News from Annals of Internal Medicine tip sheet July 29, 2014

Early initiation of menopausal hormone therapy (MHT) improves some markers of cardiovascular disease (CVD) but does not affect the progression of atherosclerosis, according to a study being published in Annals of Internal Medicine. CVD is the leading cause of death in women and incidence increases after menopause. Research suggests that cardiovascular benefits of MHT may be limited to women who begin treatment at a younger age, closer to menopause, or both. Researchers conducted a randomized controlled trial of MHT in women who were within 36 months of their last menses to assess effects of early initiation of oral or transdermal MHT versus placebo on rates of progression of atherosclerosis. Participants were 727 healthy women between the ages of 42 and 58 who were at low risk for CVD. Over four years, the women were randomly assigned to receive oral conjugated equine estrogens, 0.45 mg/d (n=230), transdermal 17β-estradiol, 50 mcg/d (n=222), each with 200 mg of oral progesterone for 12 days per month, or placebo (n=275). Compared to placebo, the two low-dose MHT regimens favorably altered certain CVD risk factors. However, vascular imaging at baseline and at four years showed that MHT had a neutral effect on atherosclerosis progression.

Note: The URL will go live at 5:00 p.m. on Monday, July 28 and can be included in news stories. For an embargoed PDF, please contact Megan Hanks. To speak with an author, please contact Patricia Crenshaw at patricia.crenshaw@kronosinstitute.org or 602-778-1914.

2. More information needed to determine the effectiveness of different types of decision aids for advanced care planning

Decision aids are underutilized for advanced care planning and their effectiveness is not well documented, according to an article being published in Annals of Internal Medicine. An advanced care plan is a directive that explains a patient's goals and preferences for future care in the event of serious illness or injury. Currently, less than 50 percent of severely or terminally ill patients have an advance directive in their medical record and physicians are only about 65 percent accurate in predicting patient preferences for intensive care. Decision aids are intended to help patients consider options in health care so that they may develop an advanced care plan, but little is known about their effectiveness. The authors found that many widely available decision aids have not been assessed for effectiveness, while those decision aids that have been assessed in the published empirical literature are not generally publicly available. Decision aids come in two general types; one type is constructed for the general population, while the other type is disease-specific and intended for disease-specific conditions with more predictable end-of-life scenarios and distinct choices. The researchers identified areas for improvement with regard to decision aids and suggested additional areas for research.

Note: The URL will go live at 5:00 p.m. on Monday, July 28 and can be included in news stories. For an embargoed PDF, please contact Megan Hanks. To speak with an author, please contact Matt DePoint at mdepoint@umn.edu or 612-625-4110.

3. Safety lapses at government labs raise serious bioterror concerns

Recent safety lapses at the Centers for Disease Control (CDC) and National Institute of Health (NIH) facilities illustrate a new and grave bioterror threat: the risk for disease and death emanating from biocontainment laboratories themselves, according to a commentary being published in Annals of Internal Medicine. Author, Deborah Cotton, MD, MPH, Deputy Editor of Annals of Internal Medicine, is Professor of Medicine at Boston University School of Medicine and Professor of Epidemiology at Boston School of Public Health. She is also a member of the Board of Directors of the Infectious Diseases Society of America (IDSA). Dr. Cotton says that recent lapses are so great in number and risk that it is time to suspend all research at biosafety level (BSL) 3 and BSL-4 labs until a thorough review of the incidents can be completed. She cites a recent incident at the CDC where laboratory workers improperly handled and stored live anthrax and another incident where workers inadvertently mixed the deadly H5N1 ("bird flu") influenza virus with a far more benign influenza strain and then shipped it to an outside lab. And in a lab at the heart of the NIH campus, vials of smallpox virus labeled "1954" were found sitting for decades, posing a potential risk for bioterror -- "truly the stuff of science fiction movies," Dr. Cotton writes. She suggests that many factors including human error, poor inventory control, lax or nonexistent policies, and administrative deficiencies played a role in these situations. To contain the terror within, Dr. Cotton suggests greatly limiting the number of BSL-3 and BSL-4 labs opened in the future.

Note: The URL will go live at 5:00 p.m. on Monday, July 28 and can be included in news stories. For an embargoed PDF, please contact Megan Hanks. To speak with an author, please contact Angela Collom at acollom@acponline.org or 215-351-2653.

Source: American College of Physicians