination problem. "The design of the scopes make it difficult to clean them," said Grace Elta, MD, DDW council chair and a gastroenterologist at the University of Michigan. An FDA advisory panel last year agreed that the current generation of duodenoscopes are all unsafe, but also irreplaceable and therefore must continue to be used. The panel's recommendations on more rigorous adherence to sterilization procedures were largely reflected in the August guidance. Manufacturers' instructions generally call for the endoscope and elevator to be scrubbed with a special brush before liquid and/or gaseous sterilizers are applied. But the elevator mechanism is hinged and has other tiny crevices that appear capable of defeating all mechanical and chemical cleaners. However, said Elta, "historically the endoscope infections have related to human error. ... What most centers are doing is doing their best to eliminate that human error." This can be costly. Bang said that, because the culturing procedure means that a scope must be removed from service until it is certified contaminant-free, her center had to buy 40 new scopes in order to maintain procedure volume, at approximately $10,000 apiece. Douglas Faigel, MD, and colleagues at the Mayo Clinic in Scottsdale, Ariz., reported that they had to buy five new scopes with a list price of $223,000, and three of the unit's instruments ended up with "critical damage" from ethylene oxide gas sterilization. Meanwhile, University of Pennsylvania researchers reported that the direct costs of the culturing program amounted to a little more than $21,000 per year, although that was just for 19 duodenoscopes, each of which was cultured monthly. They did not say anything about new equipment. As for more definitive solutions, everyone asked by MedPage Today said the scope designs need to be made simpler and crevice-free. Vargo said he thought that scopes that need elevator mechanisms would eventually come with "a detachable tip that will allow cleaning." Other approaches might include removable sheaths that keep bacteria from lodging in the scope tip in the first place. An affordable single-use device would be another possibility. Manufacturers haven't publicly reported any such developments yet, Vargo said, but "I suspect in the next couple years we will see some."
Posted by Dr. Walid Y. Farah at 8:32 AM