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ACOG Issues New Guidelines On Fetal Monitoring To Resolve Inconsistencies In Interpretation
The American College of Obstetrics and Gynecology recently published new guidelines on electronic fetal monitoring in an attempt to increase consistency in the way physicians interpret and act on the results, the New York Times reports. Electronic fetal monitoring, which was introduced in the 1970s, is used during labor for more than 85% of the four million infants born alive in the U.S. annually, the Times reports. According to the Times, use of fetal monitors became standard obstetrical practice before it was known if the benefits outweighed the risks. The new guidelines refine the meaning of various readings from fetal monitors and could help doctors make better decisions about whether to intervene during labor.According to experts, the widespread adoption of fetal monitoring has produced both negative and positive consequences, including significant increases in caesarean deliveries and the use of forceps during vaginal deliveries. Monitoring has not been found to reduce the risk of either cerebral palsy or fetal death resulting from inadequate oxygen to the fetal brain, as it was intended to do. Furthermore, lawyers commonly use monitoring results to support malpractice cases that might have little merit, which in turn has driven rising malpractice insurance costs and prompted some obstetricians to stop delivering infants.The new guidelines divide monitor readings into three categories to help doctors interpret readings more consistently. The old guidelines had two categories -- reassuring and non-reassuring -- and it was up to the obstetrician to determine whether a non-reassuring reading required intervention. Under the new guidelines, the first category applies when tracings of the fetal heart rate are normal and no specific action is required. The second category is for indeterminate tracings that require evaluation, continuous surveillance and re-evaluation. Obstetricians treating patients in this category should consider other clinical factors that could affect the fetus and whether the patient could be safely moved to category one, according to Catherine Spong of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which produced recommendations on which the guidelines are based. The final category is for abnormal tracings that require immediate evaluation and efforts to reverse the abnormal heart rate. The Times reports that more refinements to the guidelines are expected to be released in 2010 (Brody, New York Times, 7/7).

Takeda Receives FDA Complete Response Letter For Alogliptin, An Investigational Treatment For Type 2 Diabetes
Takeda Pharmaceutical Company Limited ("Takeda") announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company"s New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin.
News of the day
FDA Approves SBi's S.T.A.R.(R) Total Ankle Replacement System
Small Bone Innovations, Inc. (SBi), a leading provider of innovation, products, technology and education for the small bone & joint segment of the orthopedics industry, announced that the U.S. Food and Drug Administration (FDA) has approved SBi"s Scandinavian Total Ankle Replacement (S.T.A.R.®) system to treat U.S. patients. S.T.A.R. has received pre-market approval (PMA) to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.
Mental Health

Some Patients Are Not Notified Of Abnormal Test Results

Primary care clinicians and their staff appear to fail to inform some patients, or to fail to document informing patients, about abnormal results on outpatient medical tests, according to a report in the June 22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. "Ordering and following up on outpatient laboratory and imaging tests consumes large amounts of physician time and is important in the diagnostic process," the authors write as background information in the article. "Diagnostic errors are the most frequent cause of malpractice claims in the United States; testing-related mistakes can lead to serious diagnostic errors. There are many steps in the testing process, which extends from ordering a test to providing appropriate follow-up; an error in any one of these steps can have lethal consequences." Lawrence P. Casalino, M.D., Ph.D., of Weill Cornell Medical College, New York, and colleagues reviewed the medical records of 5,434 randomly selected patients age 50 to 69 years in 23 primary care practices (19 community-based and four affiliated with academic medical centers). The researchers identified individuals with a clinically significantly abnormal result on one of 11 blood tests or three screening tests commonly performed on an outpatient basis. These patients" records were then assessed for an indication that he or she had been informed about the abnormal result. In cases for which there was no evidence such communication occurred, physicians were sent a form alerting them to the apparent oversight and giving them the opportunity to correct the record if the patient had been informed or to inform the patient at that time. In addition, physicians responded to a six-question survey about the processes for managing test results at their practices and their satisfaction with these processes. Reviewers calculated a score ranging from zero to five for each practice, with five indicating that they closely followed five processes derived from the medical literature-routing results to the responsible physician, having the physician sign off on the results, informing the patient of all results (normal and abnormal, at least in general terms) and asking patients to call after a certain time period if they had not been notified of the results. The reviewers identified 1,889 abnormal test results and 135 apparent failures to inform the patient or to document informing the patient-a rate of 7.1 percent, or about one of every 14 tests. The average process score was 3.8; most practices did not use all five of the basic processes suggested in the literature and most did not have explicit rules for notifying patients of results. "Failure rates varied widely among practices, from 0 percent to 26 percent; practices that used better processes to manage results had lower failure rates and had physicians who were more satisfied with the processes used," the authors write. Practices that used a combination of paper and electronic records-a so-called partial electronic medical record-had the highest failure rates, whereas there was no significant difference between practices that used complete electronic medical records or paper records. "Some elements of medical care (e.g., diagnosis) are an art as well as a science, depend heavily on the cognitive skills and effort of individual physicians, involve much uncertainty and will probably always have relatively high error rates," the authors conclude. "However, notifying patients of test results does not appear to be such a process; with appropriate within-practice systems, low rates of failure to inform should be possible." Arch Intern Med. 2009;169[12]:1123-1129. Archives of Internal Medicine


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